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People experiencing financial burden are underrepresented in clinical trials.Describe the prevalence of cost-related considerations influential to trial participation and their associations with person-level characteristics.This cross-sectional study used and assessed how three cost-related considerations would influence the decision to participate in a hypothetical clinical trial.A total of 3682 US adult respondents to the Health Information National Trends Survey MAIN MEASURES: Survey-weighted multivariable logistic regression estimated associations between respondent characteristics and odds of reporting cost-related considerations as very influential to participation.Among 3682 respondents, median age was 48 (IQR 33-61). Most were non-Hispanic White (60%), living comfortably or getting by on their income (74%), with ≥ 1 medical condition (61%). Over half (55%) of respondents reported at least one cost-related consideration as very influential to trial participation, including if usual care was not covered by insurance (reported by 42%), payment for participation (24%), or support for participation (24%). Respondents who were younger (18-34 vs. ≥ 75, adjusted odds ratio [aOR] 4.3, 95% CI 2.3-8.1), more educated (high school vs.high school, aOR 2.1, 95% CI 1.1-4.1), or with lower perceived income (having difficulty vs. living comfortably, aOR 2.1, 95% CI 1.1-3.8) had higher odds of reporting any cost-related consideration as very influential to trial participation. Non-Hispanic Black vs. non-Hispanic White respondents had 29% lower odds (95% CI 0.5-0.9) of reporting any cost-related consideration as very influential to trial participation.Cost-related considerations would influence many individuals' decisions to participate in a clinical trial, though prevalence of these concerns differed by respondent characteristics. Reducing financial barriers to trial participation may promote equitable trial access and greater trial enrollment diversity.

Improvements in cancer care delivery have the potential to reduce morbidity and mortality from cancer, however, challenges to delivery of recommended care limit progress. These challenges include growing demands for care, increasing treatment complexity, inadequate care coordination, dramatic increases in costs, persistent disparities in care, and insufficient use of evidence-based guidelines. Recognizing the important role of research in understanding and addressing these challenges, the National Cancer Institute created the Healthcare Delivery Research Program (HDRP) in 2015 as a catalyst for expanding work in this area. Health-care delivery research is a multidisciplinary effort which recognizes that care delivery occurs in a multilevel system encompassing individuals, health-care systems, and communities. HDRP staff use a range of activities to fulfill the program’s mission of advancing innovative research to improve delivery of care across the cancer control continuum. In addition to developing funding opportunities, HDRP staff; support and facilitate the use of research infrastructure for conducting health-care delivery research; oversee publicly available data that can be used to evaluate patterns, costs, and patient experiences of care; contribute to development and dissemination of standardized health measurement tools for public use; and support professional development and training to build capacity within the field and grow the workforce. As HDRP enters its sixth year, we appreciate the opportunity to reflect on the program’s progress in advancing the science of health-care delivery. At the same time, we recognize the need for the program to evolve and develop additional resources and opportunities to address new and emerging challenges.

With increased attention to the financing and structure of healthcare, dramatic increases in the cost of diagnosing and treating cancer, and corresponding disparities in access, the study of healthcare economics and delivery has become increasingly important. The Healthcare Delivery Research Program (HDRP) in the Division of Cancer Control and Population Sciences at the National Cancer Institute (NCI) was formed in 2015 to provide a hub for cancer-related healthcare delivery and economics research. However, the roots of this program trace back much farther, at least to the formation of the NCI Division of Cancer Prevention and Control in 1983. The creation of a division focused on understanding and explaining trends in cancer morbidity and mortality was instrumental in setting the direction of cancer-related healthcare delivery and health economics research over the subsequent decades. In this commentary, we provide a brief history of health economics and healthcare delivery research at NCI, describing the organizational structure and highlighting key initiatives developed by the division, and also briefly discuss future directions. HDRP and its predecessors have supported the growth and evolution of these fields through the funding of grants and contracts; the development of data, tools, and other research resources; and thought leadership including stimulation of research on previously understudied topics. As the availability of new data, methods, and computing capacity to evaluate cancer-related healthcare delivery and economics expand, HDRP aims to continue to support this growth and evolution.

Background Accrual to cancer clinical trials is suboptimal. Few data exist regarding whether financial reimbursement might increase accruals. Objective The objective of this study was to assess perceptions about reimbursement to overcome barriers to trial accrual. Research design This was a cross-sectional survey. Subjects Oncologists identified from the American Medical Association Physician Masterfile. Measures We report descriptive statistics, associations of physician characteristics with perceptions of reimbursement, domains, and subthemes of free-text comments. Results Respondents (n=1030) were mostly medical oncologists (59.4%), ages 35-54 (67%), and male (75%). Overall, 30% reported discussing trials with >25% of patients. Barriers perceived were administrative/regulatory, physician/staff time, and eligibility criteria. National Cancer Institute cooperative group participants and practice owners were more likely to endorse higher reimbursement. Respondents indicated targeted reimbursement would help improve infrastructure, but also noted potential ethical problems with reimbursement for discussion (40.7%) and accrual (85.9%). Free-text comments addressed reimbursement sources, recipients, and concerns about the real and apparent conflict of interest. Conclusions Though concerns about a potential conflict of interest remain paramount and must be addressed in any new system of reimbursement, oncologists believe reimbursement to enhance infrastructure could help overcome barriers to trial accrual.

Cancer health care disparities are complex, involve patient, clinician and health care system factors, and are defined as adverse differences in cancer outcomes. This analysis describes NCI's Healthcare Delivery Research Program's (HDRP) portfolio of disparities-focused research and identifies future research opportunities. Grants through HDRP (fiscal years 2012 to 2016) focused on detecting, understanding, and/or intervening on disparities in or among health disparity populations were reviewed by co-authors. Forty-eight funded grants were identified, coded, and characterized. Descriptive analyses are reported. Most studies focused on racial/ethnic minorities and socioeconomically disadvantaged groups. Colorectal, breast, and cervical cancers were most frequently examined. Almost 40% of studies addressed the intervening phase of the disparities research continuum. Few studies focused on clinician-level factors or involved the community in the research design. A sustained disparities research emphasis is essential to addressing the determinants of and cancer burden among health disparity populations across the cancer care continuum.

Organizational characteristics, including organizational structures and processes, are important to understanding care delivery and health outcomes. However, organizational-level constructs present measurement challenges in care delivery research. This analysis aims to understand if, when, and how organizational characteristics are examined in a National Cancer Institute (NCI) research network conducting cancer care delivery research (CCDR). The NCI Community Oncology Research Program encourages consideration of organizational variables in CCDR studies. We conducted a cross-sectional thematic analysis to identify organizational characteristics examined in this portfolio of research. Organizational characteristics targeted, related measures, and analytic approach were abstracted by 2 study investigators using a coding framework adapted from 2 existing frameworks. A total of 78.9% of eligible study protocols included organizational characteristics. Structural characteristics were the most common, collected in all 15 included protocols, 14 examined at least 1 organizational process, and 12 examined organizational-level outcomes. Most studies proposed descriptive practice-level analyses or multilevel analyses using random effects to account for clustering of patients and staff within practices. Few (n = 5) specified that organizational variables would be modeled as effects of interest (vs covaried out) or proposed analytic approaches that could more robustly examine effects of targeted organizational characteristics on primary outcomes. Inclusion of organizational variables is common in CCDR conducted through the NCI Community Oncology Research Program, NCI’s national network charged with bringing cancer clinical trials to people in their communities. Nonetheless, opportunities remain to improve the use of theory to guide organizational construct selection, operationalization, measurement, and incorporation into study hypotheses and analyses.

Over a decade ago, the National Academy of Medicine (NAM) recommended that states develop, implement, and evaluate plans that include consideration of survivorship care. The purpose of this study was to review comprehensive cancer control plans in the USA, specifically to identify the inclusion of cancer survivorship-focused goals and objectives and examine alignment of survivorship-focused objectives with the NAM recommendations. Plans from 50 states, 7 territories, 5 tribal organizations, and the District of Columbia were reviewed to assess inclusion of survivorship goals and objectives. One territory plan was excluded because it did not include a survivorship-focused goal or objective (final n = 62). Objectives were assigned to domains based on NAM survivorship recommendations. Plans included between 1 and 19 survivorship-related objectives. Of the 345 survivorship objectives extracted and analyzed, the most prevalent domains addressed were raising awareness, survivorship care plans, healthcare professional capacity, and models of coordinated care. Employment-related concerns, developing and implementing quality measures, and investments in research were not frequently included in objectives. Comprehensive cancer control plans represent an important strategy that may reduce the impact of cancer and its treatment. State, territorial, and tribal coalitions can use these results to systematically focus future survivorship efforts on areas relevant to their region and population. The growing number of survivors requires broad-ranging policy strategies. Future efforts are needed to assess the implementation and impact of plan strategies to improve the overall wellness of cancer survivors.

Sexual and gender minorities (SGMs) face a disproportionate burden of cancer, yet little is known about the experiences and specific needs of these underserved populations in cancer care delivery. The authors conducted a scoping review to characterize the literature on cancer care delivery, health outcomes, and health care experiences for patients with cancer and survivors identifying as SGM. In total, 1176 peer-reviewed citations were identified after a systematic search of the PubMed/Medline, PsycInfo, Cumulative Index of Nursing and Allied Health Literature (CINAHL), and Web of Sciences databases without restriction on publication date. The details captured included study aims, design, population, cancer site, and main findings. Thirty-seven studies published from 1998 to 2017 met the study criteria. Most studies were conducted in the post-treatment survivorship phase of the continuum (n = 30), and breast cancer was the most common cancer site (n = 20). There were only 2 intervention studies. The studies reviewed were classified under the following areas of focus: 1) disclosure of sexual orientation and gender identity, 2) quality of care, 3) psychosocial impact of/ adjustment to cancer, 4) social support, 5) sexual functioning, and 6) health risks/health behavior. Very little research reported an assessment of gender minority status or included a focus on gender minorities (n = 7). This review revealed substantial research gaps given a lack of population-based data and small sample sizes, likely related to the absence of systematic collection of sexual orientation and gender identity information in the cancer care context. Deficient research in this area likely perpetuates health disparities. Further research is needed to identify and remove the barriers to delivering high-quality care to SGM individuals with cancer.

There are now close to 17 million cancer survivors in the United States, and this number is expected to continue to grow. One decade ago the Institute of Medicine report, From Cancer Patient to Cancer Survivor: Lost in Transition, outlined 10 recommendations aiming to provide coordinated, comprehensive care for cancer survivors. Although there has been noteworthy progress made since the release of the report, gaps remain in research, clinical practice, and policy. Specifically, the recommendation calling for the development of quality measures in cancer survivorship care has yet to be fulfilled. In this commentary, we describe the development of a comprehensive, evidence-based cancer survivorship care quality framework and propose the next steps to systematically apply it in clinical settings, research, and policy.

176 Background: Improving the delivery and outcomes of cancer care should be informed by research that aims to reduce disparities among underserved populations and those underrepresented in clinical studies. The NCI Community Oncology Research Program (NCORP), a community-based clinical trials network, conducts such research. In this analysis, we aimed to identify opportunities to develop a robust program of disparities-relevant cancer care delivery research (CCDR). Methods: We reviewed NCORP CCDR studies approved between August 2014-May 2022. Any study with at least one aim addressing care delivery in NIH-health disparity or underrepresented populations was deemed disparities-relevant. Studies were categorized as: primary if they were focused exclusively on cancer disparities within populations of interest; secondary if they had a disparities-related aim in a broader study; and exploratory if the aim assessed differences by race, ethnicity, income, insurance status, or practice-level characteristics. For each CCDR protocol, study and disparities-related characteristics were abstracted by two reviewers, who resolved any disagreements by discussion. Descriptive statistics are summarized. Results: Of 23 CCDR studies, a majority had at least one disparities-relevant aim: 4 primary, 3 secondary, and 10 exploratory. Studies with primary and secondary aims focused on racial/ethnic minorities, rural residents, older adults, adolescent/young adults and socioeconomically disadvantaged populations. Cancer care delivery gaps addressed by these studies included shared decision making, guideline adherence, case management, healthcare expenditures, and healthcare accessibility. Most studies focused on patients undergoing active treatment and included multilevel interventions. Only one of the disparities-relevant studies was available to non-English speaking patients. Conclusions: The inclusion of disparities-relevant aims in most of the care delivery studies is encouraging. The fact that most studies with a primary or secondary aim included an intervention demonstrates strong interest in generating evidence that will support improved cancer care delivery. Studies also addressed several distinct disparity populations across a range of care delivery gaps. These results represent opportunities for targeted network efforts to increase the disparities research portfolio and may inform strategies to optimize equitable care delivery that meets the needs of diverse cancer patient/survivor populations.

Background Cancer Centers have a responsibility to help patients manage the costs of their cancer treatment. This article describes the availability of financial navigation services within the National Cancer Institute (NCI)-Designated Cancer Centers. Methods Data were obtained from the NCI Survey of Financial Navigation Services and Research, an online survey administered to NCI-Designated Cancer Centers from July to September 2019. Of the 62 eligible Centers, 57 completed all or most of the survey, for a response rate of 90.5%. Results Nearly all Cancer Centers reported providing help with applications for pharmaceutical assistance programs and medical discounts (96.5%), health insurance coverage (91.2%), assistance with non-medical costs (96.5%), and help understanding medical bills and out-of-pocket costs (85.9%). Although other services were common, in some cases they were only available to certain patients. These services included direct financial assistance with medical and non-medical costs and referrals to outside organizations for financial assistance. The least common services included medical debt management (63.2%), detailed discussions about the cost of treatment (54.4%), and guidance about legal protections (50.1%). Providing treatment cost transparency to patients was reported as a common challenge: 71.9% of Centers agreed or strongly agreed that it is difficult to determine how much a cancer patient’s treatment will cost and 70.2% of oncologists are reluctant to discuss financial issues with patients. Conclusions Cancer Centers provide many financial services and resources. However, there remains a need to build additional capacity to deliver comprehensive financial navigation services and to understand the extent to which patients are referred and helped by these services.

Over a decade ago, the National Academy of Medicine (NAM) recommended that states develop, implement, and evaluate plans that include consideration of survivorship care. The purpose of this study was to review comprehensive cancer control plans in the USA, specifically to identify the inclusion of cancer survivorship-focused goals and objectives and examine alignment of survivorship-focused objectives with the NAM recommendations.Plans from 50 states, 7 territories, 5 tribal organizations, and the District of Columbia were reviewed to assess inclusion of survivorship goals and objectives. One territory plan was excluded because it did not include a survivorship-focused goal or objective (final n = 62). Objectives were assigned to domains based on NAM survivorship recommendations.Plans included between 1 and 19 survivorship-related objectives. Of the 345 survivorship objectives extracted and analyzed, the most prevalent domains addressed were raising awareness, survivorship care plans, healthcare professional capacity, and models of coordinated care. Employment-related concerns, developing and implementing quality measures, and investments in research were not frequently included in objectives.Comprehensive cancer control plans represent an important strategy that may reduce the impact of cancer and its treatment. State, territorial, and tribal coalitions can use these results to systematically focus future survivorship efforts on areas relevant to their region and population.The growing number of survivors requires broad-ranging policy strategies. Future efforts are needed to assess the implementation and impact of plan strategies to improve the overall wellness of cancer survivors.

1527 Background: Patient accrual for cancer clinical trials is suboptimal. The complexity of applying eligibility criteria and enrolling patients may deter oncologists from recommending patients for a trial. As such, there is a need to understand how experience, training, and clinical decision support impact physician practices and intentions related to trial accrual. Methods: From May to September 2017, we conducted a survey on clinical trial accrual in a national sample of medical, surgical, and radiation oncologists. The 20-minute survey assessed barriers and facilitators to clinical trial accrual, including experience (e.g., “In the past 5 years, have you been a study or site PI of a trial?”), training (e.g., “Did you receive training about trial design and recruitment as part of medical school, residency, or fellowship? After fellowship?”), and clinical decision support (e.g., “What kind of clinical decision support has your practice implemented?). We used logistic regression to identify factors associated with frequency of discussing trials (with ≥25% of patients) and likelihood of recommending a trial to a patient (likely or very likely) in the future. Results: Survey respondents (n = 1,030) were mostly medical oncologists (59%), age 35-54 years (67%), male (74%), and not in academic practice (58%). About 18% of respondents (n = 183) reported discussing trials with ≥25% of their patients, and 80% reported being likely or very likely to recommend a trial to a patient in the future. Prior experience as principal investigator of a trial was associated with both frequency of discussing trials (OR 3.27, 95% CI 2.25, 4.75) and likelihood of recommending a trial in the future (OR 5.22, 95% CI 3.71, 7.34), as was receiving additional training in clinical trials after fellowship (discussion with patients: OR 2.48, 95% CI 1.80, 3.42; recommend in future: OR 1.92, 95% CI 1.37, 2.69). Implementing clinical decision support was not associated with discussing trials with ≥25% of patients (OR 1.12, 95% CI 0.76, 1.67), but was associated with being likely to recommend a trial in the future (OR 1.73, 95% CI 1.11, 2.71). Conclusions: In a national survey of oncologists, we observed differences in physician practices and intention related to clinical trial accrual. Whereas the vast majority (80%) reported being likely or very likely to recommend trials in the future, far fewer (20%) reported discussing trials with their patients within the past 5 years. Implementation of clinical decision support – electronic tools intended to optimize patient care and identification of patient eligibility – was not associated with frequency of past discussion of clinical trials but was associated with recommending a trial in the future. Given the stronger association between experience as a site Principal Investigator and recommending a trial, future research should explore how improving opportunities to lead a clinical trial impact trial accrual.

6565 Background: Patients (pts) with cancer are at increased risk of SARS-CoV-2 infection and severe COVID-19 disease. Longitudinal follow-up is needed to characterize the severity, sequelae and outcomes in pts with cancer who develop COVID-19. Methods: NCCAPS is a prospective, longitudinal study (NCT04387656) aiming to accrue 2,000 pts with cancer undergoing active treatment or prior stem cell transplant for hematologic or solid tumor malignancy. Adult patients are eligible to enroll within 14 days of their first positive SARS-CoV-2 test; pediatric patients may also enroll retrospectively. Clinical data, patient-reported outcomes, blood specimens, and imaging are collected for up to 2 years. This abstract provides initial baseline and 2-month follow-up data. Results: As of Jan 22, 2021, 585 pts (552 adults and 33 pediatric pts) had complete baseline data and of these pts, 215 adults had 2 months of complete follow-up data. 23.4% of adults and 42.4% of pediatric pts were of non-White race and/or Hispanic/Latinx ethnicity. The most common cancer diagnoses were breast (19.6%), lung (9.9%) and multiple myeloma (8.9%) in adults and acute leukemia (AML/ALL; 63.6%) in children. The most recent treatment was chemotherapy in 38.2%, immunotherapy in 9.6%, and radiation in 5.4%. Median time from positive SARS-CoV-2 test to study enrollment was 10.5 days in adults and 18 days in pediatric pts. Preliminary analysis of plasma cytokines will be presented. At enrollment, 84.6% of adults had COVID-19 symptoms. 55.9% reported symptoms 2 weeks after their positive SARS-CoV-2 test; this fell to 39.0% at 1 month and 28.8% at 2 months (see Table). Of the 215 adults with complete data at 2 months, sequelae included pulmonary (n=22, 10%), cardiovascular (n=12, 6%) thromboembolic (n=9, 4%), bleeding (n=9, 4%) and gastrointestinal (n=11, 5%). 144 (67%) reported at least one cancer treatment disruption in the first 2 months, most commonly delayed therapy (n=98; 46%).Of the 348 adults with baseline data and SARS-CoV-2 test date prior to Nov 23, 2020, 6.3% had died (median time from SARS-CoV-2 test to death: 27 days), and 22.1% reported at least one hospitalization for COVID-19. No deaths were reported in the pediatric population. Conclusion: Cancer pts with COVID-19 report ongoing symptoms after acute infection and a substantial number develop sequelae. Cancer treatment disruptions are common in the initial months following SARS-CoV-2 infection. Longer follow-up will inform whether these treatment disruptions are associated with adverse outcomes. Clinical trial information: NCT04387656. [Table: see text]

12009 Background: Older adults are at risk for physical function decline during therapy for AML. Impaired physical function after induction therapy is associated with shorter survival Interventions designed to maintain function may improve treatment outcomes. We piloted a physical activity (PA) intervention among older adults receiving intensive chemotherapy for AML designed to prevent functional decline. Methods: Single institution randomized pilot study of PA vs. usual care. Eligibility included age ≥60 years, newly-diagnosed AML, ambulatory, planned intensive induction chemotherapy. Intervention participants were offered a PA session five days/week tailored daily to symptoms and conditions during the induction hospitalization. Session options were: 1) Standard (ward-based), walking + balance trahining + resistance exercises; 2) Intermediate (room-based), upper-body ergometer + balance training + resistance exercises; 3) Low-intensity (bed-based), upper-body ergometer + resistance exercises. Behavioral counseling sessions to establish PA goals and overcome barriers were conducted weekly during hospitalization and continued monthly by phone for 6 months. Assessment of physical function occurred at baseline, weekly during hospitalization (approximately 4-6 weeks), 3 months, and 6 months. The primary functional outcome of interest was the Short Physical Performance Battery (SPPB; 5 repeat chair stands, gait speed, balance tests; score 0-12 higher indicates better function). Clinically significant change in physical function was defined as ≥1.0 on the SPPB. Proportions of those that declined, remained stable, or improved on the SPPB were compared by group using an exact test for trend. Results: Among 96 eligible patients 70 enrolled (recruitment rate 73%, average participation 3 sessions/week). The mean age was 72.1±6.3 years, 70% were male. Mean baseline SPPB score was 7.0±3.8. In the surviving intention to treat population (N = 66), more intervention participants, compared to controls, maintained or improved their SPPB score (38% vs. 25%) during induction hospitalization (p = 0.278). Among those who achieved remission (N = 42), function was maintained or improved in a greater proportion of intervention participants (55%) compared to controls (23%), p = 0.047. Maintenance or improvement in SPPB from baseline to last follow-up (3 or 6 months post enrollment) was 62% vs 54% for intervention versus control among the intention to treat cohort (N = 50) and 67% vs. 55% among those who achieved remission (N = 40). Conclusions: A symptom adapted PA intervention with behavioral counseling during induction chemotherapy shows promise in preventing clinically meaningful decline in physical function among older adults with AML who achieve remission. Continued maintenance intervention may sustain benefits. Clinical trial information: NCT01519596.

The NCI invests heavily in research resources to serve the research community, including datasets, biospecimen banks, and networks of institutions in which clinical trials and other human subjects research are conducted. These resources often begin as grant-funded infrastructure initiated by scientists based on their own scientific interests, with a subsequent recognition of additional scientific uses. Although converting existing project-specific research activities into research resources may appear efficient in terms of time and financial investment, challenges can arise that undermine this efficiency and jeopardize future use. Here, we describe three challenges in the conversion process: (i) project-based infrastructure versus a research resource for a broader research community; (ii) complexity versus ease of use; and (iii) individual professional goals versus research resource priorities. We use our experience with the NCI-funded Cancer Research Network, particularly the Virtual Data Warehouse, to illustrate each challenge, concluding with strategies to mitigate each one. As studies grow in size and complexity, an ever-increasing volume of data, biospecimens, and human subjects research networks will be available for conversion to resources for scientific questions beyond those originally proposed. Addressing likely challenges thoughtfully can result in a more efficient conversion process and ultimately greater scientific impact.

Cancer health services research is a primary tool for analyzing the association between various factors, cancer health care delivery, and the resultant outcomes. To address disparities strategies must be developed to target factors that are related to differences in care; however, to date, most disparities studies have been descriptive. The primary objective was to describe cancer treatment and survival disparities in community oncology practice patterns found in the National Cancer Institute's population-based Patterns of Care (POC) Study (1987-2017). Secondarily, we compared POC findings to peer-reviewed literature. In POC data, older age was consistently associated with decreased odds of treatment and increased mortality. Interestingly, in contrast to current literature, few POC studies found race/ethnicity significantly predicted disparities. Cancer health disparities are complex; they are multifactorial, differ by cancer site and may wax and wane. The complexity supports the need for deeper understanding and targeted interventions to ensure equitable cancer care and outcomes.

Each year, 70,000 adolescents and young adults (AYAs) between ages 15 and 39 years in the United States are diagnosed with cancer. In 2006, a National Cancer Institute (NCI) Progress Review Group (PRG) examined the state of science associated with cancer among AYAs. To assess the impact of the PRG and examine the current state of AYA oncology research, the NCI, with support from the LIVESTRONG Foundation, sponsored a workshop entitled "Next Steps in Adolescent and Young Adult Oncology" on September 16 and 17, 2013, in Bethesda, Maryland. This report summarizes the findings from the workshop, opportunities to leverage existing data, and suggestions for future research priorities. Multidisciplinary teams that include basic scientists, epidemiologists, trialists, biostatisticians, clinicians, behavioral scientists, and health services researchers will be essential for future advances for AYAs with cancer.

Author(s): Keegan, Theresa HM; Ries, Lynn AG; Barr, Ronald D; Geiger, Ann M; Dahlke, Deborah Vollmer; Pollock, Bradley H; Bleyer, W Archie; National Cancer Institute Next Steps for Adolescent and Young Adult Oncology Epidemiology Working Group | Abstract: BackgroundWith prior reports indicating a lack of progress in survival improvement in older adolescents and young adults (AYAs) aged 15 to 39 years with cancer compared with both younger and older patients with cancer, the current analysis provides an update of survival trends of cancers among AYAs, children, and older adults.MethodsData from the National Cancer Institute Surveillance, Epidemiology, and End Results database for 13 regions were used to ascertain survival trends of the 34 most frequent cancers diagnosed in AYAs compared with children and older adults.ResultsAs of 2002 through 2006, the 5-year relative survival rate for all invasive cancers in AYAs was 82.5% (standard error, 0.2%). In AYAs, 14 cancers demonstrated evidence of a statistically significant improvement in their 5-year relative survival since 1992. Survival improved less in AYAs than in children for acute myeloid leukemia and medulloblastoma. Fourteen cancers had survival improvements that were found to be less in AYAs compared with older adults, including hepatic carcinoma, acute myeloid leukemia, high-grade astrocytoma, acute lymphocytic leukemia, pancreatic carcinoma, low-grade astrocytoma, gastric carcinoma, renal carcinoma, cancer of the oral cavity and pharynx, Hodgkin lymphoma, ovarian cancer, fibromatous sarcoma, other soft tissue sarcoma, and thyroid carcinoma.ConclusionsImprovements in the survival of several cancer types that occur frequently in AYAs are encouraging. However, survival does not appear to be improving to the same extent in AYAs as in children or older adults for several cancers. Further investment in exploring the distinct biology of tumors in this age group, and of their hosts, must be a priority in AYA oncology.

Introduction There is increasing concern regarding the financial burden of cancer on patients and their families. This study presents nationally representative estimates of annual out-of-pocket (OOP) burden among non-elderly cancer survivors and assesses the association between high OOP burden and access to care and preventive service utilization. Methods Using the 2008–2012 Medical Expenditure Panel Survey, 4,271 cancer survivors and 96,780 individuals without a history of cancer were identified, all aged 18–64 years. High annual OOP burden was defined as spending >20% of annual family income on OOP healthcare costs. Associations between high OOP burden and access to care were evaluated with multivariable logistic regression. Analyses were conducted in 2015. Results Compared with individuals without a cancer history, cancer survivors were more likely to report a high OOP burden (4.3% vs 3.4%, p =0.009) in adjusted analyses. High OOP burden was more common among cancer survivors who were poor (18.4%), with either public insurance (7.9%) or uninsured (5.7%), and not working (10.2%). Among cancer survivors, high OOP burden was associated with being unable to obtain necessary medical care (19.2% vs 12.5%, p =0.002), delaying necessary medical care (21.6% vs 13.8%, p =0.002), and lower breast cancer screening rates among age-appropriate women (63.2% vs 75.9%, p =0.02). Conclusions High OOP burden is more common among adults with a cancer history than those without a cancer history. High OOP burden was associated with being unable to obtain necessary medical care, delaying necessary medical care, and lower breast cancer screening rates among women.

Purpose Although the incidence and mortality of colon cancer in the United States has declined over the past two decades, blacks have worse outcomes than whites. Variations in treatment may contribute to mortality differentials. Methods Patients diagnosed with stage III colon cancer were randomly sampled from the SEER program from the years 1990, 1991, 1995, 2000, 2005, and 2010. Patients were categorized as non-Hispanic white (n = 835) or black (n = 384). Treatment data were obtained from a review of the medical records, and these data were verified through contact with the original treating physicians. Log-binomial regression models were used to estimate the association between race and receipt of adjuvant chemotherapy. Effect modification by insurance was assessed with use of single referent models. Results Receipt of adjuvant chemotherapy among both white and black patients increased from the period encompassing the years 1990 and 1991 (white, 58%; black, 45%) to the year 2005 (white, 72%; black, 71%) and then decreased in the year 2010 (white, 66%; black, 57%). There were marked racial disparities in the time period of 1990 to 1991 and again in 2010, with black patients less likely to receive adjuvant chemotherapy as compared with white patients (risk ratio [RR], .82; 95% CI, .72 to .93). For black patients, receipt of adjuvant chemotherapy did not differ across insurance categories (RR for private insurance, .80; 95% CI, .69 to .93; RR for Medicare, .84; 95% CI, .69 to 1.02; and RR for Medicaid, .84; 95% CI, .69 to 1.02), although a larger proportion had Medicaid in all years of the study as compared with white patients. Conclusion The chemotherapy differential narrowed after the time period of 1990 to 1991, but our findings suggest that the disparity reemerged in 2010. Recent decreases in chemotherapy use may be due, in part, to the economic downturn and an increase in Medicaid coverage.

The 21-gene recurrence score (RS) assay (Oncotype DX™) predicts the likelihood of breast cancer recurrence and chemotherapy responsiveness. The aims of this study were to describe temporal trends in assay usage, to investigate factors associated with the receipt of the assay and to determine how the assay is associated with treatment decisions. Random samples of stage I-II female breast cancer patients diagnosed in 2004, 2005 and 2010 as reported to the National Cancer Institute's Surveillance Epidemiology and End Results program were included. Among women diagnosed in 2010 with estrogen receptor positive (ER+), lymph node-negative (LN-) tumors, factors associated with receipt of the assay were identified and the likelihood of chemotherapy by RS was estimated. Assay usage increased over time (ER+/LN-:8.0-27.0 %, p0.01; ER+/LN+: 2.0-15.7 %, p = 0.09; ER-: 0.2-1.7 %, p0.01) from 2005 to 2010. Receipt of the assay was associated with younger age, lower area income and tumor characteristics. Among women in the low (RS18) and high risk (RS30) categories, 3.3 and 95.9 % received chemotherapy, respectively. Within the intermediate risk group the receipt of chemotherapy varied: 12.8 % (RS: 18-19), 35.0 % (RS: 20-23) and 84.0 % (RS: 24-30). During the study years, assay usage increased among women for whom the assay is and is not guideline recommended. Factors such as insurance and race/ethnicity do not appear to be associated with the receipt of the assay. The RS, as determined broadly via three categories and within the intermediate risk group, does appear to influence chemotherapy decisions.

PurposeDespite recommendations for breast cancer survivorship care, African American women are less likely to receive appropriate follow-up care, which is concerning due to their higher mortality rates. This study describes differences in barriers to follow-up care between African American and White breast cancer survivors.MethodsWe conducted a mailed survey of women treated for non-metastatic breast cancer in 2009-2011, 6-24 months post-treatment (N = 203). Survivors were asked about 14 potential barriers to follow-up care. We used logistic regression to explore associations between barriers and race, adjusting for covariates.ResultsOur participants included 31 African American and 160 White survivors. At least one barrier to follow-up care was reported by 62 %. Compared to White survivors, African Americans were more likely to identify barriers related to out-of-pocket costs (28 vs. 51.6 %, p = 0.01), other health care costs (21.3 vs. 45.2 %, p = 0.01), anxiety/worry (29.4 vs. 51.6 %, p = 0.02), and transportation (4.4 vs. 16.1 %, p = 0.03). After adjustment for covariates, African Americans were three times as likely to report at least one barrier to care (odds ratio (OR) = 3.3, 95 % confidence interval (CI) = 1.1-10.1).ConclusionsBarriers to care are common among breast cancer survivors, especially African American women. Financial barriers to care may prevent minority and underserved survivors from accessing follow-up care. Enhancing insurance coverage or addressing out-of-pocket costs may help address financial barriers to follow-up care among breast cancer survivors. Psychosocial care aimed at reducing fear of recurrence may also be important to improve access among African American breast cancer survivors.

Healthy People 2020 (HP2020) includes objectives to increase screening for breast, cervical, and colorectal cancer (1) as recommended by the U.S. Preventive Services Task Force (USPSTF).* Progress toward meeting these objectives is monitored by measuring cancer screening test use against national targets using data from the National Health Interview Survey (NHIS) (1). Analysis of 2015 NHIS data indicated that screening test use remains substantially below HP2020 targets for selected cancer screening tests. Although colorectal cancer screening test use increased from 2000 to 2015, no improvements in test use were observed for breast and cervical cancer screening. Disparities exist in screening test use by race/ethnicity, socioeconomic status, and health care access indicators. Increased measures to implement evidence-based interventions and conduct targeted outreach are needed if the HP2020 targets for cancer screening are to be achieved and the disparities in screening test use are to be reduced.

2551 Background: NCORP is a model program that bridges academic and community oncology practices and research. Over the past decade, community cancer investigators have adopted new technology, encountered new treatment sequalae, and faced rising cost of care with its financial toxicity imposed upon individuals seeking care. Opportunities are abundant for community investigators to assess feasibility and uptake of research advances into community practice settings, yet these opportunities are met with the challenges of dynamic changes in types of organizations delivering cancer care and diversity of populations within their catchment areas. Little information is shared about how and to what extent the health environment influences this partnership and the implementation of a broad cancer research portfolio. Methods: This abstract reports on the continued interest and participation of community oncologists in research which is demonstrated by 987 practices with over 4000 investigators in NCORP. Since 2014, over 30,000 individuals enrolled in symptom management, screening, surveillance, quality of life, and treatment trials. An additional 4500 patients and clinicians have enrolled in care delivery studies. Results: NCORP has been central in evaluating the most effective strategies for investigators to effectively communicate to patients the science of genomically-driven trials. It has also provided ways of bringing the pediatric and AYA patients access to the most up-to-date treatment strategies and new therapies in their community. This creates the least disruption on family structure/dynamics, diminished traveling requirements/costs, and reduced the financial burden. NCORP promotes involvement of treating oncologists in research activities. This also improves care for patients not enrolled in clinical trials. Therefore, NCORP serves as a laboratory to determine the most effective strategies for co-management of cancer patients and survivors. Conclusions: Several questions however remain to be addressed using this clinical trial model. These include: how to continue to reduce disparities in cancer care and clinical trial participation; and, what are the best strategies for fostering implementation of cancer care models in community practice.

Little is known about the cognitive factors associated with adherence to antiestrogen therapy. Our objective was to investigate the association between domain-specific cognitive function and adherence among women in a clinical prevention trial of oral antiestrogen therapies. We performed a secondary analysis of Co-STAR, an ancillary study of the STAR breast cancer prevention trial in which postmenopausal women at increased breast cancer risk were randomized to tamoxifen or raloxifene. Co-STAR enrolled nondemented participants ≥65 years old to compare treatment effects on cognition. The cognitive battery assessed global cognitive function (Modified Mini-Mental State Exam), and specific cognitive domains of verbal knowledge, verbal fluency, figural memory, verbal memory, attention and working memory, spatial ability, and fine motor speed. Adherence was defined by a ratio of actual time taking therapy per protocol ≥80% of expected time. Logistic regression was used to evaluate the association between cognitive test scores and adherence to therapy. The mean age of the 1,331 Co-STAR participants was 67.2 ± 4.3 years. Mean 3MS score was 95.1 (4.7) and 14% were nonadherent. In adjusted analyses, the odds of nonadherence were lower for those with better scores on verbal memory [OR (95% confidence interval): 0.75 (0.62–0.92)]. Larger relative deficits in verbal memory compared with verbal fluency were also associated with nonadherence [1.28 (1.08–1.51)]. Among nondemented older women, subtle differences in memory performance were associated with medication adherence. Differential performance across cognitive domains may help identify persons at greater risk for poor adherence. Cancer Prev Res; 7(1); 161–8. ©2013 AACR.

Background: Routine follow-up care is recommended to promote the well-being of cancer survivors, but financial difficulties may interfere. Rural–urban disparities in forgoing healthcare due to cost have been observed in the general population; however, it is unknown whether this disparity persists among survivors. The purpose of this study was to examine rural–urban disparities in forgoing healthcare after cancer due to cost. Methods: We analyzed data from 7,804 cancer survivors in the 2006 to 2010 National Health Interview Survey. Logistic regression models, adjusting for sociodemographic and clinical characteristics, were used to assess rural–urban disparities in forgoing medical care, prescription medications, and dental care due to cost, stratified by age (younger: 18–64, older: 65+). Results: Compared with urban survivors, younger rural survivors were more likely to forgo medical care (P < 0.001) and prescription medications (P < 0.001) due to cost; older rural survivors were more likely to forgo medical (P < 0.001) and dental care (P = 0.05). Rural–urban disparities did not persist among younger survivors in adjusted analyses; however, older rural survivors remained more likely to forgo medical [OR = 1.66, 95% confidence interval (CI) = 1.11–2.48] and dental care (OR = 1.54, 95%CI = 1.08–2.20). Conclusions: Adjustment for health insurance and other sociodemographic characteristics attenuates rural–urban disparities in forgoing healthcare among younger survivors, but not older survivors. Financial factors relating to healthcare use among rural survivors should be a topic of continued investigation. Impact: Addressing out-of-pocket costs may be an important step in reducing rural–urban disparities in healthcare, especially for older survivors. It will be important to monitor how healthcare reform efforts impact disparities observed in this vulnerable population. Cancer Epidemiol Biomarkers Prev; 22(10); 1668–76. ©2013 AACR.

Objectives. We examined racial/ethnic disparities in health care receipt among a nationally representative sample of male cancer survivors. Methods. We identified men aged 18 years and older from the 2006–2010 National Health Interview Survey who reported a history of cancer. We assessed health care receipt in 4 self-reported measures: primary care visit, specialist visit, flu vaccination, and pneumococcal vaccination. We used hierarchical logistic regression modeling, stratified by age ( Results. In adjusted models, older African American and Hispanic survivors were approximately twice as likely as were non-Hispanic Whites to not see a specialist (odds ratio [OR] = 1.78; 95% confidence interval [CI] = 1.19, 2.68 and OR = 2.09; 95% CI = 1.18, 3.70, respectively), not receive the flu vaccine (OR = 2.21; 95% CI = 1.45, 3.37 and OR = 2.20; 95% CI = 1.21, 4.01, respectively), and not receive the pneumococcal vaccine (OR = 2.24; 95% CI = 1.54, 3.24 and OR = 3.10; 95% CI = 1.75, 5.51, respectively). Conclusions. Racial/ethnic disparities in health care receipt are evident among older, but not younger, cancer survivors, despite access to Medicare. These survivors may be less likely to see specialists, including oncologists, and receive basic preventive care.

PurposeRural US adults have increased risk of poor outcomes after cancer, including increased cancer mortality. Rural-urban differences in health behaviors have been identified in the general population and may contribute to cancer health disparities, but have not yet been examined among US survivors. We examined rural-urban differences in health behaviors among cancer survivors and associations with self-reported health and health-related unemployment.MethodsWe identified rural (n=1,642) and urban (n=6,162) survivors from the cross-sectional National Health Interview Survey (2006-2010) and calculated the prevalence of smoking, physical activity, overweight/obesity, and alcohol consumption. Multivariable models were used to examine the associations of fair/poor health and health-related unemployment with health behaviors and rural-urban residence.ResultsThe prevalence of fair/poor health (rural 36.7%, urban 26.6%), health-related unemployment (rural 18.5%, urban 10.6%), smoking (rural 25.3%, urban 15.8%), and physical inactivity (rural 50.7%, urban 38.7%) was significantly higher in rural survivors (all p&nbsp

Objectives: To examine the effect of breast cancer and its treatment on fracture risk in older breast cancer survivors. Design: A 10-year prospective cohort study beginning 5 years after a diagnosis of breast cancer for survivors and match date for comparison women. Setting: Six integrated healthcare systems. Participants: Women aged 65 and older (1,286 survivors, 1,286 comparison women, mean age 77.7 in both groups, white, non-Hispanic: survivors, 81.6%; comparison women, 85.2%) who were alive and recurrence free 5 years after a diagnosis of early-stage breast cancer and matched on age, study site, and enrollment year to a comparison cohort without breast cancer. Measurements: Cox proportional hazards models were used to estimate the association between fracture risk and survivor-comparison status, adjusting for drugs and risk factors associated with bone health. A subanalysis was used to evaluate the association between tamoxifen exposure and fracture risk. Results: No difference was observed in fracture rates between groups (hazard ratio (HR) = 1.1, 95% confidence interval (CI) = 0.9�1.3). The protective effect of tamoxifen was not statistically significant (HR = 0.9, 95% CI = 0.6�1.2). Conclusion: Long-term survivors of early-stage breast cancer diagnosed at age 65 and older are not at greater risk of osteoporotic fractures than age-matched women without breast cancer. There appears to be no long-term protection from fractures with tamoxifen use.

An overview of proceedings, findings, and recommendations from the workshop on "Advancing Symptom Science Through Symptom Cluster Research" sponsored by the National Institute of Nursing Research (NINR) and the Office of Rare Diseases Research, National Center for Advancing Translational Sciences, is presented. This workshop engaged an expert panel in an evidenced-based discussion regarding the state of the science of symptom clusters in chronic conditions including cancer and other rare diseases. An interdisciplinary working group from the extramural research community representing nursing, medicine, oncology, psychology, and bioinformatics was convened at the National Institutes of Health. Based on expertise, members were divided into teams to address key areas: defining characteristics of symptom clusters, priority symptom clusters and underlying mechanisms, measurement issues, targeted interventions, and new analytic strategies. For each area, the evidence was synthesized, limitations and gaps identified, and recommendations for future research delineated. The majority of findings in each area were from studies of oncology patients. However, increasing evidence suggests that symptom clusters occur in patients with other chronic conditions (eg, pulmonary, cardiac, and end-stage renal disease). Nonetheless, symptom cluster research is extremely limited and scientists are just beginning to understand how to investigate symptom clusters by developing frameworks and new methods and approaches. With a focus on personalized care, an understanding of individual susceptibility to symptoms and whether a "driving" symptom exists that triggers other symptoms in the cluster is needed. Also, research aimed at identifying the mechanisms that underlie symptom clusters is essential to developing targeted interventions.

Rural residents have higher cancer mortality than urban residents, with the largest disparities observed for lung, colorectal, prostate, and cervical cancers1. Disparities associated with rural residence have also been documented in cancer diagnosis and treatment2–5, but little is known about disparities that may persist into the post-treatment survivorship period. A majority of survivors are now expected to live at least five years after their cancer diagnosis6, increasing the importance of monitoring long-term health and well-being years after treatment is completed. Although estimates of the number of rural cancer survivors have not been published, 21% of the general population resides in rural areas7, defined by the United States (US) Census as residence outside of areas with an urban core of at least 50,000 persons and densely settled contiguous areas8. Rural residents may face challenges in accessing medical care and necessary support services due to extended and sometimes difficult travel and a limited number of health care facilities9, 10. Further, rural residents in general tend to be older, poorer, less educated, less likely to have insurance, and more likely to encounter transportation challenges11–13, exacerbating health disparities. The few studies that have examined quality of life, symptoms, or mental health among rural survivors9, 14, 15 are limited by patient samples recruited from a single state or region. Thus we know little about the population characteristics and health status of rural cancer survivors in the US. The lack of information about rural cancer survivors hampers public health planning, allocation of medical resources, and the development of interventions to target this potentially vulnerable population of survivors. To address these limitations, the goal of this study was to estimate the number of adult cancer survivors who reside in rural areas of the United States and to describe their self-reported health status relative to urban survivors. Compared to non-rural survivors, we expected that rural survivors would report more medical comorbidities and greater psychological distress and would be more likely to report being in fair/poor health and being unable to work because of a health condition.

Acute myelogenous leukemia (AML) is largely a disease of older adults and has disproportionately worse survival with older age; optimal therapy for older adults is unclear.1–4 The disease presents acutely and aggressively, requiring intense chemotherapy for cure. Initial (induction) chemotherapy is given in the hospital and is associated with long hospitalization while awaiting marrow recovery. Although selected older adults can benefit from standard induction chemotherapy, as a group, older adults experience greater treatment-related toxicity and poorer overall survival than younger individuals.1,2,5–7 Research efforts to define optimal therapy have focused on age-related changes in tumor biology and their effect on prognosis.8–13 Less attention has been focused on host-specific clinical characteristics such as cognitive, emotional, and physical function that might predict vulnerability to toxicity14,15 and for which chronologic age alone is an inadequate measure. A limited ability to identify who can tolerate and potentially benefit from standard curative induction chemotherapy hampers treatment decision-making for older adults with AML. Practical clinical assessment tools that reflect an individual's pathologic burden of disease and age-related physiologic changes could add important prognostic information by improving toxicity prediction and informing interventions to improve treatment tolerance. Presently, oncologists estimate functional status using the Karnofsky Scale or the Eastern Cooperative Oncology Group (ECOG) performance status scale (Appendix 1).16 These scales lack sensitivity, are subjective, and do not address specific tasks. Many older adults with “good” performance scores have meaningful impairments in physical function that may reduce reserve capacity.17 Translating geriatric assessment (GA) strategies into the evaluation of older adults with AML could help improve assessment of reserve capacity and inform treatment decision-making. Specifically, a GA including evaluation of cognitive function, psychological state, physical function, and comorbid disease could identify individuals most vulnerable to the side effects of AML chemotherapy.18 In older adults, GA can identify problems that may interfere with cancer treatment in other tumor types.17,19,20 The National Comprehensive Cancer Network guidelines for Senior Adult Oncology recommend this type of assessment, but it has not been extensively validated in individual cancer types,21 nor is it routine in clinical practice. There are no published studies evaluating the feasibility or utility of performing a comprehensive GA in newly diagnosed older adults with AML. GA could be more difficult to implement in such individuals, because they often present acutely, with high symptom burden and multiple competing medical problems. Individuals are frequently assessed and treated in the hospital, rather than in the clinic, and often have conditions requiring rapid attention. To address these issues, the current study set out to determine whether bedside GA is feasible in older adults hospitalized with newly diagnosed AML, describe the performance of older adults with newly diagnosed AML on multiple GA assessment domains, and determine whether these measures add information to assessments of functional status (ECOG score) and tumor biology (cytogenetic risk group classification). Ultimately, information gained from GA could help optimize therapeutic decision-making and clinical outcomes for older adults with AML.

BACKGROUND: Many elderly patients with cancer experience increased cancer-related morbidity and mortality compared with younger patients. In soft tissue sarcoma, adjuvant radiotherapy is an integral part of definitive therapy for limb preservation. The authors of this report hypothesized that age-related disparities exist in the use of radiation. METHODS: Surveillance, Epidemiology, and End Results (SEER) data were used to conduct a retrospective cohort study among patients aged ≥25 years who were diagnosed from 1998 to 2004 with nonmetastatic, biopsy-proven, high-grade soft tissue sarcoma of the extremities and underwent a limb-sparing procedure. Patients were stratified according to age (ages 70 years). Logistic regression was used to determine the association between age and the receipt of radiotherapy adjusting for histology, tumor location, tumor size, surgery, sex, race, and marital status. A Cox proportional hazards model was used to compare disease-specific and all-cause mortality. RESULTS: Among 1354 eligible patients; 37.1% were aged >70 years, 44.3% were women, and 84.4% were Caucasian. Although 73.8% of the cohort received radiotherapy, receipt decreased from 78.2% among patients aged 70 years (test for trend; P = .006). After adjusting for demographic and tumor factors, older patients remained less likely to receive radiotherapy (odds ratio, 0.66; 95% confidence interval, 0.47-0.92) and more likely to experience disease-specific death (hazard ratio, 2.4; 95% confidence interval, 1.4-4.1) compared with the youngest group. CONCLUSIONS: Older adults appeared to be less likely to receive definitive therapy for soft tissue sarcoma of the extremities. In the absence of clinical trials and treatment guidelines tailored to this population, under treatment may disadvantage elderly patients, who have increased cancer-related morbidity and mortality. Cancer 2011;. © 2011 American Cancer Society.

49 Background: One decade after the Institute of Medicine report recommended the development of quality of cancer survivorship care measures, there remains little progress in achieving that goal. Our goal was to develop a framework for quality measurement and outline the next steps needed to drive research, policy and clinical care. Methods: We conducted a scoping review to identify quality domains and indicators for cancer survivorship care that included: (1) published cancer/cancer survivorship guidelines; (2) National Cancer Institute and Patient-Centered Outcomes Research Institute-funded cancer survivorship studies; (3) U.S. state Comprehensive Cancer Control Plans; (4) indicators developed by national quality organizations. We also reviewed published literature, specifically focusing on narrative and systematic reviews, commentaries/editorials and position papers addressing cancer survivorship care quality. We then conducted interviews with key experts in cancer survivorship and quality. Once the framework was developed, we convened a stakeholder meeting to outline actionable next steps. Results: Key domains focused on (1) cancer and its treatment, specifically prevention and surveillance of recurrences and second cancers as well as surveillance and management of physical and psychosocial effects and (2) primary health care needs such as management of multiple medical conditions and health promotion. Patient experience, communication, care coordination and health care delivery structure are critical domains in cancer survivorship care that must be measured. Lastly, domains included health care outcomes, such as utilization, costs, mortality and quality of life. Respective indicators and findings from stakeholder meeting will be presented at the Symposium. Conclusions: We developed a framework that will promote a systematic approach to (1) designing effective, evidence-based clinical care for cancer survivors in oncology and primary care settings, (2) expanding research initiatives to address identified gaps in quality measurement and (3) developing policy recommendations to encourage the implementation of standardized measures for quality improvement.

Approximately 60% of cancers are diagnosed in persons aged 65 and older.1 In general, older adults with cancer have lower survival and higher morbidity with treatment than younger people.2 Some older cancer patients can benefit from intensive therapies,3,4 but there is limited information regarding the clinical characteristics that influence outcomes. Although clinical outcomes vary based on tumor type and treatment, patient-specific characteristics are also important predictors of survival and tolerance of therapy.5–8 Identifying specific measurable characteristics to better predict acute treatment-related toxicity, future disability, and survival is critical to inform decision-making for older cancer patients.9,10 Physical function is a key element in the evaluation of frailty in geriatric populations and may help predict clinical outcomes in older patients with cancer.11 In oncology practice, physical function is typically estimated using the Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance scales.12 These scales lack sensitivity, are subjective, and do not address specific physical tasks. Many older adults with “good” performance scores have meaningful impairments in physical function that may reduce reserve capacity.13 Whereas these scales are predictive of outcomes in older adults with substantial functional impairment at diagnosis,14,15 they are less useful for most older patients with cancer, who do not have substantial disability at the time of cancer diagnoses.8,13 Thus, more-sensitive, -objective, and -task-focused measures of physical function are needed for this population. Physical performance measures (e.g., walking speed and grip strength) predict future disability, hospitalizations, and mortality in the general geriatric population.16–19 Assessment of physical performance to evaluate frailty is currently included in the National Comprehensive Cancer Network Guidelines for Senior Adult Oncology,20 but the predictive value of these tests in older patients with cancer has not been evaluated. In the present analysis, it was hypothesized that measures of physical performance (usual walking speed over 20 m, 400-m long-distance corridor walk (LDCW), and grip strength) obtained close to the time of cancer diagnosis in older adults with malignancy would predict overall survival and short-term outcome (2-year progression to disability or death).

Because of recent studies showing strong prevention benefit and acceptable psychosocial outcomes, more women may be considering prophylactic mastectomy. A growing literature shows some positive psychosocial outcomes for women with bilateral prophylactic mastectomy, but less is known about women with contralateral prophylactic mastectomy. Several surveys have shown that a large majority of women with prophylactic mastectomy report satisfaction with their decisions to have the procedure when asked in a quantitative, closed-ended format. We sought to explore the nuances of women's satisfaction with the procedure using a qualitative, open-ended format. We included open-ended questions as part of a mailed survey on psychosocial outcomes of prophylactic mastectomy. The research team coded and analyzed these responses using qualitative methods. We used simple descriptive statistics to compare the demographics of the entire survey sample to those women who answered the open-ended questions; the responses to the open- and closed-ended satisfaction questions, and the responses of women with bilateral and contralateral prophylactic mastectomy. Seventy-one percent of women with prophylactic mastectomy responded to the survey and 48% provided open-ended responses about psychosocial outcomes. Women's open-ended responses regarding psychosocial outcomes could be coded into one of three general categories--positive, negative, and disparate. In the subgroup of women with both open- and closed-ended responses, over 70% of women providing negative and disparate comments to the open-ended question simultaneously indicated satisfaction on a closed-ended question. Negative and disparate open-ended responses were twice as common among women with bilateral prophylactic mastectomy (52%) than women with contralateral prophylactic mastectomy (26%). These findings suggest that even among women who report general satisfaction with their decision to have prophylactic mastectomy via closed-ended survey questions, lingering negative psychosocial outcomes can remain, particularly among women with bilateral prophylactic mastectomy. This dichotomy could be an important factor to discuss in counseling women considering the procedure.

Purpose There are more than 2,000,000 breast cancer survivors in the United States today. While surveillance for asymptomatic recurrence and second primary is included in consensus recommendations, the effectiveness of this surveillance has not been well characterized. Our purpose is to estimate the effectiveness of surveillance mammography in a cohort of breast cancer survivors with complete ascertainment of surveillance mammograms and negligible losses to follow-up. Patients and Methods We enrolled 1,846 stage I and II breast cancer patients who were at least 65 years old at six integrated health care delivery systems. We used medical record review and existing databases to ascertain patient, tumor, and therapy characteristics, as well as receipt of surveillance mammograms. We linked personal identifiers to the National Death Index to ascertain date and cause of death. We matched four controls to each breast cancer decedent to estimate the association between receipt of surveillance mammogram and breast cancer mortality. Results One hundred seventy-eight women died of breast cancer during 5 years of follow-up. Each additional surveillance mammogram was associated with a 0.69-fold decrease in the odds of breast cancer mortality (95% CI, 0.52 to 0.92). The protective association was strongest among women with stage I disease, those who received mastectomy, and those in the oldest age group. Conclusion Given existing recommendations for post-therapy surveillance, trials to compare surveillance with no surveillance are unlikely. This large observational study provides support for the recommendations, suggesting that receipt of surveillance mammograms reduces the rate of breast cancer mortality in older patients diagnosed with early-stage disease.

The quality of medical record abstracts is often characterized in a reliability substudy. These results usually indicate agreement, but not the extent to which lack of agreement affects associations observed in the complete data. In this study, medical records were reviewed and abstracted for patients diagnosed with stage I or stage II breast cancer between 1990 and 1994 at one of six US Cancer Research Network sites. For a subsample, interrater reliability data were available. The authors calculated conventional hazard ratios and 95% confidence intervals for the association of demographic, tumor, and treatment characteristics with recurrence rate. These conventional estimates of effect were compared with three sets of estimates and 95% simulation intervals that took account of the uncertainty assessed by lack of agreement in the reliability substudy. The rate of recurrence was associated with increasing cancer stage and with treatment modality but not with demographic characteristics. The hazard ratios and simulation intervals that took account of the reliability data showed that the simulation interval grew wider as the sources of uncertainty taken into account grew more complete, but the associations expected a priori remained readily apparent. While many investigators use reliability data only as a metric for data quality, a more thorough approach can also quantitatively depict the uncertainty in the observed associations.

BACKGROUND. This study was designed to investigate whether the mortality from heart disease, a manifestation of intercurrent disease after postoperative radiotherapy (PORT), has decreased over time for patients with nonsmall cell lung cancer (NSCLC). METHODS. The 17-registry 1973 to 2003 dataset from the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) Program was used to create a cohort of patients with NSCLC who had evidence of ipsilateral lymph node involvement diagnosed from 1983 to 1993 and who underwent pnuemonectomy/lobectomy (n = 6148 patients). Heart disease mortality was the primary endpoint: Deaths from other causes were censored, and surviving patients were censored at 10 years. The independent variable was PORT use, and adjustment variables included age at diagnosis, sex, race, year of diagnosis, laterality, location, histology, and the operation performed. RESULTS. Multivariate analysis revealed that PORT use was associated with an increase in heart disease mortality (hazards ratio [HR], 1.30; 95% confidence interval [95% CI], 1.04–1.61; P = .0193) along with older age, male sex, African-American race, and earlier year of diagnosis. The association was confirmed in the cohort that was diagnosed from 1983 to 1988 (HR, 1.49; 95% CI, 1.11–2.01 [P = .0090]) but not for the cohort that was diagnosed from 1989 to 1993 (HR, 1.08; 95% CI, 0.79–1.48 [P = .6394]). CONCLUSIONS. The results from this study demonstrated that the risk of heart disease mortality associated with PORT has declined in more recent years. This may be secondary to improvements in the treatment planning and delivery of thoracic radiotherapy. Properly designed, prospective, adjuvant trials will be needed to verify these findings. Cancer 2007; 110:911–7. © 2007 American Cancer Society.

Each year, 70,000 adolescents and young adults (AYAs) between ages 15 and 39 years in the United States are diagnosed with cancer. In 2006, a National Cancer Institute (NCI) Progress Review Group (PRG) examined the state of science associated with cancer among AYAs. To assess the impact of the PRG and examine the current state of AYA oncology research, the NCI, with support from the LIVESTRONG Foundation, sponsored a workshop entitled “Next Steps in Adolescent and Young Adult Oncology” on September 16 and 17, 2013, in Bethesda, Maryland. This report summarizes the findings from the workshop, opportunities to leverage existing data, and suggestions for future research priorities. Multidisciplinary teams that include basic scientists, epidemiologists, trialists, biostatisticians, clinicians, behavioral scientists, and health services researchers will be essential for future advances for AYAs with cancer.

With prior reports indicating a lack of progress in survival improvement in older adolescents and young adults (AYAs) aged 15 to 39 years with cancer compared with both younger and older patients with cancer, the current analysis provides an update of survival trends of cancers among AYAs, children, and older adults.Data from the National Cancer Institute Surveillance, Epidemiology, and End Results database for 13 regions were used to ascertain survival trends of the 34 most frequent cancers diagnosed in AYAs compared with children and older adults.As of 2002 through 2006, the 5-year relative survival rate for all invasive cancers in AYAs was 82.5% (standard error, 0.2%). In AYAs, 14 cancers demonstrated evidence of a statistically significant improvement in their 5-year relative survival since 1992. Survival improved less in AYAs than in children for acute myeloid leukemia and medulloblastoma. Fourteen cancers had survival improvements that were found to be less in AYAs compared with older adults, including hepatic carcinoma, acute myeloid leukemia, high-grade astrocytoma, acute lymphocytic leukemia, pancreatic carcinoma, low-grade astrocytoma, gastric carcinoma, renal carcinoma, cancer of the oral cavity and pharynx, Hodgkin lymphoma, ovarian cancer, fibromatous sarcoma, other soft tissue sarcoma, and thyroid carcinoma.Improvements in the survival of several cancer types that occur frequently in AYAs are encouraging. However, survival does not appear to be improving to the same extent in AYAs as in children or older adults for several cancers. Further investment in exploring the distinct biology of tumors in this age group, and of their hosts, must be a priority in AYA oncology.

Purpose A substantial literature describes age-dependent variations in breast cancer treatment, showing that older women are less likely to receive standard treatment than younger women. We sought to identify patient and tumor characteristics associated with the nonreceipt of standard primary tumor and systemic adjuvant therapies. Patients and Methods We studied 1,859 women age 65 years or older with stage I and II breast cancer diagnosed between 1990 and 1994 who were cared for in six geographically dispersed community-based health care systems. We collected demographic, tumor, treatment, and comorbidity data from electronic data sources, including cancer registry, administrative, and clinical databases, and from subjects' medical records. Results Women 75 years of age or older and women with higher comorbidity indices were more likely to receive nonstandard primary tumor therapy, to not receive axillary lymph node dissection, and to not receive radiation therapy after breast-conserving surgery (BCS). Asian women were less likely to receive BCS, and African American women were less likely to be prescribed tamoxifen. Although nonreceipt of most therapies was associated with a lower baseline risk of recurrence, an important minority of high-risk women (16% to 30%) did not receive guideline therapies. Conclusion Age is an independent risk factor for nonreceipt of effective cancer therapies, even when comorbidity and risk of recurrence are taken into account. Information regarding treatment effectiveness in this age group and tools that allow physicians and patients to estimate the benefits versus the risks of therapies, taking into account age and comorbidity burden, are critically needed.

Background and Objectives To characterize the impact of multiple Institutional Review Board (IRB) reviews on multicenter observational research studies, and identify strategies for overcoming the identified challenges. Materials and Methods Using PubMed, we identified empirical studies, anecdotal reports, and opinion pieces addressing the process of obtaining initial IRB approval for multicenter clinical trials and observational studies. We also reviewed relevant information from federal and other national sources. Results A total of 40 peer-reviewed articles were synthesized, plus six reports from commissions or other key sources. These sources identified numerous challenges that researchers may encounter when multicenter studies undergo review by multiple IRBs, such as added time for initial review and approval and different requirements across IRBs. Strategies to alleviate these challenges include planning to accommodate multiple reviews and determining upfront whether certain variations to study protocols are tolerable across sites. Many researchers and commissions have proposed comprehensive reforms, such as centralized review for multicenter projects. Conclusion Policy-makers, researchers, and IRBs should convene to specifically discuss optimal approaches for multicenter review. However, until structural changes are implemented, observational researchers should develop and implement strategic plans for obtaining IRB approval in multicenter studies, including adopting models successfully employed by clinical trials.

Objective This study assesses the variability in requirements among six institutional review boards (IRBs) and the resulting protocol variations for a multicenter mailed survey. Study Design and Setting We utilized a cross-sectional mailed survey to gather information on long-term psychosocial outcomes of prophylactic mastectomy among women at six health maintenance organizations, all of which are part of the Cancer Research Network. In the context of this collaborative study, we characterized the impact of the different sites' IRB review processes on the study protocol and participation. Results IRB review resulted in site differences in physician consent prior to participant contact, invitation letter content and signatories, and incentive type. The review process required two to eight modifications beyond the initial application and resulted in unanticipated delays and costs. Conclusion Site-to-site variability in IRB requirements may adversely impact scientific rigor and delay implementation of collaborative studies, especially when not considered in project planning. IRB review is an essential aspect of research but one that can present substantial challenges for multicenter studies.