Oncology Nurse Advisor September/October 2019 by Haymarket Media

www.OncologyNurseAdvisor.com

September/October 2019

NURSE-PATIENT COMMUNICATIONS

FEATURE

Anticipation, Management of PTSD in Cancer Patients

FROM CANCERCARE

How to Build a Successful Relationship With Hispanic Patients

Cost of Care, Financial Toxicity, and Adherence: An Essential Discussion Helping patients plan how to mix medicine and money is key to optimizing their outcomes.

RADIOLOGY & YOUR PATIENT

QOL Outcomes With HRT Noninferior to CRT

THE TOTAL PATIENT

How Effective Are Popular Palliative Care Interventions?

COMMUNICATION CHALLENGES

Fernweh: A Longing for What Will Be Missed

ISSUES IN CANCER SURVIVORSHIP

PRSRT STD US POSTAGE PAID PONTIAC IL PERMIT #60

Can the Use of Vitamin D Supplements Improve PFS and RFS in GI Cancers?

PUBLISHING STAFF

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Senior digital content editor Rick Maffei Oncology writer Susan Moench, PhD, PA-C Contributing writers Bryant Furlow Ann J. Brady, MSN, RN-BC, CHPN Bette Weinstein Kaplan Lisa A. Thompson, PharmD, BCOP Group creative director, Haymarket Medical Jennifer Dvoretz Graphic designer Vivian Chang Production editor Kim Daigneau

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HAYMARKET MEDIA Managing editor, Haymarket Oncology Lauren Burke VP, Content; Medical Communications Kathleen Walsh Tulley

EDITORIAL BOARD Eucharia Borden, MSW, LCSW, OSW-C Lankenau Medical Center Wynnewood, Pennsylvania Jiajoyce R. Conway, DNP, CRNP, AOCNP Cancer Care Associates of York York, Pennsylvania Leah A. Scaramuzzo, MSN, RN-BC, AOCN Kalispell Regional Healthcare Kalispell, Montana Lisa A. Thompson, PharmD, BCOP Kaiser Permanente Colorado Rosemarie A. Tucci, RN, MSN, AOCN Lankenau Hospital Wynnewood, Pennsylvania

General Manager, Medical Communications Jim Burke, RPh President, Medical Communications Michael Graziani CEO, Haymarket Media Inc Lee Maniscalco

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Oncology Nurse Advisor (ISSN 2154-350X), September/October 2019, Volume 10, Number 5. Published 6 times annually by Haymarket Media Inc, 275 7th Avenue, 10th Floor, New York, NY 10001. For Advertising Sales & Editorial, call (646) 638-6000 (M-F, 9am-5pm, ET). Postmaster: Send changes of address to Oncology Nurse Advisor, P.O. Box 316, Congers, NY 10920. Copyright © 2019. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing from the publisher.

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CONTENTS 5

September/October 2019

IN THE NEWS • Nurse-Rated Status Better Outcomes Predictor • CMS Increases Reimbursement Rate for Product Cost of CAR-T Therapy • FDA Halts 2 Studies Evaluating Addition of Pembrolizumab to MM Treatment Regimens • Effects of Dose Reductions in FEC-D for Early Stage Breast Cancer • Premedication With Dexamethasone May Prevent Premetrexed-Associated Skin Rash

… and more

ONCOLOGY NURSE ADVISOR FORUM • Aloe Vera for Radiotherapy-Related Skin Reactions • Best Practices for Handling BCG Waste

NAVIGATOR NOTES US Task Force Recommends New Criteria for Genetic Testing, Counseling Megan Garlapow, PhD

FEATURES Cost-of-Care: How to Facilitate This Essential Conversation Tiffany Garbutt, PhD

Anticipation and Management of Posttraumatic Stress Disorder Bette Weinstein Kaplan

www.OncologyNurseAdvisor.com • SEPTEMBER/OCTOBER 2019 • ONCOLOGY NURSE ADVISOR 3

FEATURE Telehealth Ushering in a New Era in Cancer Care

CONTENTS 27

September/October 2019

COMMUNICATION CHALLENGES A Longing for What Will Be Missed

Nurses at the forefront of telehealth practices share their views on how technology is expanding the reach of clinicians, improving cancer care for patients, and the barriers yet to be overcome John Schieszer

JOURNAL REVIEW

Ann J. Brady, MSN, RN-BC, CHPN

Comparison Study Shows Predictive Value for CSCC of the Head and Neck of BWH vs AJCC 8

ISSUES IN CANCER SURVIVORSHIP Can Vitamin D Supplements Improve PFS and RFS in Gastrointestinal Cancers?

John Schieszer

Researchers compared the accuracy of the BWH Tumor Classification System for classifying tumors with that of AJCC 8, as well as their sensitivity and specificity for predicting poor outcomes.

Bette Weinstein Kaplan

FACT SHEETS Hormone Therapy for Breast Cancer

THE TOTAL PATIENT How Effective Are Popular Palliative Care Interventions for Patients With Cancer? Bette Weinstein Kaplan

RADIATION & YOUR PATIENT QOL Outcomes With HRT for Prostate Cancer Not Inferior to CRT Bryant Furlow

FROM CANCERCARE How to Build a Successful Relationship With Hispanic Patients Lucia Fanjul, MSW, LMSW

ASK A PHARMACIST FDA Recall of Several ARBs; Options for Safe Disposal of Drugs Lisa A. Thompson, PharmD, BCOP

The use of hormone therapy for breast cancer and possible side effects of treatment Medical Treatments for Chronic Myelogenous Leukemia

Educational fact sheet about the causes of and treatment options for CML PUBLISHERS’ ALLIANCE: DOVE PRESS Primary Spinal Epidural Diffuse Large B-Cell Lymphoma With Paraplegia as the First Manifestation: A Case Report

A diagnosis of spinal epidural DLBCL was made after 2 misdiagnoses and surgery. The authors explain when to suspect PSEL in patients with spinal cord compression. OncoTargets and Therapy

ON THE

WEB

4 ONCOLOGY NURSE ADVISOR • SEPTEMBER/OCTOBER 2019 • www.OncologyNurseAdvisor.com

IN THE NEWS Nurse-Rated Status Better Outcomes Predictor Evaluations of patient performance status are fundamental to guiding treatment decisions and providing estimates of prognosis for patients with cancer. Previous studies have shown discrepancies between performance status assessments performed by nurses and those by oncologists, with the latter group more likely to provide “healthier” scores relative to the former. However, whether evaluations of performance status by these 2 clinician groups differ with respect to their ability to predict patient clinical outcomes remains unclear. This retrospective cohort study included 311 adult patients (median age, 64 years) with solid tumor cancers treated at the Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute in Los Angeles, California. These patients were randomly selected from a larger group of patients included in a previously conducted prospective study in which both prescribing oncologists and chemotherapy infusion nurses independently assessed their performance status. Assessments of patients receiving intravenous chemotherapy with either palliative or curative intent were performed using Eastern Cooperative Oncology Group – Performance Status (ECOG-PS) on the day the chemotherapy was administered; all treatment decisions were made by the oncologists. ECOG-PS scores were retrospectively collected, and data related to patient demographics, the incidence of serious adverse effects within 1 month, the hospitalization rate within 1 month, and the occurrence of death or hospice referral within 6 months of chemotherapy administration were assessed from the patient medical records by blinded reviewers. Overall, ECOG-PS scores were in agreement between nurses and oncologists in 70.7% of cases. But, significant correlations between ECOG-PS scores provided by nurses and the incidence of grade 3/4 adverse events occurring at 1 month (odds ratio [OR], 1.44; 95% CI, 1.06-1.96; P =.021), as well as the 1-month hospitalization rate (OR, 1.57; 95% CI, 1.02-2.42; P =.041) were noted, whereas assessments performed by oncologists did not significantly correlate with these 2 clinical outcomes. With respect to 6-month mortality or hospice referral, there was a significant correlation between ECOG-PS scores provided by both nurses and oncologists. Interestingly, disagreement between the ECOG-PS scores provided by nurses and those provided by oncologists was itself significantly predictive of worse patient clinical outcome when oncologists’ scores were lower. Read more at https://bit.ly/2khocSC.

Clinical Practice Guideline Update Focuses on Prevention and Management of MRONJ The incidence of medication-related osteonecrosis of the jaw (MRONJ) in patients with cancer is estimated to be between 1% and 9%. Clinical sequelae of this frequently difficult-to-treat condition include significant pain and quality of life detriments. For the purposes of this clinical practice guideline update, MRONJ was defined by the MASCC/ISOO/ASCO Expert

Consensus Panel as the persistence — longer than 8 weeks — of exposed bone or bone accessible through a fistula in either the maxilla or the mandible of patients with a current or previous history of receiving oncologic doses of bone modifying agents (BMAs), such as bisphosphates or denosumab, or an anti-angiogenic agent, who do not have a history of either metastatic disease to the jaws or the delivery of radiation therapy to the jaws. However, due to the limited evidence regarding the association between anti-angiogenic

www.OncologyNurseAdvisor.com • SEPTEMBER/OCTOBER 2019 • ONCOLOGY NURSE ADVISOR 5

IN THE NEWS

Read more at https://bit.ly/2lUf1rO.

Reductions in cumulative dose of the third-generation adjuvant chemotherapy regimen 5-fluorouracil, epirubicin, and cyclophosphamide followed by docetaxel (FEC-D) were associated with worse survival outcomes in women with stage I-III HER2-negative breast cancer. Results of previous research demonstrated that administering a first-generation adjuvant chemotherapy regimen (cyclophosphamide, methotrexate, fluorouracil [CMF]) was associated with substantial overall survival benefits in women with earlystage breast cancer. Furthermore, reductions in the cumulative dose intensity of CMF — to less than 85% of full cumulative intensity — were shown to have a negative impact on survival. Although additional survival benefits have been associated with the addition of an anthracycline or a taxane to adjuvant chemotherapy for breast cancer, similar results regarding the negative effects of reductions in total cumulative dose of cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) and FEC have also been shown. Nevertheless, the effect on survival of dose reductions in third-generation adjuvant chemotherapy regimens for breast cancer that include both an anthracycline and a taxane, such as FEC-D, is less well understood. This retrospective study included women with stage I-III HER2-negative breast cancer that was either hormone receptor-positive or -negative between 2007 and 2014 who had received between 4 and 6 cycles of adjuvant chemotherapy with FEC-D and at least 1 cycle of docetaxel (D) and were identified in the Alberta Cancer Registry. Of the 1302 patients included in the study, 1100 received at least 85% of total cumulative FEC-D dose and 202 received less than 85% of total cumulative dose. Although the women who received a higher cumulative dose of chemotherapy were more likely to be younger and premenopausal, the

Premedication With Dexamethasone May Prevent Pemetrexed-Associated Skin Rash Intravenous (IV) dexamethasone prophylaxis showed efficacy in prevention of cutaneous reactions associated with pemetrexed treatment for pulmonary adenocarcinoma. This retrospective study focused on prophylaxis efficacy outcomes for Overall, skin rashes patients being treated for pulmonary were grades 1 or 2. adenocarcinoma with pemetrexed. Patients received prophylactic dexamethasone in either the standard oral formulation (n=31) or a 20-mg IV form (n=39). Efficacy was assessed based on reports of both the incidence and intensity of cutaneous reactions throughout cycles of chemotherapy. Among all patients receiving oral dexamethasone, skin rashes occurred with 9 of 154 cycles (5.8%). For patients given IV dexamethasone, skin rashes happened with 10 of 114 cycles (8.9%; P =.35). Cutaneous reactions occurred most often during the first or second cycles for patients in either group. A total of 5 patients (16.1%) in the oral dexamethasone group and 9 patients (23.1%) in the IV dexamethasone group experienced skin rashes (P =.56). Overall, skin rashes were considered to be exclusively of grades 1 or 2. The rashes were grade 1 in 88.9% of the cases with oral dexamethasone and in 90% of those with IV dexamethasone (P =.66). In a subgroup analysis, skin rashes were seen most often in patients treated with carboplatin with pemetrexed. ■ Read more at https://bit.ly/2mnkMPb.

8 ONCOLOGY NURSE ADVISOR • SEPTEMBER/OCTOBER 2019 • www.OncologyNurseAdvisor.com

(42 patients), supportive care (42 patients), antimicrobial agents (21 patients), or immunosuppressive treatment (12 patients). Mucosal ulceration on endoscopy occurred in 9 patients. Characteristics of active inflammation per histological analysis occurred in 52 patients. Hospital admission was required for 39 patients, with 2 patients admitted to the intensive care unit. Although these results indicate rituximab-associated colitis is typically mild and requires only supportive care, occasionally it can be severe and result in perforation of the colon and admission to the intensive care unit.

ONCOLOGY NURSE ADVISOR FORUM Our Consultants Ann J. Brady, MSN, RN-BC, CHPN, symptom management care coordinator at the Cancer Center, Huntington Hospital, Pasadena, California.

Jiajoyce R. Conway, DNP, CRNP, AOCNP, oncology nurse practitioner at Cancer Care Associates of York in York, Pennsylvania.

Donald R. Fleming, MD, hematologist/oncologist, Cancer Care Center, Davis Memorial Hospital, Elkins, West Virginia.

K. Lynne Quinn, RN, MSN, CRNP, AOCNP, director of oncology, Bryn Mawr Hospital and Bryn Mawr Health Center, Bryn Mawr, Pennsylvania.

Lisa A. Thompson, PharmD, BCOP, clinical pharmacy specialist in oncology, Kaiser Permanente, Colorado.

ALOE VERA FOR RADIOTHERAPY-RELATED SKIN REACTIONS I have had several patients who are undergoing radiation therapy apply aloe vera to their skin. Should aloe vera be used on the skin to prevent radiodermatitis? — Name withheld upon request Research shows that aloe vera is ineffective and may worsen skin reactions from radiation. Cleansing the skin daily with mild moisturizing soaps has been found to be most beneficial. Evidence supporting the use of aloe vera for prevention and treatment of radiotherapy-related skin effects is controversial. For example, a 3-arm randomized study that compared a moist aloe extract with a dry skin care regimen and placebo found aloe was not effective for prophylaxis or treatment in patients with breast cancer.1 However, a recent study found aloe vera was moderately effective when used in combination with mild soap vs soap alone.2 These authors also reported aloe vera may be effective in patients whose cumulative radiation doses are more than 2700 cGy and for patients who experience acute radiation proctitis. — Leah A. Scaramuzzo, MSN, RN-BC, AOCN

BEST PRACTICES FOR HANDLING BCG WASTE We use a closed system at our facility, except for connecting the bacillus Calmette-Guérin (BCG) tubing to the catheter. What is the proper procedure for handling BCG waste? Does the room need to be closed off after instilling the drug into the bladder? If so, for how long? — Name withheld on request Bacillus Calmette-Guérin waste should be handled as biohazardous waste, including the use of personal protective equipment when handling any parts of BCG as it is a live, attenuated mycobacteria. Given that there have been reports of nosocomial infections reported in patients receiving parenteral drugs that were prepared in areas where BCG was reconstituted, best practices would agree to close off the room where BCG has been administered. This is an infectious agent that can infect others. Patients are even instructed to disinfect voided urine with an equal volume of bleach for 15 minutes before flushing for the first 6 to 8 hours after instillation.3 Most institutions close off the room for 8 hours a day and that is inclusive of pre- and postprocedure. The FDA’s recommendations are that of standard safe handling practices without specific references to closing off areas of treatment. — Jiajoyce R. Conway, DNP, CRNP, AOCNP REFERENCES 1. Hoopfer D, Holloway C, Gabos Z, et al. Three-arm randomized phase III trial: quality aloe and

Rosemarie A. Tucci, RN, MSN, AOCN, manager for oncology research & data services, Lankenau Hospital, Wynnewood, Pennsylvania.

placebo cream versus powder as skin treatment during breast cancer radiation therapy. Clin Breast Cancer. 2015;15(3):181-190.e1-4. 2. Farrugia CE, Burke ES, Haley ME, Bedi KT, Gandhi MA. The use of aloe vera in cancer radiation: an updated comprehensive review. Complement Ther Clin Pract. 2019;35:126-130. 3. Tice® BCG Live [package insert]. Roseland, NJ: Organon USA Inc; 2009. https://www.fda.gov/ media/76396/download. Accessed August 23, 2019.

www.OncologyNurseAdvisor.com • SEPTEMBER/OCTOBER 2019 • ONCOLOGY NURSE ADVISOR 9

NAVIGATOR NOTES US Task Force Recommends New Criteria for Genetic Testing, Counseling Megan Garlapow, PhD

NEW INCLUSIONS

In its 2019 recommendation, the USPSTF recommends evaluating women who have a personal or family history of peritoneal, fallopian tube, ovarian, or breast cancer or who have ancestry with harmful mutations in the BRCA1/2 genes with a familial-risk assessment tool. Patients who receive a positive result on the risk-assessment tool should receive genetic counseling and genetic testing if indicated.1 For women without a personal or family history of these cancers or a family history of harmful BRCA1/2 mutations, the USPSTF recommends against routine risk assessment, genetic counseling, and genetic testing.1

Nurse navigators are likely to play an important role in facilitating thorough, in-depth conversations with patients about routine assessment, genetic counseling, and genetic testing. In fact, a 2015

study on efficiency in identifying cancer patients who should undergo genetic and genomic testing indicated nurse navigators were particularly well positioned in the continuum of cancer care to facilitate timely testing in compliance with recommendations from the National Comprehensive Cancer Network.2 SUPPORT FOR THE UPDATES To update their recommendations, the USPSTF evaluated evidence on risk assessment, genetic counseling, and genetic testing for BRCA1/2 mutations in women without symptoms who had never been diagnosed with a BRCA-related cancer and in women with a prior diagnosis of peritoneal, fallopian tube, ovarian, or breast cancer. Recommendations indicated a moderate (grade B) benefit to assessment, genetic counseling, and genetic testing in women with a family or personal history that correlated with increased risk for peritoneal, fallopian tube, ovarian, or breast cancer or who have family with harmful BRCA1/2 mutations. For women without such personal or family history of cancer or BRCA1/2 mutations, the USPSTF gave a grade D recommendation, discouraging the service from being used.1 A grade of B means the USPSTF recommends the service offered as having “high certainty that the net benefit is moderate, or there is moderate certainty that the net benefit is moderate to substantial.” A grade of D means the USPSTF discourages the use of the service as having “moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.”1

Nurse navigators are likely to play an important role in facilitating thorough, in-depth conversations with patients. 10 ONCOLOGY NURSE ADVISOR • SEPTEMBER/OCTOBER 2019 • www.OncologyNurseAdvisor.com

armful mutations in the BRCA1 and BRCA2 genes (BRCA1/2) are correlated with increased risk for developing peritoneal, fallopian tube, ovarian, male and female breast, pancreatic, and aggressive prostate cancers. The United States Preventive Services Task Force (USPSTF) recently updated their recommendations for risk assessment, genetic counseling, and genetic testing for BRCA1/2-related cancers from their 2013 recommendation.1 Breast cancer is the most common cancer following nonmelanoma skin cancer in women in the United States, and it is the second leading cause of cancer death. BRCA1/2 mutations occur in approximately 1 in 300 to 500 women, and these mutations account for 5% to 10% of cases of breast cancer and 15% of cases of ovarian cancer.1

If no cancer history exists, USPSTF gave screening a grade D recommendation.

Notably, this updated recommendation now includes women with a previous history of breast or ovarian cancer who are considered cancer-free and includes ancestry as a risk factor. A perspective piece contextualizing the USPSTF recommendation also noted that “importantly, but not included in this recommendation, BRCA1/2 status is relevant for patients with newly diagnosed early stage breast cancer for surgical decision making and can also be used to determine appropriate treatment of certain advanced cancers.”3 Although the authors of this perspective emphasized the importance of expanding the USPSTF recommendation, they also lauded the clear recommendation of identifying patients with deleterious BRCA1/2 mutations as potentially “lifesaving and should be a part of routine medical care.”3

respond to estrogen-receptor modulators or aromatase inhibitors. “[A]s with any other guideline, it remains imperative for clinicians to exercise clinical judgment and to be mindful of patient subsets that do not necessarily fit into recommendations designed for the majority or general populations.”4 The recommendation’s expansion of patients eligible for screening and clear inclusion of ancestry associated with BRCA1/2 mutations improves its utility, although opportunity remains for specific recommendations for subgroups of patients beyond the general population. ■

research is needed to better understand how women with an unknown family history should be assessed for BRCA1/2 mutation risk,” explained the USPSTF in its recommendation. The task force also suggested a need to understand the optimal mode of delivery for genetic counseling, for an expanded database of patients receiving genetic counseling for heritable breast or ovarian cancer who are tested for BRCA1/2 mutations, and research about the efficacy of intensive cancer screening and risk-reducing drugs on long-term clinical outcomes.1

WHAT WAS NOT COVERED

NONSPECIFIC TO SUBGROUPS

BRCA-related cancer: US Preventive Services

The recommendation did not cover management of BRCA1/2 mutationrelated increased cancer risk, but it still noted that interventions to lower cancer risk, such as intensive screening, riskreducing medications, and risk-reducing mastectomy and salpingo-oophorectomy, are a part of care for women with harmful BRCA1/2 mutations.1 More recent advances in understanding the role of deleterious mutations in BRCA1/2 genes in the development of various types of cancer have not abrogated the need for better elucidating risk assessment and testing in the general population. “Because risk assessment is primarily based on family history, more

As Lisa Newman, MD, MPH, of the Breast Center at Weill Cornell Medicine in New York, New York, pointed out in an accompanying editorial published in JAMA Surgery, the USPSTF statement fails to address the variability in breast tumor phenotypes and disparities in genetic testing referrals for African American women, a population with a particularly high rate of triple-negative breast cancer (TNBC). Additionally, as Dr Newman pointed out, it does not take into consideration the unclear role of chemopreventive intervention in BRCA1 mutation carriers, especially as BRCA1-associated breast cancer is predominantly TNBC so does not

Task Force Recommendation Statement.

Megan Garlapow is a medical writer based in Tempe, Arizona. REFERENCES 1. US Preventive Services Task Force; Owens DK, Davidson KW, Krist AH, et al. Risk assessment, genetic counseling, and genetic testing for

JAMA. 2019;322(7):652-665. 2. McAllister KA, Schmitt ML. Impact of a nurse navigator on genomic testing and timely treatment decision making in patients with breast cancer. Clin J Oncol Nurs. 2015;19(5):510-512. 3. Domchek S, Robson M. Broadening criteria for BRCA1/2 evaluation: placing the USPSTF recommendation in context. JAMA. 2019;322(7):619-621. 4. Newman L. US Preventive Services Task Force breast cancer recommendation statement on risk assessment, genetic counseling, and genetic testing for BRCA-related cancer [published online August 20, 2019]. JAMA Surg. doi:10.1001/jamasurg.2019.3184

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www.OncologyNurseAdvisor.com • SEPTEMBER/OCTOBER 2019 • ONCOLOGY NURSE ADVISOR 11

FEATURE | Nurse-Patient Communications

Cost-of-Care: How to Facilitate This Essential Conversation An up-close look at the cost of cancer care, current legislative actions, and tools clinicians can use to help ease patients’ financial burden.

Helping patients plan how to mix medicine and money is key to optimizing their outcomes.

TIFFANY GARBUTT, PHD

oth the American Society of Clinical Oncology (ASCO) and the National Academy of Medicine recognize cost-ofcare conversations to be an important aspect of the clinician-patient relationship and an essential component of high-quality cancer care.1 Financial toxicity has been shown to play an important role in treatment success. Increased cost of care or unexpected financial difficulties are linked with lower patient adherence, delayed or forgone care, and higher mortality.2-4 In fact, as many as 35% of American adults report not getting medical care because of out-of-pocket costs.5,6 “Discussions between patients and clinicians about the costs of cancer care have the potential to improve care delivery and outcomes for patients by fostering informed decision making,” said Ryan Nipp, MD, MPH, of the Massachusetts General Hospital Cancer Center during the 2018 ASCO Annual Meeting.1 Overall, patients have expressed a desire for more help from health care providers in addressing the cost of treatment.7,8 Approximately 62% of cancer patients are in debt due to treatment, 42% deplete their life savings within the first 2 years of cancer treatment, and 3% may even have to fi le for bankruptcy.9,10 Yet despite the recognized importance by both physicians and patients, such cost-of-care conversations rarely occur.6,11,12 In a study of federally qualified health centers, cost-of-care conversations occurred in only 11.9% of physician-patient encounters.13 There is a surprising discordance between physicians

12 ONCOLOGY NURSE ADVISOR • SEPTEMBER/OCTOBER 2019 • www.OncologyNurseAdvisor.com

and patients about the occurrence of cost-of-care conversations. A study by Reshma Jagsi, MD, DPhil, and colleagues assessed the perspectives of more than 300 oncologists and 2502 patients with early stage breast cancer. Approximately 50% of the medical oncologists reported that someone in their practice discusses finances with patients. In contrast, 72.8% of worried patients reported that they did not get help from their health care providers.7 WHAT’S THE PRICE TAG? A new rule introduced by the Trump administration may help to initiate more cost-of-care conversations between physicians and patients. It would require pharmaceutical companies to disclose the cost of prescription drugs that cost more than $35 per month and to display the price in clear, legible font for a sufficient amount of time on television advertisements.14 “Requiring drug companies to level with patients about their drug prices is about working towards a system where the patient — not the insurer, not the drug company, not the government, but the patient — is in control. We are moving from a system that leaves patients in the dark to one that puts them in the driver’s seat,” said Alex Azar, secretary of Health and Human Services, at a recent press conference.15 In response to the rule, a group of pharmaceutical companies including Merck, Eli Lilly, and Amgen recently sued the Trump administration. They disputed that the new

Cost of care and financial toxicity do not refer to just the price of drugs, treatments, or diagnostic tests. It also encompasses many indirect costs. rule would violate the companies’ rights under the First Amendment, which provides protections for advertisers. They further reasoned that disclosing the list price of drugs may mislead consumers. “We believe the new requirements may cause patients to decide not to seek treatment because of their perception that they cannot afford their medications, when in fact many patients do not pay anything near list price,” said Merck.16 Indeed, a recent study by Jace B. Garrett, PhD, CMA, and colleagues found that disclosing drug prices may lower consumer interest in high-priced drugs, but that the effect could be counteracted if the advertisement included a statement

that consumer out-of-pocket costs might be zero.17 As such, several pharmaceutical companies have set up websites detailing potential out-of-pocket costs and sources of financial assistance.16 In June 2019, a federal court judge ruled in favor of the pharmaceutical companies to block the new regulation.18 Many experts agreed that the regulation would have little to no effect on consumer purchasing or on lowering drug prices, largely because patients have limited drug options and need these drugs to survive.14,15 Yet, some experts contend that it had the potential to act as an opportunity for patients to better understand the pharmaceutical landscape and would have facilitated more physician-patient cost-of-care conversations.15 “Even for the patient with insurance who only has to pay a low fixed copay, the disclosure of the list price is educational to patients wondering why their health plan premiums are rising so quickly. Some patients will be swayed to ask about alternatives if they know the price is high and prescribers seeing the same ads will also be more aware of the price,” said C. Michael White, PharmD, a pharmacist and professor at the University of Connecticut School of Pharmacy.15 BARRIERS TO COST-OF-CARE CONVERSATIONS Cost of care and financial toxicity do not refer to just the price of drugs, treatments, or diagnostic tests. They also encompass a variety of indirect costs such as missed work, income loss, disability, transportation, and childcare expenses.1,6 The sensitivity of discussing such topics may make some clinicians apprehensive. In addition, health care providers may have difficulty identifying if a patient is suffering with financial distress.1,6,19 A recent study presented at the 2019 ASCO Annual Meeting suggests that some patients, particularly those with annual household incomes of less than $50,000, are more interested in having cost-of-care conversations than other patients.20 Many physicians may also feel ill-equipped to discuss alternative cost-reduction strategies due to a lack of awareness of patient-specific financial and personal situations, resources for mitigating patient-specific costs, and alternative treatments to aid in such cost reduction.1,6,19 Additionally, physicians may only have a limited amount of time with patients, which may inhibit the rapport needed to discuss patient-specific financial toxicity concerns. As such, physicians may designate nurse navigators or nonmedical staff to conduct cost-of-care conversations.1,4,21 In a 2019 study, Maria Pisu, PhD, and colleagues made the surprising discovery that some patients preferred having costof-care conversations with nurses or nonmedical staff largely because these health care professionals were viewed as having

www.OncologyNurseAdvisor.com • SEPTEMBER/OCTOBER 2019 • ONCOLOGY NURSE ADVISOR 13

FEATURE | Nurse-Patient Communications more time to commit to conversations, which may become lengthy and personal.21 Designating a specific member of the staff to handle cost-of-care conversations also ensures that this person can be well versed in available patient resources, current drugs, and potential cost-reduction strategies. RESOURCES FOR HEALTH CARE PROVIDERS The American College of Physicians (ACP) has developed a number of free online resources to aid health care professionals and patients with cost-of-care conversations. One such tool, the “Cost Distress Screening Tool,” can tactfully aid health care providers in identifying patients with potential financial distress. The ACP’s resource, “Cost of Care Resources for Clinicians and Patients,” helps providers identify potential solutions once distress about a treatment cost is identified. Furthermore, the ACP tool, “Medical Treatment Cost Planning,” provides a comprehensive outlook of an entire treatment plan including medical and nonmedical costs for both providers and patients. Additional ACP resources include instructional videos for health care providers on how to initiate and navigate cost-of-care conversations.6

of strategies to mitigate financial toxicity are equally vital. Rising or unexpected health care costs cause patients profound distress, which in turn can decrease treatment effectiveness. Truly effective cost-of-care conversations not only inform patients of the financial burden before them but allow them to be active participants in mitigating the direct and indirect costs of cancer treatment, leading to better patient outcomes. ■ Tiffany Garbutt is a medical writer based in Cary, North Carolina. REFERENCES 1. Rosenberg J. Talking about the cost of cancer care with patients. Oncology Nursing News; June 12, 2018. https://www.oncnursingnews. com/web-exclusives/talking-about-the-cost-of-cancer-care-withpatients. Accessed September 27, 2019. 2. Dusetzina SB, Winn AN, Abel GA, Huskamp HA, Keating NL. Cost sharing and adherence to tyrosine kinase inhibitors for patients with chronic myeloid leukemia. J Clin Oncol. 2014;32(4):306-311. 3. Tipirneni R, Politi MC, Kullgren JT, Kieffer EC, Goold SD, Scherer AM. Association between health insurance literacy and avoidance of health care services owing to cost. JAMA Netw Open. 2018;1(7):e184796. 4. Sloan CE, Ubel PA. The 7 habits of highly effective cost-of-care conversa-

The ACP has developed a number of free online resources to aid health care professionals and patients with cost-of-care conversations.

tions. Ann Intern Med. 2019;170(9_Supplement):S33-S35. 5. Fewer adults report not getting needed care because of costs, but gains have stalled in recent years. The Commonwealth Fund; February 7, 2019. https://www.commonwealthfund.org/chart/2019/fewer-adultsreport-not-getting-needed-care-because-costs-gains-have-stalledrecent. Accessed September 27, 2019. 6. Dine CJ, Masi D, Smith CD. Tools to help overcome barriers to cost-of-

The America’s Essential Hospitals association also provides a number of free resources in their online library (TalkCostofCare.org). The practice briefs provided in this tool are particularly helpful in providing methods to improve costof-care conversations.6 Dr Pisu’s report also provides sample sentences based on direct patient quotes that reflect how patients would like providers to approach such discussions.21 Notably, cost-of-care conversations should also include an aspect of patient empowerment. In addition to being conducted by a knowledgeable navigator such conversations should also provide tools that patients can assess and understand on their own time. Providing such resources in the form of fliers or online tools has been shown to be effective in reducing patient distress and facilitating further cost-of-care discussions with providers.1,4,6,22 One such resource, termed “A Helping Hand,” offered by CancerCare, provides an online tool where patients can access information about financial assistance based on their specific diagnosis and zip code.1 Receiving the best course of treatment regardless of its cost is the top priority for both physicians and patients, but discussions

care conversations. Ann Intern Med. 2019 May 7. DOI: 10.7326/M19-0778 7. Jagsi R, Ward KC, Abrahamse PH, et al. Unmet need for clinician engagement regarding financial toxicity after diagnosis of breast cancer. Cancer. 2018;124(18):3668-3676. 8. Simon S. Cancer patients want more information from doctors about cost. American Cancer Society website; August 13, 2018. https://www. cancer.org/latest-news/cancer-patients-want-more-information-fromdoctors-about-cost.html. Accessed September 27, 2019. 9. Gilligan AM, Alberts DS, Roe DJ, Skrepnek GH. Death or debt? National estimates of financial toxicity in persons with newly-diagnosed cancer. Am J Med. 2018;131(10):1187-1199.e5. 10. Beres D. 42% of new cancer patients lose their life savings. Big Think website; October 17, 2018. https://bigthink.com/politics-current-affairs/ how-much-does-cancer-cost. Accessed September 27, 2019. 11. Alexander GC, Casalino LP, Meltzer DO. Patient-physician communication about out-of-pocket costs. JAMA. 2003;290(7):953-958. 12. Shih YT, Chien CR. A review of cost communication in oncology: patient attitude, provider acceptance, and outcome assessment. Cancer. 2017;123(6):928-939. References continue on page 26

14 ONCOLOGY NURSE ADVISOR • SEPTEMBER/OCTOBER 2019 • www.OncologyNurseAdvisor.com

FEATURE | Adverse Effect Management

Anticipation and Management of Posttraumatic Stress Disorder A review of the causes of cancer-related PTSD and steps oncology nurses can take to ease its burden on patients and their caregivers.

Anger, frustration, and strong negative emotions may indicate a risk of PTSD, but less assertive reactions also indicate a patient is at risk.

BETTE WEINSTEIN KAPLAN

ll types of battles can cause posttraumatic stress disorder (PTSD). Fighting cancer is one of them. A multidisciplinary team of oncology nurses and other practitioners recently reported on cancer-related PTSD and how oncology nurses can help their patients with this newly defined disorder.1,2 PTSD is the result of a person’s inability to recover from a traumatic event. A constant fear of re-experiencing the event persists through nightmares or flashbacks of the trauma. Its symptoms become pathological if accompanied by associated distress and difficulty functioning for more than a month after the traumatic event. The Diagnostic and Statistical Manual of Mental Disorders Fourth Edition-Text Revision (DSM-IV-TR) expanded the definition of a traumatic event to include receiving a diagnosis of a life-threatening illness.3 These definitions were adjusted again in the latest edition, the DSM-5, to specify that a diagnosis of cancer-related PTSD requires patients to have experienced a traumatic, catastrophic event during their cancer diagnosis or treatment.4 A TRAUMATIC STRESSOR Memories related to trauma and those stemming from nontraumatic events are different. The latter are voluntary and are usually not associated with whole body experiences. Not surprisingly, the American Psychiatric Association recognizes cancer as a traumatic stressor that can result in PTSD. Approximately one-third of patients with cancer suffer from emotional distress severe

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Adverse Effect Management |

enough to require a psychosocial intervention during their oncology treatment.1,2 This does not mean that all patients who require psychiatric help actually get it when they need it. Clinicians may not recognize that a patient should be referred, or the patient and/or loved ones may consider theirs a normal reaction. Some patients may try to hide what they are feeling, believing that a negative reaction to their illness or treatment will also have a negative effect on their immune system, so they try to suppress their reactions. However, researchers have found that suppressing these normal responses is more damaging than processing them. Suppression can result in depression, difficulty sleeping, and difficulty communicating, which in turn affect treatment compliance and participation in a healing and healthful lifestyle. Studies have shown that when patients with cancer are able to process their normal negative reactions using psychological interventions, their quality of life improves. Those whose distress is not treated are less adherent to their treatment and surveillance, which results in worse disease outcomes.1,2 THE FEAR FACTOR The negativity and fear associated with cancer are so strong that some people seem to believe the word itself has power, referring to cancer as “the big C” or “the C word.” Cancer is certainly powerful. Survivors suffer terribly and form associations with their illness that can be unforgiving. For example, researchers have described how the sight of pink ribbons triggered PTSD in a patient with breast cancer, so she avoids going into many places that actively support the campaign.1,2 This author had one friend who vomited every time she set foot in the doorway of the cancer center where she had been treated with a brutal chemotherapy agent. The course of cancer is filled with trauma-causing moments, from diagnosis through treatment and into survival. Patients undergo diagnostic tests followed by anxious and seemingly

Acceptance of cancer-related PTSD as a diagnosis acknowledges that these experiences are part of cancer and need treatment. unending periods of waiting for results that are then followed by a terrible acknowledgment. Even then, there is no let-up of anxiety. Denial is impossible as it’s time to begin a treatment plan. The patient must now find the strength to bear the additional trauma of undergoing cancer treatment, because no one can do this for her. Along the way, the patient deals

FEATURE

with further trauma as she deals with more testing, therapeutic interventions and their side effects, possible surgery, more testing, scans, and so on. If the patient gets through all of that and comes out the other side as a survivor, she has to gird herself against trauma every time she has a follow-up appointment or scan, every time she looks in the mirror, or feels a new possible symptom, or even when she hears that someone else has died of cancer. Acceptance of cancer-related PTSD as a diagnosis acknowledges that these experiences are part of cancer and need treatment. WHO IS VULNERABLE? Oncology nursing is an ideal role for helping the patient with cancer-related PTSD. Communication between nurses and patients provides an optimal opportunity to assess, comfort, inform, and assist patients. It provides guidance that helps the nurse identify those patients at risk, especially since some risk factors for developing PTSD are easy to spot, such as young age. Another characteristic is the tendency to have rapid, strong emotional reactions to adverse events — a hallmark of neuroticism. Someone who has a history of substance use or dependency, a mood disorder, or who has a negative affect or a stress-prone personality may be more susceptible to developing PTSD. Interestingly, the researchers suggest that people who are less assertive may be more at risk of developing cancer-related PTSD because their tendency to feel somewhat powerless may keep them from expressing their emotional concerns to their nurse or others.2 Of course, the waiting period between diagnostic testing and receiving the results is fraught with terrible anxiety for anyone. Nurses should watch patients who become particularly angry and frustrated at that time, since such anger could be a sign of intolerable anxiety that can lead to PTSD. Another interesting fact is that some oncology patients who have undergone surgery followed by postoperative delirium may be at increased risk of developing PTSD as much as 3 months after their surgery. Those who were afraid they would die or experience a postsurgery cognitive decline are at highest risk.2 The clinical signs of PTSD for nurses to watch for include the strong negative emotions described above. Patients may avoid stressful situations or procedures so often that they become socially withdrawn. They may also have unusually strong negative reactions to clinical situations, have difficulty making treatment decisions because they are afraid of making the wrong decision, or may ruminate excessively, which can lead to depression. Patients who witnessed someone close to them endure the difficult side effects of conventional cancer treatments may choose alternative treatments for themselves.2 Continues on page 26

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FEATURE | Adverse Effect Management THE ADVANTAGES OF A GOOD RELATIONSHIP The frequency with which nurses see their patients often facilitates a close relationship. Patients feel comfortable discussing their concerns with the nurse who cares for them, and this presents an opportunity for the nurse to assess the patient psychosocially and intervene as she or he sees fit. For example, a nurse could correct patients’ negative thinking by gradually steering patients who think “I am worthless and a burden” toward more positive thoughts such as “I am lucky that I have a supportive family by my side ….”2

A valuable skill nurses can develop is focused therapeutic communication, which can help them recognize and validate their patients’ concerns.

can teach their oncology patients. Of course, nurses should discuss the option of professional help with patients whose PTSD is becoming difficult to manage. A CAVEAT FOR NURSES The stress of coping with cancer-related PTSD does not stop with patients and their loved ones. Oncology nurses’ roles are ideal for helping their patients with unidentified and untreated cancer-related PTSD; unfortunately, it also puts nurses at risk for compassion fatigue. Hospitals should recognize this, and nursing management should see that support is provided as necessary so nurses can continue working in this important capacity. ■ Bette Weinstein Kaplan is a medical writer based in Tenafly, New Jersey. REFERENCES 1. Leano A, Korman MB, Goldberg L, Ellis J. Are we missing PTSD in our

Other ways nurses can help their patients with PTSD include staying in touch with their patients while encouraging them to take an active role in their treatment. A valuable skill nurses can develop is focused therapeutic communication, which can help them recognize and validate their patients’ concerns and improve their ability to explain to patients and their loved ones that traumatic events may cause distress but can be lessened instead of exacerbated. Meditation and deep breathing exercises are also important practices nurses

Financial Toxicity Continued from page 14

patients with cancer? Part I. Can Oncol Nurs J. 2019;29(2):141-146. 2. Korman MB, Hejri-Rad Y, Goldberg L, Leano A, Ellis J. Oncology nursing role in cancer-related PTSD-Part II. Can Oncol Nurs J. 2019;29(2):147-150. 3. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR). Washington, DC: American Psychiatric Association Publishing; 2000. 4. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Washington, DC: American Psychiatric Association Publishing; 2013.

responses to price disclosure in direct-to-consumer pharmaceutical advertising. JAMA Intern Med. 2019;179(3):435-437. 18. Howard J. Trump’s effort to put drug prices in ads now in limbo. CNN.

13. Bradham DD, Garcia D, Galván A, Erb C. Cost-of-care conversations during clinical visits in federally qualified health centers: an observational study. Ann Intern Med. 2019;170(9_Supplement):S87-S92. 14. Simmons-Duffin S. Will displaying drug list prices in ads help lower costs? NPR; May 8, 2019. https://www.npr.org/sections/healthshots/2019/05/08/721574626/will-displaying-drug-list-prices-in-adshelp-lower-costs. Accessed July 31, 2019. 15. Miller J. Experts divided regarding impact from Trump’s plan to put drug prices in TV ads. Healio Primary Care; May 29, 2019. https://www.healio.

https://www.cnn.com/2019/07/09/health/trump-drug-pricing-ads/ index.html. Updated July 9, 2019. Accessed September 27, 2019. 19. Alexander GC, Casalino LP, Tseng CW, McFadden D, Meltzer DO. Barriers to patient-physician communication about out-of- pocket costs. J Gen Intern Med. 2004;19(8):856-860. 20. Lei YY, Quain KM, Dizon DS, et al. Desire to address costs at time of treatment decisions among patients with metastatic breast cancer. J Clin Oncol. 2019;37(suppl):abstr 6640 21. Pisu M, Schoenberger YM, Herbey I, et al. Perspectives on con-

com/primary-care/practice-management/news/online/{d9681cbb-da4a-

versations about costs of cancer care of breast cancer survi-

4743-ac31-9b180ca9e0a6}/experts-divided-regarding-impact-from-

vors and cancer center staff: a qualitative study. Ann Intern Med.

trumps-plan-to-put-drug-prices-in-tv-ads. Accessed September 27 ,2019.

2019;170(9_Supplement):S54-S61.

16. Thomas K. Drug makers sue to block requirement for listing prices in TV

22. Mader K, Sammen JM, Klene C, et al. Community-designed mes-

ads. New York Times; June 14, 2019. https://www.nytimes.com/2019/

saging interventions to improve cost-of-care conversations in

06/14/health/drug-prices-tv-ads.html. Accessed September 27, 2019.

settings serving low-income, Latino populations. Ann Intern Med.

17. Garrett JB, Tayler WB, Bai G, Socal MP, Trujillo AJ, Anderson GF. Consumer

2019;170(9_Supplement):S79-S86.

26 ONCOLOGY NURSE ADVISOR • SEPTEMBER/OCTOBER 2019 • www.OncologyNurseAdvisor.com

COMMUNICATION CHALLENGES

A Longing for What Will Be Missed Ann J. Brady, MSN, RN-BC, CHPN

children grow up, walking a daughter down the aisle, holding a first grandchild. The future is challenged and changed by their diagnosis. And profound grief accompanies that realization. If only, what if, I want a do over.

Fernweh. It is a German word, quite unique; it roughly translates as having a longing for a place you have never been.

heard about it on a news radio program. Fernweh. It is a German word, quite unique and without an exact translation; but it roughly translates as having a longing for a place you have never been. As opposed to homesickness, which is to miss the place you came from, this is about missing a place where you have not been. Nearly the opposite of déjà vu, which is to have a feeling of having been somewhere before; in this case, it is a sense of belonging somewhere you have never been. The longing comes from realizing you will never get there. The literal translation of fernweh is farsickness, having almost gotten to a place and missing it. Most of our patients surely must experience this feeling. Their diagnosis means they will never get to where they’d thought they would. The place they always assumed they would go to is suddenly altered. Whether it was a plan for what life would look like in retirement, future travel, the luxury of good health, or other concrete longings, eg, seeing

CASE In a family meeting I was in just today, our physician asked Joe, a patient with an advanced lung cancer, what he understood about his disease. His response was simple and blunt. “I understand that I’m screwed. That there is no way out of this.” He was silent for a moment before adding, “I feel like I’ve been locked away in prison even though I did nothing wrong. And they threw the key away, and there is nothing for me to do.” He paused then, “I had so many plans.” That, I believe, is fernweh. The next thing that happened was not unusual. His sister shook her head and said, “Don’t say that. It’s not true. There is always a chance, a miracle, or a new chemo.” He didn’t respond, neither agreeing nor disagreeing. He looked at her without malice or anger, but with a detached kind of disbelief. If he could acknowledge what he knew was true, why couldn’t she? This is not uncommon; someone close tries to convince the patient that they can’t give up. All they need do is stay strong, physically and mentally, and to fight. Sometimes we caregivers may do something similar. Our own discomfort can be a barrier. Do I want to be the one to agree that, as my patient said, he is screwed? We worry about taking hope away, and we say what we know is not true, albeit a modified version. We say what we are more comfortable saying. We may even try to convince them not

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COMMUNICATION CHALLENGES

But after the diagnosis, the shimmering horizon turns out to be a mirage, the desert heat tricking their minds. What they want is what they thought they had coming.

to long for what they will miss, and instead to be grateful for what they have. Which is true and vital. But the altered future is not what they had imagined. If you ask most people how they would like to die, they have a picture of peacefully dying in their sleep. If you ask how they envision their life prediagnosis, it is wide open, an endless road with a shimmering horizon. But after the diagnosis, the shimmering horizon turns out to be a mirage, the desert heat tricking their minds. What they want is what they thought they had coming. DISCUSSION

One communication challenge we may encounter with our patients, regardless of the stage or progression of their disease, is their whisper of longing for a future now out of reach. What happens to their fernweh? Circumstances and logistics can delay a patient considering their loss of the future. They go from diagnosis to treatment planning, from new doctors to strange scans and tests. Their timeline is plotted out for them: 6 cycles of chemo, 10 weeks of radiotherapy, surgery next week. They become the proverbial deer in headlights. There is no time to think, yet there is no stopping the thoughts. This is fernweh, missing the future, the feeling of where they belonged. Grief, sadness, and depression may all be present. In an effort to help, we may try to “jolly them out of it” or we may ignore it entirely, continuing to provide care as if we never heard what they said. I’m not suggesting we would blatantly ignore a patient, but rather we may fail to

ask for clarification when the patient makes a statement that leaves us uncomfortable. So, what can we do in this situation? The simplest answer is to stay simple. By that I mean not trying to over explain, not working to find the silver lining. Acknowledging their reality is okay. When Joe said he was screwed — a euphemism for the word he actually used — the room went quiet. He had said the most profoundly true statement, and everyone was uncomfortable. His sister told him, said in love yet with obvious discomfort, not to say that. But by doing so she invalidated him. A dozen quick responses raced through my mind as I tried to decide if I should correct the sister, or try to soften the harsh reality he had defined. I settled on the simple truth. “You’re right. You’re screwed.” His sister drew in an uncomfortable breath but listened as I continued. “But you do have some choices. They will not change the final outcome. You will die from your cancer. But you can choose to do more chemo, or you can choose not to. You can choose how and where you want to spend the time you have.” I wasn’t sure if I was right to affirm what he’d said. Because of how crass and adamant he’d been in his declaration, it made me feel like agreeing with him was embracing his darkness. He shook his head and pointed at me. I had a flicker of panic that by agreeing with him I had upset him. Instead he said, “Thank you. Thank you.” He was sad, feeling fernweh, longing for the place where he was meant to go. ■ Ann Brady is a symptom management care coordinator at a cancer center in Pasadena, California.

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ISSUES IN CANCER SURVIVORSHIP © ZBYNEK POSPISIL / GETTY IMAGES

Can Vitamin D Supplements Improve PFS and RFS in Gastrointestinal Cancers? Bette Weinstein Kaplan

he healthcare community has increasingly recognized the important role of vitamin D in numerous medical conditions, from preventing rickets in the young to inhibiting dementia in the elderly.1,2 Recently, 2 trials investigated its effect on cancer. The SUNSHINE Randomized Clinical Trial compared the effect of high-dose vs standarddose vitamin D3 supplementation on progression-free survival (PFS) among patients with advanced or metastatic colorectal cancer3; the AMATERASU Randomized Clinical Trial investigated the effect of vitamin D supplementation on relapse-free survival (RFS) among patients with digestive tract cancers.4 IS HIGH-DOSE BETTER? A number of studies have demonstrated the beneficial effects of plasma 25-hydroxyvitamin D (25[OH]D), which is the most reliable indicator of vitamin D status, for patients with cancer. For example, high levels of vitamin D were associated with a decreased risk of developing colorectal cancer, and a better chance of survival among patients who already had the disease.3 The SUNSHINE trial, a double-blind, multicenter, phase 2 randomized clinical trial conducted in several cancer centers throughout the United States, sought to further explore these effects. The trial was designed specifically to evaluate the

efficacy of high-dose vitamin D3 compared with standard-dose vitamin D3 when given in combination with conventional chemotherapy. The researchers sought to find out whether raising plasma 25(OH)D levels in patients with metastatic colorectal cancer who were receiving chemotherapy was feasible. Chemotherapy A total of 139 patients were enrolled in the trial. All patients were treated with oxaliplatin 85 mg/ m2, leucovorin 400 mg/m2, and 5-fluorouracil (5-FU) 400 mg/m2 bolus then 2400 mg/m2 IV continuous infusion over 46 to 48 hours (mFOLFOX6) plus bevacizumab 5 mg/kg IV every 14-day cycle. At the investigator’s discretion, bevacizumab could be omitted during the first cycle and started with the second.3 Vitamin D Patients were randomized to receive high-dose vitamin D3 (69 patients) or standard-dose vitamin D3 (70 patients). The high-dose group received a loading dose of 8000 IU/day for cycle 1, followed by 4000 IU/day for subsequent cycles. The standard-dose group received 400 IU/day of vitamin D3 during all cycles.3 Median plasma 25(OH)D levels were deficient in both groups at baseline. In fact, only 9% of all participants had sufficient levels (30 ng/mL or higher) at baseline. At the trial’s end, only the patients in the high-dose vitamin D group

had sufficient levels of vitamin D3 (34.8 ng/mL), whereas vitamin D levels were still deficient, with a median 25(OH)D level of 18.7 ng/mL in the standard-dose group. Progression-free survival is a surrogate for overall survival in trials of metastatic colorectal cancer.5 In this trial, it was the primary end point, defined as from when patients first received chemotherapy and vitamin D3 until their first occurrence of disease progression or death. Results Median PFS rates were not statistically different between the 2 groups. However, high-dose vitamin D3 had a greater effect on PFS among those patients who had a lower body mass index, more metastases, and KRAS wild-type tumors. The most common reported adverse events included neutropenia (24 patients [35%] in the high-dose group vs 21 patients [31%] in the standard-dose group), hypertension (9 patients vs 11 patients, respectively), and diarrhea (1 patient vs 8 patients, respectively). Two patients died during the trial; however, the deaths were unrelated to vitamin D3. Tumor objective response rate and overall survival were not statistically different between the 2 groups, concluded the researchers. However, high-dose vitamin D3 supplementation increased median plasma 25(OH)D

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ISSUES IN CANCER SURVIVORSHIP levels into the sufficient range, whereas levels remained unchanged with standard-dose vitamin D3 supplements. INHIBITING DISEASE RELAPSE The AMATERASU Randomized Clinical Trial is a randomized, doubleblind, placebo-controlled trial conducted at the International University of Health and Welfare Hospital in Ohtawara, Japan. The purpose of the study was to evaluate whether use of vitamin D3 supplements could improve survival rates for patients with stage I-III digestive tract epithelial carcinoma after surgical resection from the esophagus, stomach, small intestine, colon, or rectum. The trial enrolled 417 patients aged 30 to 90 years (mean age, 66); 66% were men; patients had esophageal cancer (10%), gastric cancer (42%), or colorectal cancer (48%). Patients were

5-year RFS was 77% in the vitamin D group and 69% in the placebo group. included if they met the histopathological criteria, were not already taking vitamin D supplements, and had no history of urinary tract calculi. Enrollment occurred at their first postsurgical visit to the outpatient clinic. At that point, they were randomly assigned to take a vitamin D3 supplement of 2000 IU every day or placebo. Participants were

instructed to take the trial medication daily until the end of the trial.4 Primary outcome was relapse-free survival from the first day of taking the study medication until cancer relapse or death from any cause. Secondary outcome was overall survival time to death from cancer or death from any cause. Chemotherapy Patients with stage II or stage III esophageal cancer received chemotherapy. Patients with stage II or III gastric cancer received postoperative chemotherapy, as did all patients with stage III colorectal cancer.

survival was 77% for patients in the vitamin D group and 69% for those in the placebo group. The difference is not statistically significant. Ba sed on t he se re su lt s, t he AMATERASU researchers concluded that vitamin D supplementation, compared with placebo, did not result in significant improvement in relapse-free survival at 5 years among patients with digestive tract cancers. ■ Bette Weinstein Kaplan is a medical writer based in Tenafly, New Jersey. REFERENCES

Vitamin D Radioimmunoassay was used

to measure serum levels of 25(OH)D after the study participants began taking the supplements. Trial subgroups had baseline serum 25(OH)D levels of 0 to less than 20 ng/mL, 20 to 40 ng/mL, and more than 40 ng/mL. The researchers only assessed interactions between the low and middle level baseline groups. For this long-term study, participants were assessed for any cancer relapse with CT and PET scans, MRIs, and other interventions every month for the first 6 months, every 2 months for the second 6 months, and every 3 months after that for 5 years. The surgeon in charge determined follow-ups after 5 years.4

1. Lautatzis ME, Sharma A, Rodd C. A closer look at rickets and vitamin D deficiency in Manitoba: the tip of the iceberg. Paediatr Child Health. 2019;24(3):179-184. 2. Miller JW, Harvey DJ, Beckett LA, et al. Vitamin D status and rates of cognitive decline in a multiethnic cohort of older adults. JAMA Neurol. 2015;72(11):1295-1303. 3. Ng K, Nimeiri HS, McCleary NJ, et al. Effect of high-dose vs standard-dose vitamin D3 supplementation on progression-free survival among patients with advanced or metastatic colorectal cancer: the SUNSHINE Randomized Clinical Trial. JAMA. 2019;321(14):1370-1379. 4. Urashima M, Ohdaira H, Akutsu T, et al. Effect of vitamin D supplementation on relapsefree survival among patients with digestive

Results Vitamin D supplementation did

not lead to an improvement in relapsefree survival. Twenty percent of those taking vitamin D and 26% of those taking placebo experienced disease relapse or died. Five-year relapse-free

tract cancers: the AMATERASU randomized clinical trial. JAMA. 2019;321(14):1361-1369. 5. Cicero G, De Luca R, Dieli F. Progression-free survival as a surrogate endpoint of overall survival in patients with metastatic colorectal cancer. Onco Targets Ther. 2018;11:3059-3063.

Let us answer your questions!

E-mail us at editor.ona@haymarketmedia.com with your general questions for our expert Advisor Forum and your drug-related questions for Ask a Pharmacist! 30 ONCOLOGY NURSE ADVISOR • SEPTEMBER/OCTOBER 2019 • www.OncologyNurseAdvisor.com

THE TOTAL PATIENT

How Effective Are Popular Palliative Care Interventions for Patients With Cancer? Bette Weinstein Kaplan

VARIED INTEREST IN PALLIATIVE MODALITIES

treatments.1 The 21-country European Social Survey found that the popularity of complementary therapies varied by country. For example, only 10% of patients in Hungary received such treatment, whereas in Germany, almost 40% utilized complementary therapies. People who had health problems utilized complementary therapies 2 to 4 times more often than healthy people.3 The manual body-based therapies that involve the touch of a therapist — massage, aromatherapy, and reflexology — are the most popular, so the UK group decided to focus on those in their recent review. Study participants were aged 18 years or older; at least half of them were in hospice, another palliative care situation, or undergoing treatment for advanced disease with palliative intent. Participants had also participated in discussions about how effective they found modalities such as aromatherapy, massage, or reflexology.1 The UK group searched databases in The Cochrane Controlled Register of Trials using variations of the terms palliative, aromatherapy, reflexology, and massage.

Of course, traditional and complementary therapies are not exclusive of one another. For example, palliative care patients often find their pain reduced and their mood boosted by noncontact therapies such as music therapy while they undergo conventional

THE MOST POPULAR THERAPIES The researchers identified five relevant qualitative studies: 3 investigated massage, 1 investigated reflexology, and 1 investigated aromatherapy. The study cohort included 83 participants, 70 were

re palliative care interventions effective in people coping with advanced cancer? A group of palliative care specialists in the United Kingdom sought to find out. They knew that the anxiety and depression that oncologists often associate with advanced disease can result from the serious issues these patients are dealing with, such as living with relentless pain, anticipating their approaching mortality, and leaving behind the people they love. According to the World Health Organization, the goal of palliative care should be to enhance quality of life while easing the pain cancer patients experience.1 Unfortunately, this cannot always be accomplished with medication and other conventional interventions. In fact, in a 2014 UK survey, palliative care specialists reported that they had difficulty managing their patients’ anxiety.2 For these reasons, the British group decided to “explore other avenues that may improve well-being and symptoms in a palliative care population.”1

female, and all had advanced cancer. Three studies were from Sweden and 2 from the United Kingdom. Treatment settings were hospices, nursing homes, the patients’ homes, and an oncology ward. Nurses and a reflexologist provided the complementary therapies along with authors of the studies who were trained in complementary therapy. Most of the data was collected through one-on-one interviews; one study used focus groups and one used self-reported questionnaires. EXPERIENCES DURING COMPLEMENTARY THERAPY

The participants overwhelmingly reported deriving positive effects on their well-being from the complementary therapy. The interventions were described as calming and relaxing, leaving participants feeling healthier with less negativity and fewer physical symptoms.1 Participants in 4 of the studies reported feeling empowered, whole, important, special, dignified, and good about themselves. Participants in 3 of the studies described feeling a sense of floating away and experiencing an awakening. They felt that the complementary therapy relieved their anxiety, allowing them to focus on the present. They had a feeling of escapism from their disease and an impression of inner peace.1 All the participants found the therapy to be a positive and pleasurable

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THE TOTAL PATIENT

The complementary therapy was thought of as an escape from disease and anxiety. experience. They enjoyed the physical touching. They felt it was “luxurious.” One participant noted that it felt like a reward for enduring such an illness. All of them liked the interactions with their therapists, which was one reason they kept returning for treatments. They could talk comfortably with the therapist in a relaxed setting.

The complementary therapy was thought of as an escape from disease and anxiety that often gave them hope for the future. Participants felt that each session built on the previous one, and they benefitted from the cumulative effect. The researchers call for future trials of complementary therapy in palliative care to identify the ideal methods and to reflect patients’ wishes. ■

massage and reflexology: a systematic review and thematic synthesis of the perspectives from people with palliative care needs. Palliat Med. 2019;33(7): 757-769. 2. Atkin N, Vickerstaff V, Candy B. ‘Worried to death’: the assessment and management of anxiety in patients with advanced life-limiting disease, a national survey of palliative medicine physicians. BMC Palliat Care. 2017;16(1):69.

Bette Weinstein Kaplan is a medical writer based in Tenafly, New Jersey.

3. Kemppainen LM, Kemppainen TT, Reippainen JA, Salmenniemi ST, Vuolanto PH. Use of complementary and alternative

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P, Wilkinson S, Candy B. Aromatherapy,

Public Health. 2018;46(4):448-455.

Time-saving clinical tools for patient-centered care. OncologyNurseAdvisor.com provides all of the tools you need to better care for your patients. • Cancer treatment regimens • Downloadable patient fact sheets

• Easy-to-use medical calculators • Comprehensive drug slideshows

Visit www.OncologyNurseAdvisor.com today. 32 ONCOLOGY NURSE ADVISOR • SEPTEMBER/OCTOBER 2019 • www.OncologyNurseAdvisor.com

RADIATION & YOUR PATIENT

QOL Outcomes With HRT for Prostate Cancer Not Inferior to CRT Bryant Furlow Hypofractionated radiotherapy (HRT) offers quality-of-life (QOL) outcomes similar to that offered by conventional radiation therapy (CRT) for men with low-risk prostate cancer, according to recently published results of a phase 3 randomized study. Hypofractionated radiotherapy offers a less expensive and more convenient treatment option for some patients, and in light of the new findings about QOL, should be considered a practice standard for patients with low-risk prostate cancer, the researchers argued. Oncology nurses and nurse navigators should explain the significance of these study findings when educating patients about treatment options.

ypofractionated radiotherapy is noninferior to CRT for quality-of-life outcomes among men with low-risk prostate tumors, according to an analysis of data from the phase 3 randomized NRG Oncology RTOG 0415 clinical trial, conducted in the United States, Canada, and Switzerland (ClinicalTrials.gov Identifier: NCT00331773).1 “This study provides evidence to affirm that HRT is a practice standard for men with low-risk prostate cancer,” the researchers wrote. “Treatment with HRT is noninferior to CRT in men with low-risk prostate cancer in terms of disease-free survival and, as shown in the present study, in prostate cancer-specific (bowel, bladder, sexual) and general quality of life, as well as in anxiety and depression.” Previous research has shown that among men with prostate cancer, subjective study outcomes such as sexual function, anxiety, depression, diarrhea, and bloating were “more reflective of the patient experience” than Common Terminology Criteria for Adverse Events (CTCAEs) outcomes.1 RTOG 0415 was a noninferiority radiotherapy trial. Of 1092 men initially enrolled in the trial, 542 were randomly assigned to receive CRT and 550 were assigned to receive HRT. At a median follow-up of 5.8 years, 5-year diseasefree survival was 85.3% for conventional radiotherapy (73.8 Gy in 41 fractions over 8 weeks) and 86.3% for HRT (70 Gy in 28 fractions over 5.6 weeks).1 But before practice standards can be revised, “it is important to demonstrate that not only is tumor control and disease-free survival noninferior, but also that quality of life is not diminished by a shorter fractionation schedule with a higher dose per treatment session,” the researchers noted.1

Physician-reported grade 2 and 3 gastrointestinal and genitourinary CTCAEs were previously reported to have been modestly elevated among men in the HRT arm of the RTOG 0415 trial, compared with those receiving conventional radiotherapy (relative risk, 1.59; 95% CI, 1.22-2.06; P =.002).1 The newly reported analysis examined RTOG 0415 data for the 962 men (mean age, 66.6 years) who had consented to participate in the quality of life component of the study: 478 from the CRT arm and 484 from the HRT arm. Quality of life was assessed at baseline and 6, 12, 24, and 60 months, using 3 questionnaires: the Expanded Prostate Index Composite questionnaire for bowel, urinary, sexual, and hormonal outcomes; the Hopkins Symptom Checklist for anxiety and depression outcomes; and the EuroQol-5 Dimension questionnaire for global quality of life. At baseline, the authors found no statistically significant differences between study groups for patient characteristics or quality-of-life scores. “There were no differences in change score between arms with respect to any of the Expanded Prostate Index Composite questionnaire domain scores,” the researchers reported.1 And, no differences were observed between study arms for the Hopkins Symptom Checklist and EuroQol–5 Dimension questionnaire scores. The researchers observed no difference in patient-reported urinary symptom scores between those who underwent HRT and those who underwent CRT. “There were also no differences in patient-reported bowel symptom scores between arms at 6, 24, or 60 months,” they reported.1 At 12 months, men in the HRT group saw a larger decline in bowel outcomes Continues on page 35

www.OncologyNurseAdvisor.com • SEPTEMBER/OCTOBER 2019 • ONCOLOGY NURSE ADVISOR 33

FROM

ancer is the leading cause of death for Hispanics in the United States. Although Hispanics make up 18% of the total US population, they account for 21% of cancer-related deaths.1 Hispanics are more likely to have later-stage disease at the time of diagnosis and are more likely to experience poorer health outcomes, even after diagnosis. A number of different factors account for the disparity. Almost 23% of Hispanics in the United States live below the poverty level, compared with less than 11% of non-Hispanic whites. A greater percentage of Hispanics are uninsured or underinsured than are nonHispanic whites. Language, education, acculturation, and immigration status all affect access to services for Hispanics.1,2 Providing culturally competent care to patients can greatly facilitate rapport and reduce patients’ stress and uncertainty, while increasing treatment compliance.3 Although the Hispanic community is large and diverse, there are some characteristics that can be applied generally. To navigate the common roadblocks to a successful relationship with your Hispanic patients, consider the following: Language If your patient is not a native English speaker, there is a higher probability of misunderstanding and confusion. In the midst of hearing about diagnosis or treatment protocol, every patient, regardless of language, can become overwhelmed, confused, or forgetful. When English is not their native language, patients may struggle to understand content and meaning.

How to Build a Successful Relationship With Hispanic Patients Lucia Fanjul, MSW, LMSW

patient to make sure the information provided was clearly understood. Maria, a client in CancerCare’s Spanish-speaking women support group, shared that she stopped taking her hormonal treatment because it made her feel not herself. Maria said the doctor told her it would be a good idea to take the medication. She understood that to mean it was optional. When she started experiencing side effects, Maria decided to stop the medication. After her peers urged her to talk to the nurse at her office, Maria was able to understand more about the treatment. Thanks to her nurse interpreting and advocating for her, Maria received a different prescription, which she tolerated better. Family Culturally, life in the Hispanic

community revolves around the family unit, with the community prioritizing the group over an individual person. A person’s wellbeing is the responsibility of the family, which usually includes extended family members and longtime friends. Several generations of one family living under the same roof is not uncommon. Understanding this different definition of family will allow for participation from any involved caregiver, regardless of blood relation, and help the patient trust and feel confidence in the medical team. There are 20 Spanish speaking countries in Latin America and each has its own variation in the meaning of certain words and slang, so even when 2 Spanish speakers are communicating, they may need to clarify certain meanings. Whenever possible, check in with an interpreter, a family member, or the

Authority Hispanics can defer to anyone in a position of authority, especially doctors or nurses. Patients might be hesitant to ask questions, raise concerns, or act as a strong advocate on their own behalf while discussing diagnosis and treatment plans. Taking the time to review the information to ensure the patient

Providing culturally competent care to patients can facilitate rapport and reduce patients’ stress and uncertainty. 34 ONCOLOGY NURSE ADVISOR • SEPTEMBER/OCTOBER 2019 • www.OncologyNurseAdvisor.com

understands will help to ensure adherence to any treatment plan. Similarly, older Hispanic people can be considered authorities in the community and must be addressed in a formal way by using appropriate titles and their last name.

Culturally, life in the Hispanic community revolves around the family unit. Religion The majority of the Hispanic

population identifies as Christian and religion plays an important role in the community. Praying, attending Mass, receiving support from a priest, and believing in miracles is a main source of comfort and support. Religion is a way of coping for the community, particularly among older generations. Understanding this and allowing

Radiation Continued from page 33

than those in the CRT group (mean score, −7.5 vs −3.7, a mean 3.8-point greater decline for bowel symptoms; P <.001).1 But the difference did not reach the study’s predesignated threshold for clinical significance. “Clinical significance is an important metric when assessing the issue of interpretability of patient-reported outcomes,” they noted. “It helps us understand what changes in scores correspond to small, moderate, or large patient benefit or decrement. For example, if a person improves by 5 points on a 100- point scale on sexual function, will he be more satisfied with his sexual

religion to be part of the conversation will allow for a stronger relationship. Navigating a cancer diagnosis and treatment is overwhelming for the patient and the family members on many levels. Meeting new doctors, specialists, testing appointments, follow-ups and receiving treatment can feel devastating and even unbearable. Doctors are not always available for long conversations or detailed explanations, so nurses have always stepped in to fill that gap. Oncology nurses, in particular, are an essential support for patients navigating a highstress and terrifying reality. Nurses can provide an empathetic, competent, and comforting experience for patients in an oncology setting. Understanding patients in a cultural context will help improve the Hispanic patient’s experience. For our support group member, Maria, clearer instructions from the doctor might have helped her understand the need to continue her treatment and the expected side effects. A culturally aware

conversation with the oncology nurse, someone who Maria might have found more approachable, would have helped her make an educated decision about her treatment and likely ensured better treatment compliance. ■

experiences or perceived as having better sexual function by his partner? In this context, the present study shows that the single time point the bowel score was statistically significantly worse in the HRT arm was of small consequence as perceived by the patient.” The researchers cautioned that the study did not specify a predetermined single time point for the primary quality of life EPIC end point.1 “Therapy that has no more adverse events for a course of 5.6 weeks compared with 8.2 weeks would have obvious implications for patient decision making and resource savings,” the researchers reported. “It should be noted that most patients who qualified for this trial would also be eligible for

active surveillance, and thus better quality of life than radiotherapy or surgery, yet many men choose treatment.” Given the study’s findings regarding quality of life outcomes and noting an estimated $7700 cost saving per patient treated with HRT instead of CRT, there should be “no deterrents to its adoption,” they concluded. ■

Lucia Fanjul is an oncology social worker at CancerCare. REFERENCES 1. Yanez B, McGinty HL, Buitrago D, Ramirez AG, Penedo FJ. Cancer outcomes in Hispanics/ Latinos in the United States: an integrative review of conceptual model of determinants of health. J Lat Psychol. 2016;4(2):114-129. 2. Escarce JJ, Kapur K. Access to and quality of health care. In: National Research Council (US) Panel on Hispanics in the United States; Tienda M, Mitchell F, eds. Hispanics and the Future of America. Washington, DC: National Academies Press; 2006. 3. Flowers DL. Culturally competent nursing care: a challenge for the 21st century. Crit Care Nurse. 2004;24(4):48-52.

Bryant Furlow is a medical journalist based in Albuquerque, New Mexico. REFERENCE 1. Bruner DW, Pugh SL, Lee WR, et al. Quality of life in patients with low-risk prostate cancer treated with hypofractionated vs conventional radiotherapy: a phase 3 randomized clinical trial. JAMA Oncology. 2019;5(5):664-670.

www.OncologyNurseAdvisor.com • SEPTEMBER/OCTOBER 2019 • ONCOLOGY NURSE ADVISOR 35

ASK A PHARMACIST

FDA Recall of Several ARBs; Options for Safe Disposal of Drugs Some of my patients are worried about the headlines about blood pressure medicines containing carcinogens. How should I advise them?

list of chemicals that are suspected to cause cancer in humans after a certain amount of exposure. A few things to emphasize to patients include: • Not all batches of these ARB medicines are affected by this, so patients may be able to continue their therapy while avoiding the batches that are affected. • Very serious, even life-threatening, risks are associated with suddenly stopping a blood pressure medicine. Patients who are not able to fill their ARB or who would like to avoid these drugs altogether should speak with their doctor and pharmacist about alternative medicines to treat their blood pressure before stopping their ARB. • If patients have medicine that is affected by the recall or are worried their ARB may be included, they should check with the pharmacist who dispensed the medicine. • Although hearing about recalls is alarming, they indicate that the Food & Drug Administration (FDA)’s processes to ensure the purity of medicines are working. The FDA is working with drug manufacturers to recall batches of drugs containing these compounds and to ensure the compounds are not present in future batches.

— Name withheld on request

Some angiotensin II receptor blocker (ARB) products, including valsartan, losartan, and irbesartan, were recalled this year due to the presence of nitrosamine impurities in the final product. Hearing this can be extremely concerning for patients, regardless of whether they also have a cancer diagnosis. The nitrosamine compounds are thought to have been inadvertently generated during the manufacturing process. These compounds are on a

For more information from the FDA on this subject, visit “More Questions and Answers: Impurities Found in Certain Angiotensin II

Receptor Blocker (ARB) Products.” The American Heart Association also has some information available on their website (“Q&A High Blood Pressure Medication Recall”). How and where can patients and caregivers dispose unused medications safely? — Name withheld on request

DEA Drug Take Back Day The Drug Enforcement Agency (DEA) Drug Take Back Day is a national event coordinated with community partners and local law enforcement officials to provide an opportunity for patients and caregivers to dispose of unused medications. The next DEA Drug Take Back Day is Saturday, October 26, 2019. Information on locations and other drug disposal opportunities is available on the DEA website (https://takeback day.dea.gov/). Year Round Drug Disposal Locator Tool

Another helpful tool is the National Association of Boards of Pharmacy (NABP) AWARxE Prescription Drug Safety Program Drug Disposal Locator Tool (https://safe.pharmacy/drug-disposal/). The tool contains links to more than 7000 drug disposal locations. Both law enforcement sites and pharmacy locations are included. Of note, this tool only includes permanent drug disposal sites. ■

Lisa A. Thompson, PharmD, BCOP Clinical Pharmacy Specialist in Oncology Kaiser Permanente, Colorado

36 ONCOLOGY NURSE ADVISOR • SEPTEMBER/OCTOBER 2019 • www.OncologyNurseAdvisor.com