Discordant attitudes and beliefs about cancer clinical trial participation between physicians, research staff, and cancer patients.

BACKGROUND/AIMS: Essential to bringing innovative cancer treatments to patients is voluntary participation in clinical trials but approximately 8% of American cancer patients are enrolled onto a trial. We used a domain-oriented framework to assess barriers to cancer clinical trial enrollment. METHODS: Physicians (MD, DO, fellows, residents) and research staff (physician assistants, nurse practitioners, staff and research nurses, clinical assistants, and program coordinators) involved in clinical research at a comprehensive cancer center completed an online survey in 2017; adult cancer patients not currently enrolled in a trial were interviewed in 2018. To inform the construct of our physician/staff and patient surveys and to assess barriers to clinical trial enrollment, we first conducted in-depth interviews among 14 key informants representing medical, hematologic, gynecologic, neurologic, radiation oncology, as well as members of the clinical research team (one clinical research coordinator, one research nurse practitioner). Perceived structural, provider- and patient-level barriers to clinical trial enrollment were assessed. Differences in perceptions, attitudes, and beliefs toward clinical trial enrollment between (1) physicians and staff, (2) patients by ethnicity, and (3) physicians/staff and patients were examined. RESULTS: In total, 120 physicians/staff involved in clinical research (39.2% physicians, 60.8% staff; 48.0% overall response rate) and 150 cancer patients completed surveys. Nearly three-quarters of physician/staff respondents reported difficulty in keeping track of the eligibility criteria for open studies but was more often cited by physicians than staff (84.4% vs 64.3%, p = 0.02). Physicians more often reported lack of time to present clinical trial information than did staff(p < 0.001); 44.0% of staff versus 18.2% of physicians reported patient family interaction as a clinical trial enrollment barrier (p = 0.007). Hispanic patients more often stated they would join a trial, even if standard therapy was an option compared to non-Hispanic patients (47.7% vs 20.8%, p = 0.002). Comparing the beliefs and perceptions of physicians/staff to those of patients, patients more often reported negative beliefs about clinical trial enrollment (e.g. being in a trial does not help patients personally, 32.9% vs 1.8%, p < 0.001) but less often felt they had no other options when agreeing to join (38.1% vs 85.6%, p < 0.001), and less often refused clinical trial enrollment due to lack of understanding (9.1% vs 63.3%, p = 0.001) than reported by physicians/staff. CONCLUSION: Our findings indicate a wide gap between physician/staff and patient attitudes and beliefs about clinical trial enrollment and highlight the importance of focusing future initiatives to raise awareness of this incongruency. Reconciling these differences will require tailored education to reduce implicit biases and dispel misperceptions. Strategies to improve the quality of patient-provider communication and address infrastructure and resource issues are also needed to improve patient enrollment onto cancer clinical trials.

Electronic Communication Channel Use and Health Information Source Preferences Among Latinos in Northern Manhattan.

Understanding key health concepts is crucial to participation in Precision Medicine initiatives. In order to assess methods to develop and disseminate a curriculum to educate community members in Northern Manhattan about Precision Medicine, clients from a local community-based organization were interviewed during 2014-2015. Health literacy, acculturation, use of Internet, email, and text messaging, and health information sources were assessed. Associations between age and outcomes were evaluated; multivariable analysis used to examine the relationship between participant characteristics and sources of health information. Of 497 interviewed, 29.4 % had inadequate health literacy and 53.6 % had access to the Internet, 43.9 % to email, and 45.3 % to text messaging. Having adequate health literacy was associated with seeking information from a healthcare professional (OR 2.59, 95 % CI 1.54-4.35) and from the Internet (OR 3.15, 95 % CI 1.97-5.04); having ≤ grade school education (OR 2.61, 95 % CI 1.32-5.17) also preferred information from their provider; persons >45 years (OR 0.29, 95 % CI 0.18-0.47) were less likely to use the Internet for health information and preferred printed media (OR 1.64, 95 % CI 1.07-2.50). Overall, electronic communication channel use was low and varied significantly by age with those ≤45 years more likely to utilize electronic channels. Preferred sources of health information also varied by age as well as by health literacy and educational level. This study demonstrates that to effectively communicate key Precision Medicine concepts, curriculum development for Latino community members of Northern Manhattan will require attention to health literacy, language preference and acculturation and incorporate more traditional communication channels for older community members.

Breast Cancer Chemoprevention among High-risk Women and those with Ductal Carcinoma In Situ.

Chemoprevention with the anti-estrogens, tamoxifen, raloxifene, and aromatase inhibitors, reduce breast cancer incidence in high-risk women; however, uptake has been poor (<5%) in the prevention setting. We assessed use of anti-estrogens for breast cancer prevention, among high-risk women seen at an academic breast center, to observe how uptake rates compare in this setting. We collected data on demographics, breast cancer risk factors, and health behaviors via self-administered questionnaires and medical chart abstraction. Women eligible for chemoprevention with anti-estrogens had a 5-year predicted breast cancer risk according to the Gail model of ≥1.67%, history of lobular or ductal carcinoma in situ (LCIS/DCIS), and/or BRCA mutation. We dichotomized anti-estrogen use as ever or never. Predictors of use were evaluated using multivariable log-binomial regression. Of 412 high-risk women enrolled, 316 (77%) were eligible for chemoprevention. Among eligible women, 55% were non-Hispanic white, 29% Hispanic, 8% non-Hispanic black, and 7% Asian. Women were grouped based upon their highest category of breast cancer risk (in descending order): BRCA mutation carriers (3%), DCIS (40%), LCIS (22%), and 5-year Gail risk ≥1.67% (36%). Among those eligible for chemoprevention, 162 (51%) had ever initiated anti-estrogen therapy (71% tamoxifen, 23% raloxifene, 5% aromatase inhibitor). Anti-estrogen use was highest among women with DCIS (73%). In multivariable analysis, women with a 5-year Gail risk ≥1.67% had approximately a 20% lower likelihood of anti-estrogen use compared to women with DCIS (p = 0.01). In the primary prevention setting, excluding women diagnosed with DCIS, anti-estrogen use was 37%. Multivariable analysis showed differences in uptake by education and potentially by race/ethnicity. Among high-risk women seen at a breast center, anti-estrogen use for chemoprevention was relatively high as compared to the published literature. Clinicians can support high-risk women by effectively communicating breast cancer risk and enhancing knowledge about the risks and benefits of chemoprevention.

Factors Associated with False Positive Results on Screening Mammography in a Population of Predominantly Hispanic Women.

Background: Potential harms of screening mammography include false positive results, such as recall breast imaging or biopsies.Methods: We recruited women undergoing screening mammography at Columbia University Medical Center in New York, New York. They completed a questionnaire on breast cancer risk factors and permitted access to their medical records. Breast cancer risk status was determined using the Gail model and a family history screener. High risk was defined as a 5-year invasive breast cancer risk of ≥1.67% or eligible for BRCA genetic testing. False positive results were defined as recall breast imaging (BIRADS score of 0, 3, 4, or 5) and/or biopsies that did not yield breast cancer.Results: From November 2014 to October 2015, 2,361 women were enrolled and 2,019 were evaluable, of whom 76% were Hispanic and 10% non-Hispanic white. Fewer Hispanic women met high-risk criteria for breast cancer than non-Hispanic whites (18.0% vs. 68.1%), but Hispanics more frequently engaged in annual screening (71.9% vs. 60.8%). Higher breast density (heterogeneously/extremely dense vs. mostly fat/scattered fibroglandular densities) and more frequent screening (annual vs. biennial) were significantly associated with false positive results [odds ratio (OR), 1.64; 95% confidence interval (CI), 1.32-2.04 and OR, 2.18; 95% CI, 1.70-2.80, respectively].Conclusions: We observed that women who screened more frequently or had higher breast density were at greater risk for false positive results. In addition, Hispanic women were screening more frequently despite having a lower risk of breast cancer compared with whites.Impact: Our results highlight the need for risk-stratified screening to potentially minimize the harms of screening mammography. Cancer Epidemiol Biomarkers Prev; 27(4); 446-53. ©2018 AACR.

Barriers to Recruitment and Adherence in a Randomized Controlled Diet and Exercise Weight Loss Intervention Among Minority Breast Cancer Survivors.

Minority recruitment to cancer trials is low and there are limited data on minority adherence to lifestyle modification interventions. We examined factors related to recruitment and adherence to a pilot weight loss intervention among Hispanic and black breast cancer survivors. Participants completed a detailed screening interview to assess barriers to enrollment. An index was created to assess adherence at 6 months. 112 potentially eligible women were identified; 66 consented and completed a screening interview. After screening, 9 were ineligible; 15 opted to not enroll; and 42 were randomized. Among eligible women, earlier stage at diagnosis, treatment type, and negative beliefs related to exercise and diet after diagnosis were negatively associated with study enrollment (P < 0.05). Self-reported barriers to adherence included fatigue, family responsibilities, illness, work, transportation, and negative perceptions of exercise and diet. Results from this study emphasize the need to adapt recruitment and adherence strategies to address these factors.