Validation of a Population-Based Data Source to Examine National Cancer Clinical Trial Participation.

Importance: The Centers for Medicare & Medicaid Services requires health care organizations to report the National Clinical Trial (NCT) identifier on claims for items and services related to clinical trials that qualify for coverage. This same NCT identifier is used to identify clinical trials in the ClinicalTrials.gov registry. If linked, this information could facilitate population-based analyses of clinical trial participation and outcomes. Objective: To evaluate the validity of a linkage between fee-for-service (FFS) Medicare claims and ClinicalTrials.gov through the NCT identifier for patients with cancer enrolled in clinical trials. Design, Setting, and Participants: This cohort study included 2 complementary retrospective analyses for a validation assessment. First, billing data from 3 health care institutions were used to estimate the missingness of the NCT identifier in claims by calculating the proportion of known participants in cancer clinical trials with no NCT identifier on any submitted Medicare claims. Second, the Surveillance Epidemiology and End Results-Medicare data set, which includes a subset of all FFS Medicare beneficiaries for whom health insurance claims are linked with cancer registry data, was used to identify adult patients diagnosed with cancer between 2006 and 2015 with an NCT identifier in claims corresponding to an interventional cancer clinical trial. To estimate the accuracy of the NCT identifier when present, the proportion of NCT identifiers that corresponded to trials that were aligned with the patients' known primary or secondary diagnoses was calculated. Data were analyzed from March 2020 to March 2021. Exposures: An NCT identifier present in Medicare claims. Main Outcomes and Measures: The main outcome was participating in a clinical trial relevant to patient's cancer diagnosis. Results: A total of 1 171 816 patients were included in analyses. Across the 3 participating institutions, there were 5061 Medicare patients enrolled in a clinical trial, including 3797 patients (75.0%) with an NCT identifier on at least 1 billing claim that matched the clinical trial on which the patient was participating. Among 1 171 816 SEER-Medicare patients, 29 138 patients (2.5%) had at least 1 claim with a value entered in the NCT identifier field corresponding to 32 950 unique patient-NCT identifier pairs. There were 26 694 pairs (81.0%) with an NCT identifier corresponding to a clinical trial registered in ClinicalTrials.gov, of which 10 170 pairs (38.1%) were interventional cancer clinical trials. Among these, 9805 pairs (96.4%) were considered appropriate. Conclusions and Relevance: In this cohort study, this data linkage provided a novel data source to study clinical trial enrollment patterns among Medicare patients with cancer on a population level. The presence of the NCT identifiers in claims for Medicare patients participating in clinical trials is likely to improve over time with increasing adherence with the Centers for Medicare & Medicaid Services mandate.

Serious adverse events in African-American cancer patients with sickle cell trait and inherited haemoglobinopathies in a SEER-Medicare claims cohort.

African-American (AA) cancer patients have long-experienced worse outcomes compared to non-Hispanic whites (NHW). No studies to date have evaluated the prognostic impact of sickle cell trait (SCT) and other inherited haemoglobinopathies, of which several are disproportionately high in the AA population. In a cohort analysis of treated patients diagnosed with breast or prostate cancer in the linked SEER-Medicare database, the relative risk (RR) for ≥1 serious adverse events (AEs), defined as hospitalisations or emergency department visits, was estimated for 371 AA patients with a haemoglobinopathy (AA+) compared to patients without haemoglobinopathies (17,303 AA-; 144,863 NHW-). AA+ patients had significantly increased risk for ≥1 AEs compared to AA- (RR = 1.19; 95% CI 1.11-1.27) and NHW- (RR = 1.23; 95% CI 1.15-1.31) patients. The magnitude of effect was similar by cancer type, and in analyses of AA+ with SCT only. Our findings suggest a novel hypothesis for disparities in cancer outcomes.

Survivorship care plans: is there buy-in from community oncology providers?

BACKGROUND: The Institute of Medicine recommended that survivors of cancer and their primary care providers receive survivorship care plans (SCPs) to summarize cancer treatment and plan ongoing care. However, the use of SCPs remains limited. METHODS: Oncology providers at 14 National Cancer Institute Community Cancer Centers Program hospitals completed a survey regarding their perceptions of SCPs, including barriers to implementation, strategies for implementation, the role of oncology providers, and the importance of topics in SCPs (diagnosis, treatment, recommended ongoing care, and the aspects of ongoing care that the oncology practice will provide). RESULTS: Among 245 providers (response rate of 70%), 52% reported ever providing any component of an SCP to patients. The most widely reported barriers were lack of personnel and time to create SCPs (69% and 64% of respondents, respectively). The most widely endorsed strategy among those using SCPs was the use of a template with prespecified fields; 94% of those who used templates found them helpful. For each topic of an SCP, although 87% to 89% of oncology providers believed it was very important for primary care providers to receive the information, only 58% to 65% of respondents believed it was very important for patients to receive the information. Furthermore, 33% to 38% of respondents reported mixed feelings regarding whether it was the responsibility of oncology providers to provide SCPs. CONCLUSIONS: Practices need additional resources to overcome barriers to implementing SCPs. We found resistance toward SCPs, particularly the perceived value for the survivor and the idea that oncology providers are responsible for SCP dissemination.

Exploring implications of Medicaid participation and wait times for colorectal screening on early detection efforts in Connecticut--a secret-shopper survey.

BACKGROUND: Routine colorectal screening, decreases in incidence, and advances in treatment have lowered colorectal cancer mortality rates over the past three decades. Nevertheless, it remains the second most common cause of cancer death amongst men and women combined in U.S. Most cases of colon cancer are diagnosed at a late stage leading to poor survival outcomes for patients. After extensive research of publically available data, it would appear that the state of Connecticut does not have available state-wide data on patient wait times for routine colonoscopy screening. Furthermore, there are no publicly available, or Connecticut-specific, reports on Medicaid participation rates for colorectal screening amongst gastroenterologists (GI) in Connecticut. In 2012, the American Cancer Society report on Colorectal Cancer Screening Rates confirmed barriers to health-care access and disparities in health outcomes and survival rates for colon cancer patients based on race, ethnicity, and low socioeconomic status. Given this information, one could conjecture that low Medicaid participation rates among GIs could potentially have a more severe impact on health-care access and outcomes for underserved populations. At present, funding and human resources are being employed across the state of Connecticut to address bottlenecks in colorectal cancer screening. More specifically, patient navigation and outreach programs are emerging and expanding to address the gaps in services for hard-to-reach populations and the medically underserved. Low Medicaid participation rates and increased wait times for colonoscopy screening may impair the efficacy of colorectal cancer patient navigation and outreach efforts and potentially funding for future interventions. In this study, we report the results of our secret-shopper telephone survey comprising of 93 group and independent gastroenterologist (GI) practices in different counties of Connecticut. METHODS: Reviewing online resources and yellow pages, researchers compiled a county-specific list of GI practices throughout Connecticut and conducted a secret-shopper survey by telephone. A standard script and set of questions was formulated and used for each telephone call to GI practices. Data was analyzed in context of statistics available to the public at large from the U.S. Census Bureau. RESULTS: Overall, 46% of all 93 practices and 62% of individual GIs from all 93 practices state-wide reported Medicaid participation. About 35% of surveyed practices were independent practices; 41% of these reported Medicaid participation. About 65% of surveyed practices were group practices; 49% of these reported Medicaid participation. Approximately, 85% of all practices are in Fairfield, Hartford, orNew Haven counties. Of all three counties, New Haven reported the highest Medicaid participation rate by practices; 62% of all practices in New Haven reported participation. Fairfield reported the lowest Medicaid participation rate by practices; 29% of all practices in Fairfield reported participation. When Medicaid participation rates were calculated for total number of gastroenterologists from all practices in a given county (as opposed to participation rates by number of practices), Medicaid participation rates were 80% and 44% for New Haven and Fairfield, respectively. Of all practices in Hartford, only 50% reported Medicaid participation, whereas 67% of the total number of gastroenterologists (as opposed to practices) reported Medicaid participation. According to a recent national survey, 47% of gastroenterologists reported stopping accepting new Medicaid patients. Overall minimum and maximum wait times were reported to be the highest for Hartford, but wait times were long even for smaller counties, reflecting a possible imbalance in supply and demand or inefficiency in allocating the available resources. CONCLUSIONS: Only a limited number of gastroenterology practices in Connecticut accept Medicaid patients, notably in selected counties, but in all counties, and this may add to access barriers. It is yet unclear whether these disparities are significant enough to create a supply-demand imbalance and thus, have a significantly negative impact on health outcomes for the underserved. Nevertheless, with the high unemployment rates and impending implementation of mandated state-wide health-care reform as outlined in the Affordable Care Act, the Medicaid population in the state of Connecticut will increase, increasing future demand for services. In addition, based on the survey findings, longer wait times for colonoscopy screening are reported for the many of GI practices in Connecticut for Medicaid-insured as well as non-Medicaid patients. Longer wait times may have an impact on patient compliance, especially for the underserved populations that are hard to reach and ensure follow-up, contributing to potential delayed diagnosis. A Medicaid-associated disparity in this area will serve to exacerbate the problem for the underserved compared to those relatively well served. Those currently not seeking screening are at even higher risk of contributing to the higher mortality rate, and we need to find out how best to ensure that we can more uniformly apply screening and have the capacity to do so.

Needs assessment of cancer survivors in Connecticut.

INTRODUCTION: There are knowledge gaps regarding the needs of cancer survivors in Connecticut and their utilization of supportive services. METHODS: A convenience sample of cancer survivors residing in Connecticut were invited to complete a self-administered (print or online) needs assessment (English or Spanish). Participants identified commonly occurring problems and completed a modified version of the Supportive Care Needs Survey Short Form (SNCS-SF34) assessing needs across five domains (psychosocial, health systems/information, physical/daily living, patient care /support, and sexuality). RESULTS: The majority of the 1,516 cancer survivors (76.4%) were women, 47.5% had completed high school or some college, 66.1% were diagnosed ≤5 years ago, and 87.7% were non-Hispanic white. The breast was the most common site (47.6%), followed by the prostate, colorectal, lung, and melanoma. With multivariate adjustment, need on the SCNS-SF34 was greatest among women, younger survivors, those diagnosed within the past year, those not free of cancer, and Hispanics/Latinos. We also observed some differences by insurance and education status. In addition, we assessed the prevalence of individual problems, with the most common being weight gain/loss, memory changes, paying for care, communication, and not being told about services. CONCLUSIONS: Overall and domain specific needs in this population of cancer survivors were relatively low, although participants reported a wide range of problems. Greater need was identified among cancer survivors who were female, younger, Hispanic/Latino, and recently diagnosed. IMPLICATIONS FOR CANCER SURVIVORS: These findings can be utilized to target interventions and promote access to available resources for Connecticut cancer survivors.

Assessing the unmet information, support and care delivery needs of men with prostate cancer.

This study identified the key Unmet Needs of men with localized prostate cancer. A series of Nominal Groups were used to identify needs, from which a 135-item survey was developed to assess both the Importance and Unmet Need of each item. An Importance-Weighted Unmet Need score was calculated for each item, incorporating both the Importance and the degree to which the need was unmet. Surveys (n=500) were distributed in four geographically distinct areas, with a response rate of 46%. Respondents were 90% Caucasian, 80% married, with a mean age of 66 years, and mean education of 14 years. Care delivery needs were most important and least unmet, while Support needs were least important and most unmet. However, when degree to which needs were unmet was weighted by Importance, information needs had the highest Importance-Weighted Unmet Need scores. The greatest Unmet Needs for information were in knowledge of recurrence issues and in side effects of the illness and its treatment.