NCI Community Oncology Research Program Research Articles

Improving the Process of Screening for Medical Financial Hardship in Oncology Practice.

Medical financial hardship, including problems paying medical bills, distress, and forgoing care because of cost, is increasingly common among patients receiving cancer treatment and cancer survivors across the economic spectrum. Little is known, however, about provider practices for identifying patients who experience financial hardship and the strategies for mitigating hardship and addressing patient needs. In this editorial, we discuss a study of practices within the NCI Community Oncology Research Program. McLouth and colleagues found disparities in the use of screening and financial navigation and reliance on inadequate screening methods. To address these disparities, we emphasize the importance of comprehensive and ongoing financial hardship screening throughout the course of cancer treatment and survivorship care, as well as the necessity of accompanying counseling, navigation, and referrals. We also recommend key attributes of screening tools and a process for systematic implementation within clinical practice. With adverse health and economic consequences of the COVID-19 pandemic disproportionately affecting people who are racial or ethnic minorities, uninsured or underinsured, or living in poverty, the need to address medical financial hardship is more urgent than ever, to ensure that all people have an equal opportunity for high quality cancer treatment and survival.See related article by McLouth et al., p. 669.

Barriers and Facilitators to Adolescent and Young Adult Cancer Trial Enrollment: NCORP Site Perspectives.

BackgroundAlthough it is well documented that adolescents and young adults (AYAs) with cancer have low participation in cancer clinical trials (CCTs), the underlying reasons are not well understood. We used the National Cancer Institute Community Oncology Research Program (NCORP) network to identify barriers and facilitators to AYA CCT enrollment, and strategies to improve enrollment at community-based and minority and/or underserved sites.MethodsWe performed one-on-one semistructured qualitative interviews with stakeholders (NCORP site principle investigators, NCORP administrators, physicians involved in enrollment, lead clinical research associates or clinical research nurses, nurse navigators, regulatory research associates, patient advocates) in the AYA CCT enrollment process. NCORP sites that included high and low AYA–enrolling affiliate sites and were diverse in geography and department representation (eg, pediatrics, medical oncology) were invited to participate. All interviews were recorded and transcribed. Themes related to barriers and facilitators and strategies to improve enrollment were identified.ResultsWe conducted 43 interviews across 10 NCORP sites. Eleven barriers and 13 facilitators to AYA enrollment were identified. Main barriers included perceived limited trial availability and eligibility, physician gatekeeping, lack of provider and research staff time, and financial constraints. Main facilitators and strategies to improve AYA enrollment included having a patient screening process, physician endorsement of trials, an “AYA champion” on site, and strong communication between medical and pediatric oncology.ConclusionsStakeholders identified several opportunities to address barriers contributing to low AYA CCT enrollment at community-based and minority and/or underserved sites. Results of this study will inform development and implementation of targeted interventions to increase AYA CCT enrollment.

A cluster randomized controlled trial comparing Virtual Learning Collaborative and Technical Assistance strategies to implement an early palliative care program for patients with advanced cancer and their caregivers: a study protocol

BackgroundVirtual Learning Collaboratives (VLC), learning communities focused on a common purpose, are used frequently in healthcare settings to implement best practices. Yet, there is limited research testing the effectiveness of this approach compared to other implementation strategies. This study evaluates the effectiveness of a VLC compared to Technical Assistance (TA) among community oncology practices implementing ENABLE (Educate, Nurture, Advise, Before Life Ends), an evidence-based, early palliative care telehealth, psycho-educational intervention for patients with newly diagnosed advanced cancer and their caregivers.MethodsUsing Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Proctor’s Implementation Outcomes Frameworks, this two-arm hybrid type-III cluster-randomized controlled trial (RCT) will compare two implementation strategies, VLC versus TA, among the 48 National Cancer Institute Community Oncology Research Program (NCORP) practice clusters that have not historically provided palliative care to all patients with advanced cancer. Three cohorts of practice clusters will be randomized to the study arms. Each practice cluster will recruit 15–27 patients and a family caregiver to participate in ENABLE. The primary study outcome is ENABLE uptake (patient level), i.e., the proportion of eligible patients who complete the ENABLE program (receive a palliative care assessment and complete the six ENABLE sessions over 12 weeks). The secondary outcome is overall program implementation (practice cluster level), as measured by the General Organizational Index at baseline, 6, and 12 months. Exploratory aims assess patient and caregiver mood and quality of life outcomes at baseline, 12, and 24 weeks. Practice cluster randomization will seek to keep the proportion of rural practices, practice sizes, and minority patients seen within each practice balanced across the two study arms.DiscussionThis study will advance the field of implementation science by evaluating VLC effectiveness, a commonly used but understudied, implementation strategy. The study will advance the field of palliative care by building the capacity and infrastructure to implement an early palliative care program in community oncology practices.Trial registrationClinicaltrials.gov. NCT04062552; Pre-results. Registered: August 20, 2019. https://clinicaltrials.gov/ct2/show/NCT04062552?term=NCT04062552&draw=2&rank=1

DeImplementing Ineffective and Low-Value Clinical Practices: Research and Practice Opportunities in Community Oncology Settings.

Patients, practitioners, and policy makers are increasingly concerned about the delivery of ineffective or low-value clinical practices in cancer care settings. Research is needed on how to effectively deimplement these types of practices from cancer care. In this commentary, we spotlight the National Cancer Institute Community Oncology Research Program (NCORP), a national network of community oncology practices, and elaborate on how it is an ideal infrastructure for conducting rigorous, real-world research on deimplementation. We describe key multilevel issues that affect deimplementation and also serve as a guidepost for developing strategies to drive deimplementation. We describe optimal study designs for testing deimplementation strategies and elaborate on how and why the NCORP network is uniquely positioned to conduct rigorous and impactful deimplementation trials. The number and diversity of affiliated community oncology care sites, coupled with the overall objective of improving cancer care delivery, make the NCORP an opportune infrastructure for advancing deimplementation research while simultaneously improving the care of millions of cancer patients nationwide.

Current Practices for Screening and Addressing Financial Hardship within the NCI Community Oncology Research Program.

Cancer-related financial hardship is associated with poor care outcomes and reduced quality of life for patients and families. Scalable intervention development to address financial hardship requires knowledge of current screening practices and services within community cancer care. The NCI Community Oncology Research Program (NCORP) 2017 Landscape Assessment survey assessed financial screening and financial navigation practices within U.S. community oncology practices. Logistic models evaluated associations between financial hardship screening and availability of a cancer-specific financial navigator and practice group characteristics (e.g., safety-net designation, critical access hospital, proportion of racial and ethnic minority patients served). Of 221 participating NCORP practice groups, 72% reported a financial screening process and 50% had a cancer-specific financial navigator. Practice groups with more than 10% of new patients with cancer enrolled in Medicaid (adjOR = 2.81, P = 0.02) and with less than 30% racial/ethnic minority cancer patient composition (adjOR = 3.91, P < 0.01) were more likely to screen for financial concerns. Practice groups with less than 30% racial/ethnic minority cancer patient composition (adjOR = 2.37, P < 0.01) were more likely to have a dedicated financial navigator or counselor for patients with cancer. Most NCORP practice groups screen for financial concerns and half have a cancer-specific financial navigator. Practices serving more racial or ethnic minority patients are less likely to screen and have a designated financial navigator. The effectiveness of financial screening and navigation for mitigating financial hardship could be tested within NCORP, along with specific interventions to address cancer care inequities.See related commentary by Yabroff et al., p. 593.

Abstract PO-072: Exploring Pacific Islander participation in clinical cancer trials in Guam

Abstract Background. In January 2019, the National Cancer Institute (NCI) approved the addition of FHP Health Center in Guam to its NCI Community Oncology Research Program, making it possible for residents in Guam to participate in NCI-sponsored cancer clinical trials for the first time in Guam's history. Pacific Islanders have historically been significantly underrepresented in NCI-sponsored cancer clinical trials in the nation (Chen et al., 2014). In anticipation of trial recruitment, this pre- pilot study sought to inductively explore community knowledge, beliefs, concerns, and facilitating factors regarding participation in cancer clinical trials in Guam. Methods: Key informants (N=6) were recruited via purposive sampling to represent clerical, government, cultural, and private healthcare sectors. Semi-structured interviews 60 to 90 minutes in length were conducted and transcribed. Qualitative data analysis involved comparisons across the six cases for themes on knowledge, beliefs, concerns, and facilitating factors. Three phases of coding were utilized: initial line-by-line coding per case, general thematic comparisons across cases, and focused analysis on final themes and sub-themes. Results: All participants agreed that advancing cancer research and developing protocols is vital. Cultural and personal beliefs centered on an intergenerational consciousness of cancer and survivability. Dominant concerns were related to distrust and being taken advantage of, as well as fears about harms, risk, and pain. Facilitating factors included the importance of giving hope and that “every option is better than no option.” Participants also expressed that trials would help address the needs of the community given the prevalence of cancer across family generations. Primary recommendations to clinicians and administrators included attention to the safety and “utmost care” of subjects, and transparency regarding risks and benefits of each trial. Conclusions: These initial research findings provide insight into contextual factors that influence Pacific Islander participation, and will be utilized to help develop a larger, population- based pilot study to further explore community concerns, readiness, and recruitment in clinical cancer trials in Guam. Citation Format: Tressa P. Diaz, Corinth Aguon, Ana Joy Mendez. Exploring Pacific Islander participation in clinical cancer trials in Guam [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-072.

Abstract PO-009: Rural/urban and race differences in factors related to cessation readiness among cigarette smokers presenting for lung cancer screening in community settings

Abstract Purpose: Many patients presenting for lung cancer screening are current smokers; screening may be a teachable moment for cessation. The objective of the current analysis is to compare cessation readiness among lung screening patients by rural/urban residence and race/ethnicity to identify populations who may benefit from tailored support. Methods: We enrolled 1,095 current smokers presenting for low dose CT lung cancer screening at 24 NCI Community Oncology Research Program (NCORP) imaging clinics as part of the OaSiS trial (WF 20817CD). Prior to screening, we collected data regarding perceived risk and worry about lung cancer, perceived impact of cessation on lung cancer risk, cessation readiness, and quitting self-efficacy (both 1-10 Likert type scales). We classified participants as rural vs urban using the zip-code-based definitions of the Federal Office of Rural Health Policy. We summarized group differences using chi-square analyses. Results: Participants were 50.2% female; average age 64 years (range 55-79); 81.9% non-Hispanic White (NHW), 13.3% non-Hispanic Black (NHB), 2.6% Hispanic, 2.2% American Indian; 20.2% rural residence). The median cigarettes smoked per day was 20 and the median pack years smoked was 44. NHW participants were less likely than other groups to report being “extremely” worried about lung cancer [15.5% vs NHB (31.4%), Hispanic (35.7%), and American Indian (25%), p&amp;lt;.0001]. When queried about their perceived risk of developing lung cancer, NHB (21.8%), Hispanic (14.3%), and American Indian (12.5%) participants were also more likely to report that they didn’t know, compared to NHW participants (9.7%, p &amp;lt;.0001). NHB participants were more likely to believe that quitting smoking would “very much” reduce their risk of lung cancer (52.1%), compared to NHW (36.3%), Hispanic (35.7%), and American Indian (37.5%) participants (p&amp;lt;.001). NHWs reported lower cessation readiness compared to NHB, Hispanic, and American Indian participants (p&amp;lt;.001). NHB and Hispanic participants also reported high quitting self-efficacy compared to NHW and American Indian participants (p&amp;lt;.0001). With regard to rural/urban differences, compared to urban residents, rural residents reported lower or unknown perceived impact of cessation on lung cancer risk (9.5 vs 6.8% no impact &amp; 13.2 vs 6.9% unknown, p&amp;lt;.01). There were no other differences in cessation readiness factors by rural-urban residence. Conclusions: To advance health equity, it is important to understand cessation readiness, among patients presenting to community-based imaging clinics for lung cancer screening. Evidence-based cessation treatment for racial/ethnic minorities within these settings may be enhanced by tailoring for higher cessation readiness. Rural and racial/ethnic minority patients may benefit from enhanced education regarding lung cancer risk and the impact of cessation. This work was supported by the National Cancer Institute (R01CA207158 &amp; UG1CA189824). Citation Format: Kathryn E. Weaver, Erin L. Sutfin, Emily Dressler, Christina Bellinger, David P. Miller, Caroline Chiles, W. J. Petty, Glenn Lesser, Kristie L. Foley. Rural/urban and race differences in factors related to cessation readiness among cigarette smokers presenting for lung cancer screening in community settings [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-009.

Abstract PO-036: University of Guam/University of Hawai‘i Cancer Center Partnership: A seventeen-year investment in cancer health equity in Pacific Islanders

Abstract The University of Guam (UOG)/University of Hawai‘i Cancer Center (UHCC) Partnership aims to grow cancer research capacity at UOG, develop cancer health disparities research at UHCC focusing on Pacific Islanders (PI), raise awareness of cancer and cancer prevention in Guam (GU), Hawai‘i (HI) and the United States Associated Pacific Islands (USAPI), and increase the number of cancer and biomedical science researchers of PI ancestry in the US. An infrastructure comprised of 4 principal investigators, over 30 participating faculty, administrative staff, and external and internal reviewers, backed by institutional support and NCI sponsorship, has supported 17 years of research, training, and outreach designed to reduce cancer health disparities and advance health equity among PI in GU, HI, and the USAPI. Since 2009, the Partnership has funded 22 cancer research projects addressing cancer research priorities of global and regional relevance, including cervical cancer and Areca (betel) nut chewing - a traditional practice associated with oral pre/carcinoma, affecting 600 million users worldwide. Over 100 peer-reviewed manuscripts have been published, over 100 abstracts presented, and 21 grants secured. To address the underrepresentation of PI in biomedical sciences, the Partnership has supported and trained 35 graduate scholars; 23 master’s students at UOG and 12 doctoral students at UH. Two PhD graduates are now faculty members at UOG and engaged in cancer health disparities research. UOG’s Micronesian Studies Program offers a cancer health disparities track, developed by the Partnership and tailored for the Pacific region. In addition, UOG/UHCC faculty, junior investigators, and pre/postdocs receive mentorship, career development, and summer research fellowships; since 2015, 16 early career professionals have received support. Outreach projects have explored community-based participatory approaches to cancer prevention. Youth tobacco use prevention and cessation projects in Guam resulted in landmark tobacco control legislation, decreased tobacco use and increased tobacco taxes, which now sustain cancer programs and patient services in Guam including the Guam Cancer Registry. Current outreach efforts aim to increase colorectal cancer screening and HPV vaccination while building knowledge and awareness among physicians serving PI in GU and HI. Dedicated leadership and longstanding partner collaborations led to the first NCI Community Oncology Research Program site in 2019, providing therapeutic cancer clinical trials in Guam. In conclusion, research capacity at UOG has significantly increased, disparities research at UHCC has expanded, underrepresented PI students are pursuing careers in cancer research, and communities have been engaged in research, training and outreach to advance cancer health equity in HI, GU and the USAPI. Supported by NCI grants U54CA143727 and U54CA143728. Citation Format: Rachael T. Leon Guerrero, Margaret Hattori-Uchima, Hali R. Robinett, Carl-Wilhelm Vogel, Neal A. Palafox. University of Guam/University of Hawai‘i Cancer Center Partnership: A seventeen-year investment in cancer health equity in Pacific Islanders [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-036.

Caregiver engagement practices in National Cancer Institute Clinical Oncology Research Program settings: Implications for research to advance the field.

Supportive care interventions have demonstrated benefits for both informal and/or family cancer caregivers and their patients, but uptake generally is poor. To the authors' knowledge, little is known regarding the availability of supportive care services in community oncology practices, as well as engagement practices to connect caregivers with these services. Questions from the National Cancer Institute Community Oncology Research Program (NCORP)'s 2017 Landscape Survey examined caregiver engagement practices (ie, caregiver identification, needs assessment, and supportive care service availability). Logistic regression was used to assess the relationship between the caregiver engagement outcomes and practice group characteristics. A total of 204 practice groups responded to each of the primary outcome questions. Only 40.2% of practice groups endorsed having a process with which to systematically identify and document caregivers, although approximately 76% were routinely using assessment tools to identify caregiver needs and approximately 63.7% had supportive care services available to caregivers. Caregiver identification was more common in sites affiliated with a critical access hospital (odds ratio [OR], 2.44; P = .013), and assessments were less common in safety-net practices (OR, 0.41; P = .013). Supportive care services were more commonly available in the Western region of the United States, in practices with inpatient services (OR, 2.96; P = .012), and in practices affiliated with a critical access hospital (OR, 3.31; P = .010). Although many practice groups provide supportive care services, fewer than one-half systematically identify and document informal cancer caregivers. Expanding fundamental engagement practices such as caregiver identification, assessment, and service provision will be critical to support recent calls to improve caregivers' well-being and skills to perform caregiving tasks.

Cumulative incidence of financial hardship in metastatic colorectal cancer (mCRC) patients (pts): Primary endpoint results for SWOG S1417CD.

137 Background: Despite evidence that rising cancer care costs contribute to “financial toxicity” in cancer pts, no studies, to our knowledge, have prospectively assessed the financial impact of cancer diagnosis (dx) using both self-reported and objective financial measures. S1417CD, led by the SWOG Cancer Research Network and conducted in the NCI Community Oncology Research Program (NCORP), was the first national prospective cohort study to evaluate time-to-first evidence of major financial hardship (MFH) in pts with newly diagnosed mCRC. We present results of the primary endpoint analysis. Methods: Pts age ≥ 18 within 120 days of mCRC dx receiving systemic treatment completed surveys every 3 months (mo) for 12 mo. MFH was defined as ≥ 1 occurrence of self-reported increase in debt, new loans, selling home, refinancing home, or ≥ 20% income decline during the 12 mo study period. Cumulative incidence (CI) of MFH was estimated to account for competing risk of death. Multivariate logistic regression was used to evaluate the association between pt characteristics with development of MFH. Results: 380 pts (median age 59.9) across 126 clinic sites were enrolled. Most pts were white (78%), male (61%), and insured (98%), with annual income ≤ $50,000 (56%). Cumulative incidence of MFH at 12 mo was 71.5% (95% CI: 65.9%-76.3%), with 24.6%, 52.4%, and 61.8% at 3, 6, and 9 mo; 104 (41%) pts reported ≥ 2 elements of MFH. Age, race, marital status, employment, and annual income (≤ vs. &gt; $50K) were not significantly associated with MFH. In a post hoc analysis, income &lt;$100,000 and total assets &lt;$100,000 were both adversely associated with MFH. Each increase in number of these 2 risk factors from 0 to 1 and 1 to 2 was associated with a 49% increased risk of MFH (p&lt;.001). Conclusions: In a national sample of mCRC pts on systemic tx, financial hardship, most commonly in the form of increased debt, accumulates progressively over time. Nearly 3 out of 4 pts experiencing MFH at 12 mo despite access to health insurance coverage. These findings underscore the need for clinic and policy solutions such as early financial navigation and elimination of cost sharing to protect pts from financial devastation as they continue with tx. [Table: see text]

A geriatric assessment (GA) intervention for older patients with advanced cancer: Secondary outcomes from a University of Rochester cancer center NCI community oncology research program cluster randomized controlled trial (CRCT).

33 Background: GA evaluates aging-related domains (e.g., function) known to be associated with cancer treatment toxicity. We found that providing a GA summary with management recommendations to oncologists reduces clinician-rated toxicity in older patients (pts) with advanced cancer receiving high risk treatment (presented @ASCO2020). Herein, we report secondary outcomes on the effects of the GA intervention on aging-related outcomes. Methods: Pts aged ≥ 70 with incurable solid tumors or lymphoma and ≥ 1 impaired GA domain starting a new treatment regimen were enrolled. Community oncology practices were randomized to intervention (oncologists received GA summary/recommendations) or usual care (none given). Secondary analyses examined effects of the intervention on functional outcomes (patient-reported falls, instrumental activities of daily living (IADL), short physical performance battery (SPPB), geriatric depression scale (GDS), and medications [total and prescription]). Outcomes were analyzed using linear mixed effects model, logistic or Poisson regression adjusted for baseline values, time, and site effects as appropriate. Results: From 2013-19, 718 pts were enrolled from 41 practices. Age (mean 77 yrs), sex (43% women), number of impaired GA domains (median 4/8), and treatment type (chemotherapy 88%) were not different by arm. More pts in intervention were black (12% vs 3%, p&lt;0.01), had GI cancer (38% vs 31%, p&lt;0.01), and had prior chemotherapy (31% vs 23%, p=0.02). Overall, 16.4% of all pts had one new fall over 3 months; patients in the intervention arm were significantly less like to fall over 3 months (11.7% vs 20.7%; Risk Ratio 0.58; 95% CI 0.40-0.84, p=0.004). There was no difference in the total number of medications (mean 5.86 vs 5.79, p=0.80) and prescriptions (mean 4.26 vs 4.20, p=0.70) at baseline. More medications (adjusted mean 0.23 vs 0.09, p=0.03) and prescriptions (0.19 vs 0.07, p=0.05) were discontinued during intervention, although there was no difference at 3 month follow up. There were no significant between-arms differences in IADL, SPPB, and GDS. Conclusions: Providing GA information to oncologists reduces the proportion of older pts who experience a fall over 3 months and improves polypharmacy; both of these endpoints are of clinical importance to older adults with aging-related conditions and advanced cancer undergoing palliative treatment. Funding: R01CA177592, U01CA233167, UG1CA189961. Clinical trial information: NCT02054741 .

Capacity to Provide Geriatric Specialty Care for Older Adults in Community Oncology Practices

American Society of Clinical Oncology guidelines recommend that patients ≥65 years of age starting chemotherapy undergo a geriatric assessment (GA) to inform and guide management; however, little is known about resources available in community oncology practices to implement these guidelines and to facilitate geriatric oncology research. Oncology practices within the National Cancer Institute Community Oncology Research Program (NCORP) were electronically surveyed in 2017 regarding the availability of specialty providers, supportive services, and practice characteristics, as part of a larger survey of cancer care delivery research capacity. Of the 943 NCORP practices, 504 (54%) responded to the survey, representing 210 practice groups. The median new cancer cases per year ≥65 years of age was 457 (interquartile range 227-939). Of respondents, only 2.0% of practices had a fellowship-trained geriatric oncologist on staff. Geriatricians were available for consultation or comanagement at 37% of sites, and of those, only 13% had availability within the oncology clinic (5% of overall). Practice size of ≥1,000 new adult cancer cases (ages ≥18) per year was associated with higher odds (1.81, confidence interval 1.02-3.23) of geriatrician availability. Other multidisciplinary care professionals that could support GA were variably available onsite: social worker (84%), nurse navigator (81%), pharmacist (77%), dietician (71%), rehabilitative medicine (57%), psychologist (42%), and psychiatrist (37%). Only a third of community oncology practices have access to a geriatrician within their group and only 5% of community sites have access within the oncology clinic. Use of primarily self-administered GA tools that direct referrals to available services may be an effective implementation strategy for guideline-based care. Only a minority of community oncology practices in the U.S. have access to geriatric specialty care. Developing models of care that use patient-reported measures and/or other geriatric screening tools to assess and guide interventions in older adults, rather than geriatric consultations, are likely the most practical methods to improve the care of this vulnerable population.

Abstract 4352: Fostering research participation through NCI's Cancer Moonshot Biobank engagement portal

Abstract Patients and healthcare providers are important partners in cancer biobanking and research. Until now, however, there have been a limited number of scalable approaches to engage patients and providers as true collaborators in biobanking studies. The National Cancer Institute's Cancer Moonshot Biobank is a new engagement-centered project whose goal is to accelerate cancer research on drug resistance and sensitivity. This ambitious undertaking will involve the collection and distribution of longitudinal cancer biospecimens from over 1000 research participants receiving standard of care therapy at participating NCI Community Oncology Research Program (NCORP) institutions. Participants will be asked to donate blood and tissue at various time points including at baseline, during treatment, and at progression, if applicable. Engagement is a core component of the project given the longitudinal nature of the project, and the importance of participants and providers to its success. We define engagement as the establishment of an ongoing trusting and mutually vested relationship between study participants, healthcare providers and the Biobank. The three main engagement components of the Cancer Moonshot Biobank are: 1. External Scientific Panel (ESP): An extramural team of physicians, patient advocates, communication and biobanking experts who give input on various aspects of Biobank engagement 2. Local engagement activities at NCORP Sites 3. An online Participant and Provider Engagement (PPE) portal The PPE portal will be the main platform for direct interface between the Biobank and its participants, healthcare providers, as well as the public, and will serve as an archetype within NCI for the development of a unified portal for future NCI projects. Through the PPE portal, participants and providers will receive program updates, securely access documents including their biomarker test results and signed consent forms, and access educational material and other community resources. We describe ideation, design, and content creation for the PPE portal. Strategies for usability testing, integration of feedback, procedures for design and content iteration, as well as lessons learned are also discussed. Through the creation of NCI's PPE portal we aim to provide a valuable resource to participants and providers who are part of the Cancer Moonshot Biobank, while at the same time facilitating adoption of online engagement strategies within NCI and beyond. Citation Format: Esmeralda Casas-Silva, Helena J. Ellis, Veena Gopalakrishnan, Carol J. Weil, Abhi Rao, Lokesh Agrawal, Ping Guan, Natalie Madero, Jane W. Wanyiri, Jeffrey McLean, Mark A. Jensen, James Suh, Sean McDermott, P. Mickey Williams, Helen M. Moore, Laura Kadamus, Ainsley Adao, Rhett Beattie, Frank Ali, Debapriya Sarkar. Fostering research participation through NCI's Cancer Moonshot Biobank engagement portal [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 4352.

Abstract IA01: How the National Cancer Institute is working to reduce cancer health disparities

Abstract Disparities in cancer incidence and mortality among members of racial/ethnic minority groups continue to be a daunting public health challenge. While cancer disparities have been well documented, further efforts are needed to understand the factors that cause these disparities and to develop interventions. The National Cancer Institute (NCI) has had programs dedicated to addressing disparities for more than two decades, which now pursue a multipronged approach. Among the most recent NCI efforts is a stipulation included in all Cancer Moonshot funding opportunities that requires applicants to include information on how they will integrate data on populations affected by disparities or data on these populations into the proposed study. The Cancer Moonshot also includes specific disparities-related components, including those to fund the development of preclinical research models and screening programs that target specific racial/ethnic populations. More longstanding NCI efforts include those supporting a portfolio of studies, from basic to translational, that are unmasking biologic, socioeconomic, and cultural factors that contribute to disparities and identifying ways to directly address those factors through precision medicine and other approaches. Recent examples include the RESPOND study, which is focused on better understanding prostate cancer disparities in African American men. Other NCI programs are aimed at increasing the participation of people who are members of racial/ethnic minority groups in clinical studies, including innovative precision medicine studies. These include the NCI Community Oncology Research Program and the Partnerships to Advance Cancer Health Equity program that supports collaborations among institutions that serve large underserved populations and NCI-designated Cancer Centers. NCI also supports programs intended to improve the participation of under-represented populations in the cancer research and clinical workforce. This is helping to ensure that people from varied backgrounds can contribute their viewpoints and experiences to the cancer research enterprise and further deepen the talent pool from which research institutions can draw. From a clinical perspective, improving the diversity of clinicians/researchers can also improve trust among patients from racial/ethnic minority groups, which in turn can help increase the likelihood that these patients will consider participating in clinical studies. NCI programs that are helping to improve the diversity of the cancer workforce include the Continuing Umbrella of Research Experiences (CURE) that supports extramural research training and educational experiences for underrepresented individuals beginning in middle school and continuing through to first academic appointments through individual (F31 and K awards) and institutional (R25) grants, as well as the iCURE program that provides mentored research experiences within the NCI Intramural Research Program for students and fellows. Additional awards aid early-stage investigators in establishing themselves as independent investigators in the laboratory and clinical settings (R37, K23) and promote workforce diversity in basic cancer research (R21). Citation Format: Norman E. Sharpless. How the National Cancer Institute is working to reduce cancer health disparities [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr IA01.

Design, data linkage, and implementation considerations in the first cooperative group led study assessing financial outcomes in cancer patients and their informal caregivers

BackgroundFew studies have assessed the financial impact of cancer diagnosis on patients and caregivers in diverse clinical settings. S1417CD, led by the SWOG Cancer Research Network, is the first prospective longitudinal cohort study assessing financial outcomes conducted in the NCI Community Oncology Research Program (NCORP). We report our experience navigating design and implementation barriers. MethodsPatients age ≥ 18 within 120 days of metastatic colorectal cancer diagnosis were considered eligible and invited to identify a caregiver to participate in an optional substudy. Measures include 1) patient and caregiver surveys assessing financial status, caregiver burden, and quality of life and 2) patient credit reports obtained from the credit agency TransUnion through a linkage requiring social security numbers and secure data transfer processes. The primary endpoint is incidence of treatment-related financial hardship, defined as one or more of the following: debt accrual, selling or refinancing home, ≥20% income decline, or borrowing money. Accrual goal was n = 374 patients in 3 years. ResultsS1417CD activated on Apr 1, 2016 and closed on Feb 1, 2019 after reaching its accrual goal sooner than anticipated. A total of 380 patients (median age 59.7 years) and 155 caregivers enrolled across 548 clinical sites. Credit data were not obtainable for 76 (20%) patients due to early death, lack of credit, or inability to match records. ConclusionsRobust accrual to S1417CD demonstrates patients' and caregivers' willingness to improve understanding of financial toxicity despite perceived barriers such as embarrassment and fears that disclosing financial status could influence treatment recommendations.

A qualitative study of barriers and facilitators to enrollment of adolescents and young adults onto cancer clinical trials at NCI community oncology research program (NCORP) sites.

e19050 Background: Cancer clinical trials (CCTs) contribute to improving patient survival and quality of life; however, adolescents and young adults (AYAs, 15-39 years old), are underrepresented in CCTs, especially in the community setting. We aimed to identify barriers and facilitators to AYA CCT enrollment in the NCORP. Methods: We conducted 43 one-on-one semi-structured qualitative interviews with key stakeholders involved in the enrollment of AYAs across a diverse group of NCORP primary (n = 5) and affiliate (n = 10) sites. Interviews were conducted remotely by 3 trained interviewers using the Zoom platform. Stakeholders were recruited from high and low AYA enrolling sites (AYA/total site enrollments &gt; 10% and &lt; 3%, respectively). Stakeholders were overall NCORP Site PIs (n = 5), lead NCORP administrators (n = 4), clinical research associates (n = 11), medical and pediatric oncologists involved in the enrollment of AYAs (n = 7), regulatory research associates (n = 5), nurse navigators (n = 6), and patient advocates (n = 5). Interviews were audiotaped and transcribed. Thematic analysis was conducted to identify themes and relate them back to our primary research questions regarding barriers and facilitators to AYA CCT enrollment. Results: Stakeholder views on enrollment barriers centered on 5 main themes: (1) lack of site-level prioritization or discussion of AYA enrollment; (2) limited number of clinical trials for AYAs available nationally, with few trials opened locally; (3) insufficient resources and research staff; (4) concerns about the cost effectiveness of opening AYA trials due to low numbers of eligible patients; and (5) patient misconceptions about CCTs. Stakeholder views on enrollment facilitators centered on 3 main themes: (1) presence of an AYA program focused on increasing enrollment; (2) having a designated site AYA “champion”; and (3) having site leadership identify AYA enrollment as a priority. Stakeholders agreed that incentivizing AYA enrollments via increased reimbursement and/or study credits could potentially lead to increased enrollment. Conclusions: In addition to identifying multiple shared barriers to AYA CCT enrollment, our study also identified possible interventions for enrollment improvement, including designation of AYA “champions”, increased reimbursement for AYA enrollments, and improving AYA’s understanding of CCTs. Further studies are needed to assess the impact of interventions aimed at increasing AYA enrollment across the NCORP.

A geriatric assessment (GA) intervention to reduce treatment toxicity in older patients with advanced cancer: A University of Rochester Cancer Center NCI community oncology research program cluster randomized clinical trial (CRCT).

12009 Background: GA evaluates aging-related domains (e.g., function) known to be associated with cancer treatment toxicity. In this CRCT, we evaluated if providing a GA summary with management recommendations to oncologists can reduce toxicity in older patients (pts) with advanced cancer receiving chemotherapy and/or other agents with a high reported prevalence of grade 3-5 toxicity. Methods: Pts aged &gt; 70 with incurable solid tumors or lymphoma and &gt; 1 impaired GA domain starting a new treatment regimen were enrolled. Community oncology practices were randomized to intervention (oncologists received GA summary/recommendations for impairments) or usual care (none given). The primary outcome was proportion of pts who experienced any grade 3-5 toxicity (CTCAE v.4) within 3 months. Practice staff prospectively captured toxicities; blinded oncology clinicians reviewed medical records to verify. Secondary outcomes included 6 month overall survival (OS) and treatment intensity (standard vs reduced). Outcomes were analyzed using generalized linear mixed/Cox models with Arm as a fixed effect, controlling for practice. Results: From 2013-19, 718 pts were enrolled from 41 practices. Age (mean 77 yrs), sex (43% women), number of impaired GA domains (median 4/8), and treatment type (chemotherapy 88%) were not different by Arm. More pts in intervention were Black (12% vs 3%, p&lt;0.01), had GI cancer (38% vs 31%, p&lt;0.01), and had prior chemotherapy (31% vs 23%, p=0.02). Pts in intervention experienced a lower proportion of grade 3-5 toxicity (175/349; 50%) than pts in usual care (262/369; 71%). The relative risk (RR: intervention vs usual care) of grade 3-5 toxicity was 0.74 (95% CI: 0.63-0.87; p=0.0002); the difference was mostly driven by non-heme toxicities (RR 0.73; 95% CI: 0.53-1.0, p&lt;0.05). OS was not significantly different (71% vs 74%, p=0.3). More pts in intervention received reduced intensity treatment at cycle 1 (49% vs 35%, RR 0.81, p=0.01). Dose modifications due to toxicity were lower in intervention (42% vs 58%, p&lt;0.0001), but results were not significant after controlling for practice (RR 0.85; 95% CI: 0.67-1.08, p=0.2). Conclusions: Providing GA information to oncologists reduces the proportion of older pts who experience grade 3-5 toxicity from high-risk palliative cancer treatment, without compromising OS. Reduced treatment intensity at cycle 1 may explain these results. Funding: R01CA177592, U01CA233167, UG1CA189961. Clinical trial information: NCT02054741 .

Effects of YOCAS yoga, cognitive behavioral therapy, and survivorship health education on insomnia: A URCC NCORP Research Base Phase III RCT in 740 cancer survivors.

12005 Background: Insomnia, a prevalent and troublesome side effect experienced by cancer survivors, significantly impairs recovery and survival. We conducted a nationwide, multicenter, phase III, blinded, randomized controlled trial testing whether 1) yoga is superior to survivorship health education (SHE) and 2) yoga is non-inferior to cognitive behavioral therapy for insomnia (CBT-I) for treating insomnia in survivors. Methods: The trial was conducted via the University of Rochester Cancer Center NCI Community Oncology Research Program (URCC NCORP) Research Base. Participants were cancer survivors between 2-60 months post adjuvant therapy, with insomnia, no metastatic disease, and no yoga participation during the previous 3 months. Survivors were randomized into 1) YOCAS yoga (2x/wk; 75 min/sess for 4 wks with pranayama, asana, and dhyana, N = 251), 2) CBT-I (1x/wk, 90 min/sess for 8 wks with sleep hygiene, stimulus control, sleep restriction, and cognitive therapy, N = 238), or 3) SHE (2x/wk; 75 min/sess for 4 wks with ASCO-recommended survivorship education, N = 251). Insomnia was assessed pre- and post-intervention via the Insomnia Severity Index. Results: 740 eligible cancer survivors were enrolled (93% female, mean age = 56 + 11, 75% breast cancer). ANCOVAs with baseline values as covariates revealed YOCAS is significantly better than SHE for treating insomnia at post-intervention (CS = change score; CS mean diff = -1.43, SE = 0.42, p &lt; 0.01). Yoga participants demonstrated greater improvements in insomnia from pre- to post-intervention (CS = -3.61, SE = 0.30) compared to SHE participants (CS = -2.19, SE = 0.33, all p &lt; 0.01). Intent-to-treat analyses of non-inferiority (non-inferiority margin set at 1.15 a priori) showed YOCAS is inferior to CBT-I (CS mean diff = 3.52, CI = 2.55 - 4.50, p &lt; 0.01). However, analyses of non-inferiority using the optimal treatment effect in fully compliant survivors were inconclusive regarding whether YOCAS is non-inferior to CBT-I for treating insomnia (CS mean diff = 2.20, CI = 0.42 - 3.98, p = 0.09). Significantly more survivors withdrew from CBT-I and SHE due, in part, to disliking the interventions compared to YOCAS (30%, 25%, and 16%, respectively, p &lt; 0.01). Conclusions: YOCAS yoga is better than SHE and results are inconclusive as to whether yoga is non-inferior to CBT-I for treating insomnia among survivors. Clinicians should consider prescribing YOCAS and CBT-I for survivors reporting insomnia. Funding: NCI UG1CA189961, R01CA181064, T32CA102618. Clinical trial information: NCT02613364 .

Randomized trial of web-based genetic education versus usual care in advanced cancer patients undergoing tumor genetic testing: Results from the ECOG-ACRIN NCI Community Oncology Research Program (NCORP; EAQ152) COMET trial.

2008 Background: Enthusiasm for precision oncology may obscure the complex psychosocial and ethical considerations for tumor genetic testing. Low patient genetic knowledge has been documented and heightens the risk for adverse experiences. We developed a web-based intervention to increase genetic knowledge and decrease distress among advanced cancer patients undergoing tumor genetic testing. Methods: 594 patients (80% from NCORP Community Sites) were recruited and randomized to web-intervention (n = 293) or usual care (n = 301), prior to receipt of tumor genetic test results. Primary outcomes were genetic knowledge, anxiety, depression, and cancer-specific distress measured at T0 (prior to intervention), T1 (post-intervention), T2 (after receipt of tumor results) and T3 (3 months post receipt of tumor results). Secondary outcomes included satisfaction, regret and disappointment. The effect of web-intervention was evaluated using t-test, multiple linear regression and logistic regression, with an intent-to-treat approach. Results: Patients randomized to web-intervention had better knowledge improvement than those randomized to usual care (T1-T0, p &lt; 0.0001; T2-T0, p = 0.003). No difference was observed in change scores for anxiety, depression or cancer-specific distress. To find the moderators of intervention effect (including sex, age, education, and literacy) two 2-way interactions were noted with statistical significance: higher depression among those in the intervention arm versus the control arm for patients with lower literacy (p = 0.03); and lower cancer-specific distress among women in the intervention arm than with usual care but no such effect noted in men (p = 0.01). 71% of patients reported receiving tumor test results and this did not differ by arm. Only 20% of patients reported regret and disappointment at T2, which was more likely for those without a mutation of interest (MOI) detected vs those with a MOI detected (OR = 2.08, 95% CI, 1.13 to 3.83, p = 0.02). Conclusions: Web-based education prior to receipt of tumor genetic test results increases patient understanding of tumor genetic testing. While the intervention did not significantly reduce distress, results suggest that women who received the intervention had lower cancer-specific distress than those with usual care. Future refinements to the web-intervention are needed to address low literacy groups, men and patients with no actionable results. Clinical trial information: NCT02823652.

Decision aids for localized prostate cancer: Initial outcomes from NCI Community Oncology Research Program Alliance Research Base Cancer Care Delivery Research (CCDR) Protocol - A191402CD - A Cluster-Randomized Trial.

e24176 Background: Decision aids for prostate cancer treatment can improve knowledge, but the relative effect of pre-consultation and within-consultation DAs is not known. Methods: We conducted a parallel design, 2-by-2 factorial, 4-arm, cluster-RCT in urology practices affiliated with the NCI’s Alliance research base. We compared patient knowledge immediately after consultation (%12-item% correct) intervention arms compared to usual care. We used mixed effects regression modeling to assess effect of interventions on knowledge adjusting for site-clustering, race/ethnicity (non-Hispanic White; Other), age (years), clinical stage (T1-3), PSA, and Gleason score. Results: 15 of 21 randomized centers accrued 158 pts from Nov 2017 to June 2019. The arm delivering both DAs (n = 3 sites) recruited 25 pts. The pre-consultation DA arm (n = 4 sites) recruited 39 pts. The within-consultation DA arm (n = 4 sites) recruited 44 pts. The no DA arm (n = 4 sites) accrued 50 pts. Overall, mean age was 64; 54% were AA; 73% had T1 stage; median Gleason = 7; and median PSA = 7. The combined DAs group, followed by pre-consultation reported higher median knowledge (75% and 67%, respectively). The within-consultation and no DA arms both reported median knowledge scores (58%). Within arm, inter-site standard deviations in mean knowledge scores ranged from 0.164 in in the pre-consultation arm to 0.232 in the usual care arm. Neither pre-consultation nor within-consultation DAs had statistically significant effects (p = .15 and p = .99, respectively). Pre-specified adjusted difference [97.5% CIs], comparing the pre-consultation DA and the within-consultation DA with the control was 9.4% [-7.3%, 26.2%] and -0.4% [-16.9%, 16.1%], respectively. Intra-cluster correlation (ICC) coefficient was high (.24). No interaction effects were identified (p = .98). A post-hoc analysis comparing any DA vs usual care found a mean adjusted difference [95% CI] of 5.6% [-8.5%, 19.8%] (p = 0.40), 63.9% for any DA and 58.3% for usual care. Conclusions: Possible knowledge gains associated with some DAs for early prostate cancer were obscured by larger-than-expected intra-cluster correlation effects associated with the primary outcome. How interventions were used was not measured. Support:UG1CA189823; https://acknowledgments.alliancefound.org ; R01 MD008934-06. Clinical trial information: NCT03103321 .