Oncology Nurse Advisor September/October 2020

www.OncologyNurseAdvisor.com

September/October 2020

SPECIAL EDITION

Navigation Strategies for Health Insurance, CAR-T Therapy, and Breast Cancer IN THE NEWS

Effects of GNRI on Outcomes of CRC Surgery … and more

ONCOLOGY NAVIGATION

Navigation 101: A Primer on an Expanding Role in Cancer Care

NAVIGATION NOTES PRSRT STD US POSTAGE PAID PONTIAC IL PERMIT #60

Influence of Social Determinants of Health on Health Equity

PUBLISHING STAFF

ADVERTISING STAFF

Editor Joyce Pagán editor.ona@haymarketmedia.com

Vice president, Oncology business development Henry Amato (646) 638-6096 henry.amato@haymarketmedia.com

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

BUSINESS STAFF Vice president, Sales Operations & Production Louise Morrin Boyle

Director, Oncology business development & strategy Marc A. DiBartolomeo (609) 417-0628 marc.dibartolomeo@haymarketmedia.com Associate account manager Kate O’Shea (646) 638-6028 kate.oshea@haymarketmedia.com

HAYMARKET MEDIA Editorial director, Haymarket Oncology Lauren Burke Vice president, 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

Production manager Brian Wask brian.wask@haymarketmedia.com

President, Medical Communications Michael Graziani

Director of Audience Insights Paul Silver

CEO, Haymarket Media Inc Lee Maniscalco

Haymarket Media Inc Sales and Editorial offices 275 7th Avenue, 10th Floor, New York, NY 10001; (646) 638-6000 Subscriptions: www.OncologyNurseAdvisor.com/freesub Reprints: For reprints/licensing, contact Customer Service at custserv@haymarketmedia.com Permissions: https://www.copyright.com/get-permissions/ Unless otherwise indicated, persons appearing in photographs are not the actual individuals mentioned in the articles. They appear for illustrative purposes only.

Oncology Nurse Advisor (ISSN 2154-350X), September/October 2020, Volume 11, Number 4. 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 © 2020.

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.

4 ONCOLOGY NURSE ADVISOR • SEPTEMBER/OCTOBER 2020 • www.OncologyNurseAdvisor.com

CONTENTS 14

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September/October 2020

IN THE NEWS • Geriatric Nutritional Risk Index Predictive of Outcomes Following CRC Surgery • Patient-Reported Outcomes With Chemoradiation Therapy for the Treatment of Anal Cancer • Systemic Antibacterial Prophylaxis Not Recommended in All Pediatric Intensive Chemotherapy or HSCT

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• Promising Early Results for Use of Teriparatide in the Treatment of MRONJ • MPN Genomic Calculator Performs Well in Real-Life Cohort of Patients With ET • Reducing Time to Alkalinization Prior to HD-MTX Does Not Reduce Hospital Length of Stay

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• Hearing Loss Associated With Neurocognitive Deficits in Pediatric Cancer Survivors • Restructured Process Overcomes Barriers to Prior Authorization for Proton Therapy • Rapid Third-Infusion Protocol of Daratumumab in Patients With RRMM

23 FIND US ON

• Frailty Linked to Poor Postsurgical Outcomes in Patients With Ovarian Cancer

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www.OncologyNurseAdvisor.com • SEPTEMBER/OCTOBER 2020 • ONCOLOGY NURSE ADVISOR 5

JOURNAL REVIEW NCCN Recommended Best Practices for Keeping Patients and Nurses Safe During COVID-19 Pandemic

CONTENTS

September/October 2020

The National Comprehensive Cancer Network offers guidelines designed to protect patients and nurses while continuing needed cancer care during the COVID-19 pandemic.

John Schieszer, MA

SPECIAL EDITION: ONCOLOGY NAVIGATION 19

Navigation 101 Deborah Christensen, MSN, APRN, AOCN, OCN; Judy Koutlas, RN, MS, OCN

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Long-Term Aesthetic Outcomes of Breast Implants Shown to Be Stable, Study Shows

A review and update on the role of the oncology nurse navigator, including a discussion of the 4 main categories of the ONS Oncology Nurse Navigator Competencies and how they define the role and tasks of both novic and expert navigators.

Retrospective study demonstrates that outcomes of 2-stage breast reconstruction are stable over the long term, with high patient and surgeon satisfaction.

Navigating Health Insurance for Patients With Cancer

FROM CANCERCARE

Joyce Pagán

Cancer and Fibromyalgia: Addressing the Needs of Patients Despite Limited Research

A cancer rights attorney and CEO of a national, nonprofit organization connecting people to cancer survivorship education explains the basics of health insurance options available to patients with cancer who do not have employer-sponsored health insurance.

22

ISSUES IN CANCER SURVIVORSHIP

Navigation Strategies for Chimeric Antigen Receptor T-Cell (CAR-T) Therapy and Hematologic Cancers

Bette Weinstein Kaplan

In addition to being common yet serious diseases, both cancer and fibromyalgia bring a high burden of physical pain and negative effects on mental health.

Mary Hanley, LMSW

Erin Mullane, FNP-C, DNP, BSN; Katie M. Gieseke, ARNP, FNP-BC, DNP

An overview of CAR-T therapy with a discussion of the challenges and potential barriers unique to this treatment, solutions for navigating patients through and around these barriers, and posttreatment and long-term survivorship care.

23

Navigation Strategies for Patients With Breast Cancer Debra Mascarenhas, RN, BSN, CBCN

The role of the breast cancer nurse navigator and how it ensures access to screening, timely treatment at early stages of disease, and varied support needs of patients, as well as strategies for managing treatment, adverse effects, and survivorship, are described.

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NAVIGATION NOTES Influence of Social Determinants of Health on Health Equity Janice Phillips, PhD, RN, CENP, FAAN

PUBLISHERS’ ALLIANCE Predicting Lung Cancer Risk of Incidental Solid and Subsolid Pulmonary Nodules in Different Sizes

Based on these study findings, researchers present 4 prediction models developed to determine risk of malignancy in subsolid lung nodules that are 15 mm or smaller and 15 to 30 mm.

Cancer Management and Research

ON THE

WEB

6 ONCOLOGY NURSE ADVISOR • SEPTEMBER/OCTOBER 2020 • www.OncologyNurseAdvisor.com

Write for ONA! Oncology Nurse Advisor offers clinical updates and evidence-based guidance to the oncology nurse community and includes regular coverage of topics such as the safe handling and administration of chemotherapy drugs, side effect management, new developments in specific cancers, palliative care, communication with patients and family, and cancer survivorship.

We welcome contributions from readers in the following categories: Oncology Nurse Advisor Forum: Answers to clinical questions and advice for clinical problems. Readers may submit questions and requests for advice that are 50 to 100 words long. The author should include full name and degrees, name of institution or practice, and city and state.

Feature article: Oncology Nurse Advisor welcomes feature articles on the administration and handling of chemotherapy drugs; side-effect management; communication with patients, families, and colleagues; what’s new in the treatment of specific cancers or cancer-related conditions; survivorship issues; patient navigation; and other topics of interest to oncology nurses. Manuscripts should be 1200 to 2000 words long and should include a brief reference list.

Reflections: These are brief, reflective essays on a topic related to oncology practice or narratives recounting a meaningful experience with a patient. Manuscripts should be 800 to 1200 words long.

Case Study: This department focuses on clinical cases of interest to oncology nurses. Manuscripts should be written in the standard case-followed-by-discussion format and should be 1500 to 2000 words long. A brief reference list may accompany the discussion section. Please include a list of 3 to 5 take-home points (teaching points) for the reader. The PDF template in our Author Guidelines is an easy, step-by-step guide for writing up your Case Study.

Ask a Pharmacist: In this department, our oncology pharmacist answers readers’ drug-related questions. Questions should be 50 to 100 words. The author should include full name and degrees, name of institution or practice, and city and state.

See our author guidelines, available at www.OncologyNurseAdvisor.com/ au-guides, for more details.

IN THE NEWS Geriatric Nutritional Risk Index Predictive of Outcomes Following CRC Surgery A new study suggests that the Geriatric Nutritional Risk Index (GNRI) may be a predictor of complications and overall prognosis for elderly patients following surgery for colorectal cancer (CRC).

The GNRI allocates patients to nutrition-based risk groups using serum albumin level, height, current body weight, and ideal body weight, explained the researchers. For this study, they retrospectively studied 313 patients with CRC who were aged 65 years or older and who underwent curative surgery at the Osaka University Hospital in Osaka, Japan.

The researchers evaluated patient outcomes following surgery after stratifying patients according to GNRI, into either an all-risk group or a no-risk group. The allrisk group had GNRI scores of 98 or lower, with the norisk group having GNRI scores higher than 98.

Patients in this analysis had a median age of 73 years (range, 65 to 94). Stage 0 disease was present in 9.3% of patients, with stage I disease in 36.7%, stage II disease in 24.6%, stage III disease in 26.5%, and stage IV disease in 2.9%. Prior to surgery, the mean GNRI was 98.2.

The median study follow-up occurred at 60.5 months. The overall survival (OS) rate of patients in the all-risk group was significantly poorer than in the no-risk group (P =.009). The 5-year OS rates were 79.6% for the all-risk GNRI group and 86.0% for the no-risk group.

In multivariate analyses, low GNRI was an independent predictor for overall survival (P =.001) and a predictor of postoperative complications (P =.048).

“Preoperative GNRI can be a useful tool to identify high-risk population of morbidity and mortality in elderly patients with CRC,” the researchers concluded in their report.

Patient-Reported Outcomes With Chemoradiation Therapy for the Treatment of Anal Cancer A study of patient-reported outcomes (PROs) in patients undergoing chemoradiation therapy for anal cancer suggests that patients initially experience a worsening of gastrointestinal (GI) symptoms with treatment, but that this worsening typically subsides within a few months of starting treatment.

Patients included in this prospective analysis had nonmetastatic anal squamous cell carcinoma. All patients received definitive chemoradiotherapy (21 patients), and they were

given a survey that consisted of the bowel subdomain of the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. EPIC scores for this subdomain were compared for subjects across timepoints at baseline and at 1 week, 3 weeks, 5 weeks, and 3 months after the start of therapy.

Slightly more than half of patients (52%) showed T2 tumor disease, and 81% of patients had N0 or N1 classification. The most common chemoradiotherapy approach was cisplatin plus fluorouracil with radiation given as intensity-modulated radiotherapy or volumetric modulated arc therapy.

The overall baseline median EPIC score for this population was 66, and at 1 week the median score had shifted to

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Read more at https://bit.ly/ONA1020j

82 (P =.009), signaling a worsening of symptoms. However, at 5 weeks, the median score had dropped to 54 (P =.025).

Overall, from baseline to 3 months, there was not a significant difference in median score (P =.919).

PROs related to GI symptoms for these patients with anal cancer receiving chemoradiotherapy fluctuated, but by 3 months appeared to stabilize to baseline levels.

Read more at https://bit.ly/ONA1020a

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Systemic Antibacterial Prophylaxis Not Recommended in All Pediatric Intensive Chemotherapy or HSCT Following a systematic review of the medical literature, a strong recommendation was made by a multinational, multidisciplinary expert panel against the routine use of systemic antibacterial prophylaxis (SAP) in pediatric patients with cancer and children undergoing hematopoietic stem cell transplantation (HSCT) unless prolonged severe neutropenia is likely to develop.

Although children with cancer undergoing intensive chemotherapy and pediatric recipients of HSCT are at increased risk of bacteremia and other invasive bacterial infections, potential benefits of SAP, such as decreased bacterial infection-related morbidity and mortality, must be weighed against the potential risks of this approach, including the development of antibiotic resistance, an increased likelihood of infection with Clostridioides difficile and fungal pathogens, as well as antibiotic-related toxicities.

The guideline panel noted that “although the data supported administration of a fluoroquinolone if systematic antibacterial prophylaxis is planned, the panel was concerned about reported adverse effects associated with these agents and levofloxacin in particular.”

Moreover, they commented that “patients and families should be informed about potential short- and long-term fluoroquinolone-related adverse effects prior to administration and this information may lead to some families choosing against prophylaxis.”

In addition, related areas representing knowledge gaps identified by the guideline panel as requiring further study included the need to identify subgroups of children with ALL undergoing induction chemotherapy and other children with solid tumors undergoing intensive chemotherapy at increased risk of prolonged, severe neutropenia.

Read more at https://bit.ly/ONA1020e

Promising Early Results for Use of Teriparatide in the Treatment of MRONJ Eight weeks of daily subcutaneous injections of teriparatide, a parathyroid hormone analogue (PTH 1-34), were associated with an increased rate of resolution of medication-related osteonecrosis of the jaw (MRONJ) lesions, according to results of a small, placeboBone volume and controlled study. deficits improved.

Based on limited data suggesting a potential benefit for teriparatide in the treatment of MRONJ, as well as the results of an 8-week study that investigated its use in the setting of chronic peritonitis, teriparatide, an agent that has been approved by the US Food and Drug Administration (FDA) since 1987 for the treatment of patients with osteoporosis, was evaluated in a randomized, placebo-controlled trial of patients with established MRONJ. This study (ACTRN12612000950864) enrolled 34 patients with MRONJ who were randomly assigned in a 1:1 ratio to receive 8 weeks of once-daily subcutaneous injections of either teriparatide (20 µg/day; 19 patients) or saline (15 patients), with all patients receiving oral calcium carbonate and vitamin D, as well as standard clinical care for MRONJ. All patients were followed for 12 months, and underwent oral examinations performed at 0, 4, 8, 12, 24, 36, and 52 weeks, conical beam computed tomography (CBCT) performed at 0, 4, 8, and 52 weeks, and 18F-fluoride positron emission tomography/computed tomography (PET/CT) imaging performed at 0 and 8 weeks.

Other assessments included quality of life using the Oral Health Impact 14 (OHIP-14) questionnaire, evaluation of bone mineral density at 0 and 52 weeks, and measurements of circulating markers of bone turnover, including procollagen type 1 N-propeptide (P1NP), at each study visit.

The primary study outcome was resolution of MRONJ as measured by oral examination and CBCT imaging.

The median age of the study population was 64 years, and approximately 80% of patients had received antiresorptive therapy for malignant bone disease.

A key study finding was a higher percentage of resolution of MRONJ lesions at 52 weeks in those receiving teriparatide (45.4%) compared with placebo (33.3%), with corresponding odds ratios for MRONJ resolution of 0.15 compared with 0.40 (P =.013).

In addition, a higher proportion of patients receiving teriparatide (80.0%) showed increased bone volume and a

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IN THE NEWS

Read more at https://bit.ly/ONA1020b

MPN Genomic Calculator Performs Well in Real-Life Cohort of Patients With ET The Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs), including essential thrombocythemia (ET), polycythemia vera (PV), and myelofibrosis (MF), are characterized by the clonal proliferation of one or more mature cell types from myeloid lineages, such as erythrocytes, granulocytes, and/or platelets.

The previously developed MPN Genomic Calculator is a freely available online research tool that was designed to incorporate clinical, laboratory, and genomic characteristics to facilitate prediction of clinical outcomes for individual patients with MPNs. In this study, the prognostic accuracy of the MPN Genomic Calculator was evaluated using a real-life group of young (younger than 60 years) patients with ET. Data related to overall survival (OS), event-free survival (EFS), and progression to MF or acute myeloid leukemia (AML), as well as established driver mutations, for these patients had been collected as part of an observational cohort study conducted in Brest, France (ClinicalTrials.gov Identifier: NCT02897297).

Of the 165 patients with ET included in the analysis, 101 (61.2%) were female and median patient age was 49.5 years.

Approximately three-quarters of patients had received treatment with cytoreductive therapy.

A key study finding was a high level of concordance between the 5-year OS rates that were observed (96.4%) and those estimated using the MPN Genomic Calculator (97.3%) for this cohort of patients. Furthermore, the 10-year OS rate (93.9%) observed for this group of patients was also similar to 10-year OS calculated using the online tool (91.9%).

In addition, the calculated probability of progression to MF at 10 years (1.6%) was similar to the observed 10-year rate of progression to MF (1.21%), and the estimated and observed 10-year rates of progression to AML were nearly identical at 1.7% and 1.82%, respectively.

The only investigated clinical outcome showing a significant difference when the observed and calculated values were compared was the median EFS, which was 25.8 years (observed) vs 20 years (calculated; P =.002).

Read more at https://bit.ly/ONA1020d

Reducing Time to Alkalinization Prior to HD-MTX Does Not Reduce Hospital Length of Stay Addition of acetazolamide reduced time to urine alkalinization, allowing for earlier administration of high-dose methotrexate (HD-MTX), according to study findings from a single-center, retrospective review.

This study included 55 adult patients Stays were similar who had received at least 500 mg/m2 with 3 regimens. (mean dose, 5400 mg/m2) HD-MTX (in a total of 196 cycles) between 2016 and 2019 at the Augusta University Medical Center. Patients were pretreated to achieve urine alkalinization (pH ≥7) by intravenous (IV) sodium bicarbonate (NaHCO3) monotherapy (41 cycles), IV-NaHCO3 with acetazolamide (70 cycles), or by oral bicarbonate (PONaHCO3) with acetazolamide (76 cycles).

Treatment groups differed by age (P =.009), race (P =.002), cycle number (P =.037), HD-MTX dose (P =.006), acetazolamide dose (P =.001), and acetazolamide dose duration (P =.001).

Time from first alkalinization dose to start of HD-MTX was longest for the monotherapy cohort (median, 7.5 hours; interquartile range [IQR], 5.6-18.3; P =.003) compared with IV dual therapy (median, 5.8 hours; IQR, 3.6-9.1) or oral dual therapy (median, 5.2 hours; IQR, 3.8-7.9).

Although the treatment groups differed for time to alkalinization, time from alkalinization to hospital release did not differ significantly (P =.054) between monotherapy (median, 123.1 hours; IQR, 97.5-197.9), IV dual therapy (median, 123.7 hours; IQR, 102.4-150.6), and oral dual therapy (median, 125 hours; IQR, 99.4-170.3).

Read more at https://bit.ly/ONA1020g

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reduction in the size of bony defects at 12 months compared with those receiving saline injections (31.3%; OR, 8.1; 95% CI, 1.36-66.20; P =.017).

Furthermore, the level of P1NP was 3 times higher at 4and 8-week assessments for those treated with teriparatide compared with placebo (P =.001), and the former group was more likely to exhibit increased uptake on metabolic imaging compared with the latter.

No significant differences between study groups were observed with respect to bone mineral density at any skeletal site, quality of life, or the frequency of adverse effects, including injection site reactions, gastrointestinal symptoms, and musculoskeletal pain.

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Hearing Loss Associated With Neurocognitive Deficits in Pediatric Cancer Survivors There is a substantial body of literature on the negative impact of hearing impairment occurring prior to the development of language skills on academic performance in children.

However, few studies have assessed these measures in the setting of Platinum drugs acquired hearing impairment despite caused greater loss. known ototoxicity associated with many childhood cancer treatments, such as platinum-based chemotherapy and cranial radiotherapy (CRT).

This study included 1520 childhood cancer survivor participants from the St. Jude Lifetime Cohort Study. All participants included in this analysis had to have survived at least 5 years following their original cancer diagnosis, and had to be eligible for audiologic evaluation, including otoscopy, tympanometry, pure tone audiometry, and speech audiometry evaluations, as well as neurocognitive testing that included assessments of intelligence, attention, memory, executive function, processing speed, and academic function.

An audiogram grade based on the Chang Ototoxicity Grading Scale was used to categorize degree of hearing loss, with a grade of 0 representing normal hearing, grades 1a, 1b, and 2a corresponding to mild hearing impairment, and a grade of 2b or higher representing severe hearing impairment.

The median age of the survivors included in this analysis was 29.4 years, and the median time since diagnosis of the original cancer was 20.4 years.

Of the childhood cancer survivors participating in this study, 37.7% were found to be hearing impaired, with 14.5% classified as having mild hearing impairment and 23.2% as having severe hearing impairment.

Of note, 7.3% and 8.8% of participants without a history of exposure to ototoxic therapy were found to have mild and severe hearing impairment, respectively, leading the study authors to comment that “severe [hearing impairment] in the no exposure group was more prevalent in survivors aged 7 to 39 years compared with the general US population.”

A key study finding was that the relative risk (RR) ratio for development of severe hearing impairment was 1.68 and 2.69 for those exposed to platinum-based chemotherapy and those treated with CRT with or without exposure to platinum-based chemotherapy, respectively, compared with those survivors without exposure to ototoxic therapy.

Interestingly, in the group of cancer survivors without hearing loss who had undergone treatment with platinum-based

chemotherapy, approximately 70% had been treated with carboplatin chemotherapy only.

Regarding neurocognitive impairment, childhood cancer survivors with severe hearing impairment were found to be at significantly higher risk of deficits in verbal fluency, verbal reasoning skills, word reading skills, and mathematical computational skills compared with those survivors with mild or no hearing impairment.

In addition, the risks for deficits in attention, processing speed, and executive function were significantly higher for those with severe hearing loss vs not.

For instance, compared with survivors without severe hearing impairment, the relative risks for impaired focused attention were 2.56 for survivors with severe hearing impairment and exposure to platinum-based chemotherapy and 1.57 for survivors who received CRT with or without platinum-based chemotherapy.

Read more https://bit.ly/ONA1020h

Restructured Process Overcomes Barriers to Prior Authorization for Proton Therapy Redesign of a prior authorization process at a proton therapy center was associated with an expedited appeals process.

Prior authorization is a management process instituted by health insurance companies whereby certain prescribed procedures, services, or medications must be pre-approved by the payor prior to their implementation to ensure coverage.

In 2017, with the goal of expediting the authorization process for proton beam therapy (PBT), a single proton therapy center launched an initiative that involved restructuring its internal team. The changes included replacing the historical administrative staff with clinical medical dosimetrists, who are uniquely trained in radiation oncology.

In this administrative role, the advanced practice dosimetrists independently pursued authorization rebuttals and directly helped relevant stakeholders navigate the multilayered authorization process, thus reducing the burden of administrative tasks on clinical teams, explained the study authors.

In addition, the previous authorization process team manager was replaced by “a medical executive with extensive firsthand experience in the insurance authorization process,” and an automated electronic system was put in place for the purpose of tracking steps in the authorization process.

During an 18-month period between October 2016 and March 2018, 1700 patients were involved in the authorization

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IN THE NEWS

Read more at https://bit.ly/ONA1020f

Rapid Third-Infusion Protocol of Daratumumab in Patients With RRMM For patients receiving daratumumab as treatment of relapsed/ refractory multiple myeloma (RRMM), a new study has revealed a rapid third-infusion protocol to be both safe and well tolerated.

Eligible patients with RRMM in this study received their first 2 intravenous infusions of daratumumab at standard administration rates, as monotherapy or as part of a combination treatment. This observational study was conducted at the University Hospital in Dijon, France, and it examined the effects of giving a third (or later) infusion over 90 minutes instead of the usual 210 minutes.

In this rapid infusion process, the rate of infusion began at 200 mL/hour for 30 minutes. If infusion-related reactions (IRRs) did not occur, then administration was continued at a rate of 400 mL/hour, for a total of 500 mL administered.

Premedication therapies were given as recommended for all patients. The primary study outcome was safety with this approach.

One or more 90-minute infusions of daratumumab were given to 25 patients in this study, for a total of 53 infusions lasting 90 minutes. Comorbidities were reported in 10 patients (40%).

Grade 1 hypertension occurred in 2 patients, and grade 1 hypotension occurred in 2 patients. These alterations of blood pressure were reported to occur in patients who had poorly controlled blood pressure prior to the intervention.

Grade 3 to 4 hypertension or hypotension did not occur.

Fatigue was reported in 5 patients. IRRs were noted for a total of 4 patients, and all of these were at grade 1.

With no evidence of grade 2 or higher IRRs in this study, the researchers considered the rapid infusion protocol to be safe.

Read more at https://bit.ly/ONA1020k

Frailty Linked to Poor Postsurgical Outcomes in Patients With Ovarian Cancer Researchers demonstrated that frailty may be a factor in some outcomes following surgery in patients with ovarian cancer.

Patients evaluated in this study underwent laparotomy for ovarian cancer during the years 2010 through Assessment at index 2014 and were identified through the admission is key.

Nationwide Readmissions Database.

They were considered frail or not frail using the Johns Hopkins Adjusted Clinical Groups Frailty Diagnoses indicators. Outcomes were evaluated for patients at index admission and at 30 and 90 days following surgery.

In this study, a total of 76,441 inpatient laparotomies were found. The frailty rate among the involved patients was 6.1%. Frailty was associated with risks of multiple poorer outcomes during the index admission. These included a higher risk of inpatient mortality (adjusted risk ratio [aRR], 1.91; 95% CI, 1.63-2.23; P <.01). Also, during index admission, frailty was linked to a higher risk of a requirement for intensive care (aRR, 1.76; 95% CI, 1.68-1.85; P <.01) and to a higher risk of nonroutine discharge (aRR, 1.39; 95% CI, 1.33-1.45; P <.01).

In the 90 days following surgery, frailty was associated with readmission (aRR, 1.11; 95% CI, 1.04-1.18; P <.01) and with mortality during a readmission (aRR, 1.31; 95% CI, 1.01-1.69; P =.04). The 30-day aRR for readmission with frailty was 1.09 (95% CI, 1.01-1.17; P =.02), and frailty was not associated with mortality during readmission in the 30-day period (aRR, 1.20; 95% CI, 0.88-1.63; P =.25). ■ Read more at https://bit.ly/ONA1020l

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process for proton therapy at the center. Although 1266 (74%) of these patients ultimately received approval for PBT, 633 were initially denied insurance coverage for the procedure.

Of these, appeals were entered for 454 patients, with 199 of the denials being reversed.

To evaluate the impact of the restructured team on the prior authorization process, comparisons were made of specific metrics associated with 6-month periods corresponding to pre-restructuring (October 2016 to March 2017) and post-restructuring (October 2017 to March 2018) of the authorization team.

A key finding was a significant reduction in the median time of post-appeal approval from 30 days during the prerestructuring period to 18 days during the post-restructuring period (P <.001). In addition, the rates of overturned denials and internal referrals increased by 56% and 29%, respectively, following the restructuring of the authorization team.

Furthermore, a 37% increase in the rate of patients starting PBT for the first time was observed during the post- compared with the pre-restructuring period.

SPECIAL EDITION: ONCOLOGY NAVIGATION

Navigation 101 A review and update on the role of oncology nurse navigators and how they fit into the cancer care team.

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O

ncology nurse navigation is a supportive service offered to cancer patients and their families. There are specific skills and knowledge new navigators and program leaders need to be aware of to develop, grow, and sustain a navigation program. After conducting a role delineation study, the Oncology Nursing Society (ONS) developed the Oncology Nurse Navigator Competencies in 2013. The core competencies were updated in 2017 to include both novice and expert categories of knowledge, skills, and tasks needed to successfully fill the role of the oncology nurse navigator (ONN). The competencies are divided into 4 main categories: coordination of care, communication, education, and professional role.

Coordinated care provides timely access to oncology care by addressing patient barriers and providing interventions.

ONNs develop a keen awareness of the types of physical, emotional, and psychosocial barriers that patients may face (ie, financial concerns, lack of caregiver support, transportation needs) and work within their healthcare system as well as with local and national organizations to overcome such barriers. Effective communication skills aid ONNs in their ability to educate patients and families regarding the disease process and next steps. ONNs skilled in communication techniques can educate patients and families by translating medical knowledge into content patients can use to improve their understanding of their disease, manage side effects, and empower them to advocate for what they need throughout their cancer journey. Finally, professional role development can assist the ONN in moving through the stages from novice to expert.

In addition to identifying the entry points into navigation (ie, at diagnosis, tumor boards, referral to oncology), determining key touch points where the ONN proactively reaches out to the patient is paramount.Touch points help structure and define the ONN role. It is important for the roles of other clinical staff such as clinic nurses, medical assistants, and advanced practice providers (APPs) to be clearly defined, thereby reducing duplicate work being done on behalf of the patient.

ONS updated its competencies for navigators to include both novice and expert levels of knowledge, skills, and tasks.

The knowledge, skills, and tasks common to ONNs can enhance any of the various models of navigation. Institutions choose models that can best fit the needs of their patient population and available resources. Examples of navigation models include the professional model where the navigator is a bachelor- or masters-prepared nurse or social worker and focus is on addressing clinical barriers.The nonlicensed model employs the services of community health workers and/or lay advisors who are trained to provide culturally tailored navigation for people within their community and to overcome nonclinical barriers to care. Other navigation models integrate services across service lines, settings, and may utilize risk/acuity tools.

Navigation programs and ONNs themselves must measure their successes through the use of defined metrics specific to navigation. The Academy of Oncology Nurse and Patient Navigators (AONN) has defined 35 metrics. Additionally, patient reported outcomes (PROs), clinical pathway adherence, and measuring the return on investment generated through a navigation program are key indicators of the successes and gaps in navigation. Things to consider when selecting which metrics to measure include time and ease of data collection, program size and scope, and input from organizational leaders and stakeholders. Data can be collected manually, or captured within the electronic medical record or with a stand-alone or integrated software platform.

Overall, a successful ONN will build upon these principles of navigation while adding their unique talents to the role. ■ —Deborah Christensen, MSN, APRN, AOCN, OCN; Judy Koutlas, RN, MS, OCN

www.OncologyNurseAdvisor.com • SEPTEMBER/OCTOBER 2020 • ONCOLOGY NURSE ADVISOR 19

SPECIAL EDITION: ONCOLOGY NAVIGATION

A cancer rights attorney explains the basics of health insurance options available to patients with cancer who do not have employer-sponsored health insurance.

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fter receiving a cancer diagnosis, many patients may struggle to understand even the most rudimentary parts of their life. Furthermore, even without a cancer diagnosis, many people do not understand the terms used in their health insurance policy, such as the acronyms HMO, PPO, and HSA. In an oral presentation at the 2020 Oncology Nurse Advisor Virtual Navigation Summit, Joanna Fawzy Morales, Esq, a cancer rights attorney and CEO of Triage Cancer, a national, nonprofit organization connecting people to cancer survivorship education, discussed the challenges related to health insurance that patients with cancer may face and what their navigators should know.

Most people are required to have health insurance, which can be an employer-sponsored or individual plan; Medicare, Medicaid, or Veterans Health; COBRA/HIPAA; or a high-risk pool. Federal income tax fines for not having an approved health insurance plan dropped to 0% in 2019.

However, people in California, Massachusetts, New Jersey, Rhode Island, Vermont, and Washington, DC, incur a state tax penalty for not having health insurance.

Researchers from Duke University investigated the impact of out-of-pocket expenses in 2013, and coined the term “financial toxicity” to describe how out-of-pocket medical expenses can have the same effect on quality of life as treatment-related physical toxicity. Factors that contribute to the financial concerns of patients with cancer include employment changes and life changes, both of which can affect the most significant contributor: health insurance status.

Strategies to avoid financial toxicity involve considering the complete cost of health insurance, including

out-of-pocket maximums, deductibles, and cost-share amounts. Additionally, whether prescription drugs and outof-network vs in-network providers incur separate deductibles and out-of-pocket maximums needs to be considered.

Practical concerns, such as travel expenses, durable medical equipment, comfort and cosmetic needs, and complementary therapies, and personal issues, such as caregiver needs of minor children and/or aging parents and help with meals/ household, also add to the cost of health care.

Although the federal mandate to carry health insurance has been lifted, some basic protections are still in effect for patients that may be used to manage financial toxicity associated with oncology care. Insurance companies cannot cancel a policy when a person has cancer; nor can they impose lifetime or annual limits on coverage. Young adults can stay on their parent’s plan until age 26. Preventive care such as immunizations and cancer screening must be fully covered, as well as those services rated A/B by the US Preventive Services Task Force. This also includes mammography for women aged 40 and older, coverage of routine costs while participating in clinical trials, and access to internal and external appeals of coverage denials.

MEDICARE As it relates to Medicare, consumers must choose 1 of 2 plans: original Medicare or Medicare Advantage (Part C). Both plans include hospital insurance (Part A) and

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Navigating Health Insurance for Patients With Cancer

SPECIAL EDITION: ONCOLOGY NAVIGATION

Preventive care such as immunizations and cancer screening must be covered, as well as those services rated A/B by the US Preventive Services Task Force.

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SPECIAL EDITION: ONCOLOGY NAVIGATION

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coverage are accepted year round. Plans are administered by the states, therefore navigators should be aware of their state’s Medicaid eligibility criteria and enrollment and renewal processes.

Consumers must choose 1 of 2 plans: original Medicare or Advantage (Part C). Both include hospital (Part A) and medical (Part B) insurance. medical insurance (Part B), as well as optional prescription drug coverage (Part D). With the original plan, patients can also obtain supplemental insurance (a Medigap plan).

Consumers can enroll or change their plans during open enrollment, which is from October 15 to December 7 of each year. Plans are for the calendar year.

MEDICAID For Medicaid, eligibility criteria include low income (less than 138% of federal poverty level [FPL]) plus low resources plus one of the following: aged, blind, disabled; persons undergoing breast and cervical cancer treatment; minor persons or adults with minor children (Medicaid programs for children are administered as the Children’s Health Insurance Program [CHIP]2); and pregnant women, for up to 6 months after the baby’s birth.

Most states have opted for Medicaid expansion, which adds a separate category for adults with a household income less than 138% of FPL. This category is income-based only (range, $17,609 for a 1-person household to $48,521 for a 6-person household), with no asset/resource test. As of July 6, 2020, voters in Missouri and Oklahoma approved a ballot measure to expand Medicaid coverage effective July 1, 2021, and the following 12 states have not expanded their coverage: Alabama, Florida, Georgia, Kansas, Mississippi, North Carolina, South Carolina, South Dakota, Tennessee, Texas, Wisconsin, and Wyoming. Applications for Medicaid

COBRA COBRA allows patients to keep their employer-sponsored coverage for up 18 months if their employment ends or their hours are reduced, making them ineligible for the employer’s plan. A patient who reaches age 26 (loss of dependent child status) may qualify for COBRA for up to 36 months. Patients who are covered under another person’s employer-sponsored insurance plan are eligible for up to 36 months of COBRA coverage if the employee enrolls in Medicare, the patient is granted a divorce or legal separation from the employee, or the employee dies. Premium costs are up to 102% of the applicable employee rate.

However, not all employers are eligible to participate in COBRA. Employers with fewer than 20 employees are exempt from federal COBRA laws, but some states may have mini-COBRA laws. In addition, federal employees and church and church-related organization employees are not covered by COBRA. Federal employees may be eligible for Temporary Continuation of Coverage (TCC).

STATE-SPECIFIC OPTIONS All 50 states and Washington, DC, offer either a state or federal health insurance marketplace, or “exchanges.”

Patients and navigators should check to see what their state’s program offers, which can include a cap on out-of-pocket costs, premium tax credits, or cost-sharing subsidies. Open enrollment for 2021 marketplace insurance is November 1 through December 15, 2020; however, it may be longer in some states, and marketplaces are open now in California and Washington, DC. A chart of state-by-state health insurance options is available at https://triagecancer.org/ health-insurance-state-laws#hioptions. ■

—Joyce Pagán

REFERENCES 1. Fawzy Morales J. Navigating health insurance. Oral presentation at: 2020 ONA Virtual Navigation Summit; September 12-13, 2020.

2. Medicaid.gov. Children’s Health Insurance Program (CHIP): Eligibility standards. Accessed September 11, 2020. https://www.medicaid.gov/ chip/eligibility/index.html

www.OncologyNurseAdvisor.com • SEPTEMBER/OCTOBER 2020 • ONCOLOGY NURSE ADVISOR 21

SPECIAL EDITION: ONCOLOGY NAVIGATION

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Navigation Strategies for Chimeric Antigen Receptor T-Cell (CAR-T) Therapy and Hematologic Cancers

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atients undergoing chimeric antigen receptor T-cell (CAR-T) therapy will experience challenges and potential barriers unique to this treatment. In this presentation, we offer solutions to help navigate patients through and around these barriers, and discuss posttreatment and long-term survivorship care.

T lymphocytes (T-cells) are the “soldiers” of the immune system. They can kill abnormal cells by recognizing peptides presented in HLA molecules. Adoptive T-cell therapies involve engineering T-cells to recognize and attack tumor cells. CAR-T cells are engineered to express a synthetic T-cell receptor for a tumor.

CAR-T therapy is a 4-step process. First, T-cells are harvested from the patient’s blood. In the laboratory, the T-cells are engineered to become CAR T-cells, then allowed to multiply until there are millions of them. The last step is to return the now-engineered T-cells to the patient’s bloodstream where they recognize and kill cancer cells.

Currently, 4 agents have been granted FDA approval: Tisagenlecleucel (Kymriah®) is approved for the treatment of patients younger than 26 years with relapsed/ refractory (r/r) acute lymphocytic leukemia and for the treatment of adults with r/r large B-cell lymphoma after 2 or more lines of systemic therapy. Axicabtagene ciloleucel (Yescarta®) is approved for the treatment of adults with r/r large B-cell lymphoma after 2 or more lines of systemic therapy; and brexucabtagene autoleucel (Tecartus™) was recently approved for the treatment of adults with r/r mantle cell lymphoma.

Other CAR-T therapies currently in development are lisocabtagene maraleucel, a CD19 CAR-T, and idecabtagene vicleucel, orvacabtagene autoleucel, and JNJ-4528, which are BCMA CAR-T therapies.

Common toxicities of therapy are tumor lysis syndrome, B cell aplasia, hemophagocytic lymphohistiocytosis (HLH)-like syndrome, disseminated intravascular coagulation (DIC), cytopenias, and infection. However, the 2 major treatmentrelated complications are cytokine release syndrome (CRS)

and neurotoxicity, which is now formally called immune effector cell-associated neurotoxicity syndrome (ICANS).

Overall, the general complications of CRS and ICANS appear to be similar across the FDA-approved agents, but their frequency, rate of onset, and general peak level of toxicity varies. Regarding efficacy, the response rates for each of the 3 approved therapies are comparable.

The barriers unique to CAR-T therapy are geographical factors (must be within 30-120 minutes travel time of the treatment facility), length of treatment (approximately 2 months), financial burden (travel and lodging costs, as well as medical expenses), caregiver requirements, and high-risk population. Some strategies navigators can use to help patients navigate through this often difficult process include early initiation of financial clearance, clear and thorough communication with the patient and their caregivers, coordination with internal patient resources, awareness of available community resources, and access to patient-learning resources.

Patients and their caregivers must remain close to the treatment facility for 1 month after CAR T-cell infusion.

After that time, the patient is transitioned back to their oncologist for continued follow-up care. The FDA recommends following patients for 15 years posttreatment.

The components of follow-up care include an annual physical examination; monitoring for replication-competent retroviruses (RCRs) and persistence every 6 months for years 1 to 5, then annually for years 5 to 15; monitoring for adverse events of special interest (AESI) related to gene therapy; revaccination; and quality of life questionnaires. ■ —Erin Mullane, FNP-C, DNP, BSN; Katie M. Gieseke, ARNP, FNP-BC, DNP

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Navigation Strategies for Patients With Breast Cancer

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reast cancer is the most common cancer in women except for skin cancer. One in 8 women will develop breast cancer in their lifetime. Breast cancer will be diagnosed in an estimated 276,480 women in the United States in 2020, and 42,170 will succumb to their disease.

The rate of breast cancer deaths has decreased by 40% since the 1980s due to early detection and improvements in treatment. However, disparities in care exist, resulting in poor outcomes. The disease is less likely to be diagnosed in African American, Hispanic, American Indian, and Alaskan women at an early stage. African American women are more likely to develop breast cancer at a younger age, have a higher risk of developing triple-negative breast cancer, and are more likely to succumb to their disease.

The role of breast cancer navigation is to overcome barriers to care throughout the care continuum. Breast cancer navigation promotes access to care, timely treatment, and adherence to therapy resulting in better outcomes. Breast cancer navigators must possess the knowledge and skills required to earn a trusting relationship and rapport with their patients. Navigators should assess each patient to identify their potential barriers to care. Some common

Common barriers to care are financial issues, transportation, fear, depression, addiction, mental health disorders, and poor social support.

barriers to care are financial issues, transportation, fear, depression, addiction, mental health disorders, and poor social support. Lack of medical literacy and knowledge of their disease and treatment are additional barriers.

Breast cancer screening is important to identify breast cancers at an early stage. However, there is a lack of consensus in the recommended screening guidelines between the United States Preventive Services Task Force (USPSTF), the American Cancer Society, and a consortium of physician groups such as the American College of Radiology, the American College of Obstetricians and Gynecologists, and the American Academy of Physicians. Primary care provider recommendation is a strong predictor of whether breast cancer screening occurs.

A mechanism to remind patients about their breast cancer screening should be in place, and underserved women proactively linked to the National Breast and Cervical Cancer Early Detection Program or alternate free screening program. Navigator involvement in the screening process and follow-up of suspicious findings is important to ensure timely access to appropriate care.

Patient understanding of medical information is a prerequisite to treatment adherence. Assessment of patient understanding of the diagnosis and treatment recommendations is critical. Navigators can simplify complex information for the patient and promote increased understanding, enabling a more informed treatment decision.

The work of nonclinical navigators improves the overall quality of care simultaneously decreasing healthcare delivery costs. Nonclinical navigators are an important link, providing focus to a variety of patient social services: social workers, financial counselors, food banks, transportation services, support groups, and wellness programs. Nonclinical navigators provide invaluable 1-on-1 emotional support that helps patients cope with their disease.

At Vidant Cancer Center, we learned through experience that nonclinical breast navigators enabled our breast nurse navigator to focus on clinical barriers, while they addressed nonclinical barriers. By implementing nonclinical breast navigator services into our breast cancer program, we were able to increase the number of new patient encounters by 29% and return patient encounters by 27%.

Ensuring the successful outcome of breast cancer survivorship requires patient access to early breast cancer screening and patient support from a breast cancer navigator. ■ —Debra Mascarenhas, RN, BSN, CBCN

www.OncologyNurseAdvisor.com • SEPTEMBER/OCTOBER 2020 • ONCOLOGY NURSE ADVISOR 23

NAVIGATION NOTES Influence of Social Determinants of Health on Health Equity Janice Phillips, PhD, RN, CENP, FAAN

result, health care systems, insurers, and others are looking to address the social determinants of health as a means to improve health outcomes and decrease health care costs.

Patient navigators are key to any efforts devoted toward reducing health disparities and ultimately achieving health equity. By nature of their close proximity to patients and families, patient navigators are encouraged to assess for the influence of the determinants of health on cancer outcomes.

Navigators are well positioned to provide excellent navigation services that address the determinants of health and advocate for programs and policies that can mitigate the unfavorable influence of the social determinants of health on cancer care and cancer outcomes. ■ REFERENCES 1. World Health Organization. Social Determinants of Health. Accessed September 12, 2020. https://www.who. int/gender-equity-rights/understanding/ sdh-definition/en/ 2. University of Wisconsin Population Health Institute. County health rankings model.

Accessed September 12, 2020. https:// www.countyhealthrankings.org/explorehealth-rankings/measures-data-sources/ county-health-rankings-model 3. Alcaraz KI, Wiedt TL, Daniels EC, Yabroff KR, Guerra CE, Wender RC. Understanding and addressing the social determinants of health to advance cancer health equity

Although health care expenditures continue to rise in the United States, the United States experiences some of the poorest health outcomes compared with other developed countries.4 As a

in the United States: a blueprint for practice, research, and policy. CA Cancer J Clin.

2020;70(1):31-46. doi:10.3322/caac.21586 4. Shi L, Singh D. Essentials of the Health Care System. Jones and Bartlett Learning; 2018.

These social, economic, and physical environmental factors may contribute as much as 80% to health outcomes.

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ocial determinants of health (SDoH) have emerged as some of the most important factors influencing the health outcomes of people and communities worldwide.

The World Health Organization provided one of the earlier definitions of the social determinants of health: “The conditions in which people are born, grow, live, work and age. The distribution of money, power and resources at global, national and local levels shapes these circumstances.”1 Addressing the social determinants is an integral component of our efforts to achieve health equity. To ensure that everyone has a fair and just opportunity to be healthy, we must remove those underlying factors known to affect the health and well-being of people and communities at large.

Experts identify factors such as economic stability (employment, income, expenses, debt), neighborhood/physical environment (housing, transportation, walkability, zip code), education (literacy, language, level of education, vocational training), food (hunger, access to nutritious foods), community and social context (social integration, support network, discrimination, stress), and health care (health coverage, provider availability, linguistic and cultural competency) as some of the most influential drivers shaping health outcomes (such as life expectancy, health outcomes).

These social, economic, and physical environmental factors may contribute as much as 80% to health outcomes.

Traditional clinical care contributes the remaining 20%.2,3

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