Psychosocial Factors That Influence a Woman's Decision to Enroll in a Clinical Trial: Implications on How to Improve Clinical Trial Enrollment Among Black Women.

PURPOSE: Black women with breast cancer often present with more aggressive disease compared with other races, contributing to an increased risk of cancer mortality. Despite this inequity, Black women remain severely underrepresented in breast cancer clinical trials. We aim to characterize factors that influence a woman's decision to enroll in a clinical trial, with the goal of identifying clinical interventions to aid in the recruitment of vulnerable groups. METHODS AND MATERIALS: A cross-sectional, descriptive study was conducted using a questionnaire adapted from 2 prevalidated surveys investigating factors influencing clinical trial enrollment. The survey was administered to women with curable breast cancer during a single follow-up visit at 4 different sites within a university medical system where all patients are screened for clinical trial eligibility. Chi-square tests and Mann-Whitney U tests were used to assess associations or differences between the populations. RESULTS: One hundred ninety-four out of 209 women completed the survey, giving a compliance rate of 93%. Twenty-six percent of women self-identified as Black, most women were located at community sites (67.1%), most women had diagnoses of early-stage disease (I: 57.7%, II: 29.4%), and 81% of women had some collegiate-level education. Black women were younger at diagnosis (P = .005) and less likely to be married (P = .012) but more often lived with family members (P = .003) and had a lower median income (P < .001). According to the survey, Black women were less likely to trust their care team (P = .032), more likely to believe that research ultimately harms minorities (P < .001), and had a stronger belief in God's will determining illness and wellness (P < .001). Recurring themes of trust in the health care team, patient education, and advancement of cancer treatments were discussed in the focus groups. CONCLUSIONS: Failure to offer clinical trials and mistrust in research institutions may pose the greatest hindrances to the enrollment of Black women in clinical trials. Empowering women through education and fostering trustworthy relationships can encourage greater clinical trial participation.

Identifying Psychosocial Needs of Patients With Cancer Undergoing Curative Radiation Therapy in an Inner-City Academic Center to Address Racial Disparities.

PURPOSE: There are little data quantifying the psychosocial needs of patients with cancer undergoing definitive radiation therapy. These needs significantly affect patients' access to care and treatment outcomes. Thus, our study aimed to characterize the socioeconomic needs of patients with cancer treated at an academic institution in urban and suburban radiation clinics. METHODS AND MATERIALS: A prospective, cross-sectional analysis was performed of patients undergoing curative radiation therapy for head and neck, lung/thoracic, gynecologic, or gastrointestinal malignancies using a questionnaire consolidated from prevalidated surveys. Main outcomes were differences in psychosocial needs stratified by race (Black vs non-Black) and time point (pretreatment, 1 month, 6 months, and 1 year after completion of radiation treatment). χ2 and Mann-Whitney U testing determined statistical differences between selected variables. Binary logistic regression analysis identified predictors of certain socioeconomic needs. RESULTS: Two hundred twenty-one of 266 patients completed the survey, giving a compliance rate of 83%. Black patients were more likely to be single (79% vs 37%; P < .001), reside in zip codes with a lower median income (74% vs 42%; P < .001), and be seen at our inner-city photon location (60% vs 25%; P < .001) compared with non-Black patients. Significantly higher proportions of Black compared with non-Black patients had unmet needs regarding pain (67% vs 39%; P = .005), stress management (64.7% vs 43.3%; P = .009), transportation (64% vs 19%; P < .001), and smoking cessation (35% vs 8.7%; P < .001) when all time points were considered. On multivariate analysis, Black patients were 2.6, 2.2, 7.2, and 3.4 times more likely than non-Black patients to request assistance with pain, stress, transportation, and financial aid, respectively. CONCLUSIONS: We identified disparate psychosocial needs of our cancer population, where Black patients had greater unmet needs than non-Black patients. By doing so, we plan to develop pragmatic, targeted interventions that, when combined with guideline-concordant cancer care, can lead to improvements in cancer outcomes and quality of life before, during, and after radiation therapy.

Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: the Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol.

INTRODUCTION: A broad range of stakeholders have called for randomised evidence on the potential clinical benefits and harms of proton therapy, a type of radiation therapy, for patients with breast cancer. Radiation therapy is an important component of curative treatment, reducing cancer recurrence and extending survival. Compared with photon therapy, the international treatment standard, proton therapy reduces incidental radiation to the heart. Our overall objective is to evaluate whether the differences between proton and photon therapy cardiac radiation dose distributions lead to meaningful reductions in cardiac morbidity and mortality after treatment for breast cancer. METHODS: We are conducting a large scale, multicentre pragmatic randomised clinical trial for patients with breast cancer who will be followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life and cancer control outcomes. A total of 1278 patients with non-metastatic breast cancer will be randomly allocated to receive either photon or proton therapy. The primary outcomes are major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease. Secondary endpoints are urgent or unanticipated outpatient or emergency room visits for heart failure, arrhythmia, valvular disease or pericardial disease. The Radiotherapy Comparative Effectiveness (RadComp) Clinical Events Centre will conduct centralised, blinded adjudication of primary outcome events. ETHICS AND DISSEMINATION: The RadComp trial has been approved by the institutional review boards of all participating sites. Recruitment began in February 2016. Current version of the protocol is A3, dated 08 November 2018. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement efforts and presentation to the public via lay media outlets. TRIAL REGISTRATION NUMBER: NCT02603341.

Young unmarried men's understanding of female hormonal contraception.

BACKGROUND: A better understanding of men's attitudes, norms and behaviors regarding women's use of hormonal contraception is needed. STUDY DESIGN: We conducted contraceptive life-history interviews with 41 ethnically diverse males ages 18-25 years which detailed up to six heterosexual relationships, focusing on knowledge, attitudes, norms and behaviors regarding hormonal contraception use, decision making and communication. RESULTS: Men's attitudes, norms and behaviors associated with hormonal contraceptive decisions and use varied greatly across participants and their relationships. Findings suggest a mixture of attitudes and practices regarding the importance of communication around contraception influenced by sexual experiences, age and relationship type. Many men demonstrated limited knowledge about contraceptives and identified improving contraceptive knowledge as an essential step in facilitating contraceptive communication. CONCLUSIONS: Increased awareness about young men's understanding of and perceived roles regarding hormonal contraception will help in designing services that address contraceptive adherence, contraceptive communication and incorrect or inadequate contraceptive knowledge.