Language as a barrier to cancer clinical trial accrual: assessing consenting team knowledge and practices for cancer clinical trial consent among low English fluency patients

Background: Low English fluency in large culturally diverse institutions may contribute to meager minority accrual. Our objective was to: 1) Assess knowledge of proper consenting procedures among the research team when consenting a low English fluency patient. 2) Assess the enrollment rate of participants in cancer therapeutic trials who identify a preferred language other than English. Methods: An anonymous web-based survey was distributed at a single institution to investigators, research staff and translator services to assess knowledge of consenting procedures. Patient enrollment data was retrieved from the clinical trials enrollment tracking system from January 2011 ­ October 2014 and matched to registration data indicating preferred language (N = 1521). The number and type of cancer cases from January 2011­October 2014 were retrieved from the institutional cancer registry and matched to registration data indicating preferred language. Results: Although there are many organizational in-person and web-based trainings focused on the requirements for consenting low English fluency patients, members of the research team responded correctly to only 64.8% (σ = 24.6%) of the knowledge-based portion of the survey. Of the 12,538 index cancer cases indentified, 10% preferred a language other than English. Trial enrollment rates for cancer clinical trials were similar for English (13%), Spanish (11%), and, Armenian (10%) speakers. Populations speaking Russian and Arabic had the lowest participation at 5% each. Conclusions: In order to increase enrollment into clinical trials, institutions must explore more effective training opportunities for research staff, engage interpreters and adopt recruitment and study materials in different languages (AU)

Germline mutation in BRCA1 or BRCA2 and ten-year survival for women diagnosed with epithelial ovarian cancer.

PURPOSE: To analyze the effect of germline mutations in BRCA1 and BRCA2 on mortality in patients with ovarian cancer up to 10 years after diagnosis. EXPERIMENTAL DESIGN: We used unpublished survival time data for 2,242 patients from two case-control studies and extended survival time data for 4,314 patients from previously reported studies. All participants had been screened for deleterious germline mutations in BRCA1 and BRCA2. Survival time was analyzed for the combined data using Cox proportional hazard models with BRCA1 and BRCA2 as time-varying covariates. Competing risks were analyzed using Fine and Gray model. RESULTS: The combined 10-year overall survival rate was 30% [95% confidence interval (CI), 28%-31%] for non-carriers, 25% (95% CI, 22%-28%) for BRCA1 carriers, and 35% (95% CI, 30%-41%) for BRCA2 carriers. The HR for BRCA1 was 0.53 at time zero and increased over time becoming greater than one at 4.8 years. For BRCA2, the HR was 0.42 at time zero and increased over time (predicted to become greater than 1 at 10.5 years). The results were similar when restricted to 3,202 patients with high-grade serous tumors and to ovarian cancer-specific mortality. CONCLUSIONS: BRCA1/2 mutations are associated with better short-term survival, but this advantage decreases over time and in BRCA1 carriers is eventually reversed. This may have important implications for therapy of both primary and relapsed disease and for analysis of long-term survival in clinical trials of new agents, particularly those that are effective in BRCA1/2 mutation carriers.