An orientation to the US National Cancer plan for the research community.

The US National Cancer Act of 1971 designated the director of the National Cancer Institute as responsible for coordinating federal agencies and nonfederal organizations to make progress against cancer. As part of her role, the immediate past director of the National Cancer Institute (MMB) led the development of a National Cancer Plan that was formally released on April 3, 2023. The plan includes 8 aspirational goals "to achieve a society where every person with cancer lives a full and active life and to prevent most cancers so that few people need to face this diagnosis." Research findings provide a foundation for each goal, and research gaps are included in the strategies for meeting each goal. The President's Cancer Panel, also created by the National Cancer Act, conducted an initial assessment of progress toward the plan goals by hearing from 12 organizations at a virtual public meeting on September 7, 2023. The purpose of this commentary is to orient the scientific community to the plan and call attention to related knowledge gaps that could benefit from research.

Influence of Cost-Related Considerations on Clinical Trial Participation: Results from the 2020 Health Information National Trends Survey (HINTS).

BACKGROUND: People experiencing financial burden are underrepresented in clinical trials. OBJECTIVE: Describe the prevalence of cost-related considerations influential to trial participation and their associations with person-level characteristics. DESIGN: This cross-sectional study used and assessed how three cost-related considerations would influence the decision to participate in a hypothetical clinical trial. PARTICIPANTS: 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. KEY RESULTS: 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.

A History of Health Economics and Healthcare Delivery Research at the National Cancer Institute.

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.

Thematic Analysis of Organizational Characteristics in NCI Community Oncology Research Program Cancer Care Delivery Research.

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.

The National Cancer Institute's Role in Advancing Health-Care Delivery Research.

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.

Opportunities for Cancer Health Care Disparities and Care Delivery Research: An Analysis of the NCI Health Care Delivery Research Program Portfolio.

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.

Delivery of Financial Navigation Services Within National Cancer Institute-Designated Cancer Centers.

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 nonmedical 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 nonmedical 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.

Reimbursement Matters: Overcoming Barriers to Clinical Trial Accrual.

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.

A randomized trial of mail and email recruitment strategies for a physician survey on clinical trial accrual.

BACKGROUND: Patient participation in cancer clinical trials is suboptimal. A challenge to capturing physicians' insights about trials has been low response to surveys. We conducted a study using varying combinations of mail and email to recruit a nationally representative sample of medical, surgical, and radiation oncologists to complete a survey on trial accrual. METHODS: We randomly assigned eligible physicians identified from the American Medical Association MasterFile (n = 13,251) to mail- or email-based recruitment strategies. Mail-based recruitment included a survey packet with: (1) cover letter describing the survey and inviting participation; (2) paper copy of the survey and postage-paid return envelope; and (3) a web link for completing the survey online. Email-based recruitment included an e-mail describing the survey and inviting participation, along with the web link to the survey, and a reminder postcard 2 weeks later. RESULTS: Response was higher for mail-based (11.8, 95% CI 11.0-12.6%) vs. email-based (4.5, 95% CI 4.0-5.0%) recruitment. In email-based recruitment, only one-quarter of recipients opened the email, and even fewer clicked on the link to complete the survey. Most physicians in mail-based recruitment responded after the first invitation (362 of 770 responders, 47.0%). A higher proportion of responders vs. non-responders were young (ages 25-44 years), men, and radiation or surgical (vs. medical) oncologists. CONCLUSIONS: Most physicians assigned to mail-based recruitment actually completed the survey online via the link provided in the cover letter, and those in email-based recruitment did not respond until they received a reminder postcard by mail. Providing the option to return a paper survey or complete it online may have further increased participation in the mail-based group, and future studies should examine how combinations of delivery mode and return options affect physicians' response to surveys.

Comparison of Physician Data in Two Data Files Available for Cancer Health Services Research.

INTRODUCTION: Physicians are vital to health-care delivery, but assessing their impact on care can be challenging given limited data. Historically, health services researchers have obtained physician characteristics data from the American Medical Association (AMA) Physician Masterfile. The Center for Medicare and Medicaid Services' Medicare Data on Provider Practice and Specialty (MD-PPAS) file was assessed, as an alternative source of physician data, particularly in the context of cancer health services research. METHODS: We used physician National Provider Identifiers in the MD-PPAS data (2008-2014) to identify physicians in the AMA data current as of July 18, 2016. Within each source, we grouped physicians into six broad specialty groups. Percent agreement and Cohen's kappa coefficient (k) were calculated for age, sex, specialty, and practice state. RESULTS: Among the 698 202 included physicians, there was excellent agreement for age (percent agreement = 97.7%, k = 0.97) and sex (99.4%, k = 0.99) and good agreement for specialty (86.1%, k = 0.80). Within specialty, using AMA as the reference, agreement was lowest for oncologists (77%). Approximately 85.9% of physicians reported the same practice state in both data sets. CONCLUSION: Although AMA data have been commonly used to account for physician-level factors in health services research, MD-PPAS data provide researchers with an alternative option depending on study needs. MD-PPAS data may be optimal if nonphysicians, provider utilization, practice characteristics, and/or temporal changes are of interest. In contrast, the AMA data may be optimal if more granular specialty, physician training, and/or a broader inclusion of physicians is of interest.

Survivorship objectives in comprehensive cancer control plans: a systematic review.

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. IMPLICATIONS FOR CANCER SURVIVORS: 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.

Preferences for breast cancer survivorship care by rural/urban residence and age at diagnosis.

PURPOSE: Preferences for survivorship care among recently treated breast cancer survivors may vary by rural-urban residence and age, but potential differences have not been examined. METHODS: We conducted a cross-sectional survey of survivorship preferences among women treated for non-metastatic breast cancer 6-24 months prior to recruitment. RESULTS: We surveyed 203 women (66% response) with American Joint Committee on Cancer Stage I or II breast cancer. Rural residents comprised 36.5% of respondents (82.7% White, non-Hispanic; 52.5% < college education) and 29.6% were ≥ 65 years. More than 95% indicated that checking for recurrence, receiving additional treatment, evaluation of side effects, and identification of late effects were "very important" reasons for follow-up care. The most common topics identified as "very important" for survivorship care discussions were recommendations for healthy behaviors (65.3%), best sources for breast cancer information (65.3%), and effects on family (53.3%) and job (53.8%). Women 65 years and older preferred to discuss follow-up care at the time of diagnosis (p = 0.002), with younger women preferring during (32%) or after treatment (39.1%). Rural survivors were significantly more likely to identify follow-up care reasons not related to the initial breast cancer as "very important" than urban survivors, including screening for other cancers, and examinations or tests for non-cancer diseases (both p = 0.01). CONCLUSIONS: Survivorship care in accordance with national recommendations will likely be accepted by breast cancer survivors. Tailoring breast cancer survivorship care by timing, integration of primary care services, and specific psychosocial topics may best meet the needs of different ages and demographics.

Evolution of Cancer Care Delivery Research in the NCI Community Oncology Research Program.

Research seeking to improve patient engagement with decision-making, use of evidence-based guidelines, and coordination of multi-specialty care has made important contributions to the decades-long effort to improve cancer care. The National Cancer Institute expanded support for these efforts by including cancer care delivery research in the 2014 formation of the National Cancer Institute Community Oncology Research Program (NCORP). Cancer care delivery research is a multi-disciplinary effort to generate evidence-based practice change that improves clinical outcomes and patient well-being. NCORP scientists and community-based clinicians and organizations rapidly embraced the addition of this type of research into the network, resulting in a robust portfolio of observational studies and intervention studies within the first 5 years of funding. This commentary describes the initial considerations in conducting this type of research in a network previously focused on cancer prevention, control, and treatment studies; characterizes the protocols developed to date; and outlines future directions for cancer care delivery research in the second round of NCORP funding.

Care delivery, patient experiences, and health outcomes among sexual and gender minority patients with cancer and survivors: A scoping review.

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.

Addressing Challenges in Converting Grant-Funded Infrastructures to Broadly Used Research Resources.

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.

Developing a Quality of Cancer Survivorship Care Framework: Implications for Clinical Care, Research, and Policy.

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.