Recruitment methods to increase Hispanic participation in clinical trials.

FO01-01 Background: Cancer registries serve an essential role in making cancer data available to researchers who seek to contribute to medicine. One way to recruit ethnic minorities into clinical trials is to include more minorities into cancer registries; however, there is no research on the evaluation of minority recruitment and enrollment into these registries. For example, ethnic minorities represent 25% of the U.S. population, yet they comprise less than 10% of a national cancer genetics consortium9s participants. Objective: Because there is limited knowledge of Hispanic/Latino recruitment into cancer registries, this study aimed to identify potential Hispanic research participants from local registries who are at an increased risk for developing cancer and evaluate three potential recruitment methods to increase Hispanic enrolment in the Cancer Genetics Network. Methods: Through the NCI-supported Texas Cancer Genetics Consortium (TCGC), about 4000 Hispanic cancer registry patients were contacted, and 458 agreed to accept registration materials. After separation by gender (256 males, 202 females), they were randomly assigned to one of three conditions. Condition X1 received standard materials via mail, X2 received X1 materials plus an English/Spanish, culturally-tailored magazine on clinical trials, and X3 received X2 materials as well as tailored phone contact. A database was created to monitor the sample identification, recruitment, and follow-up activities. The completion and return of the CGN questionnaire, a signed consent form, the culturally-tailored magazine evaluation questionnaire and effectiveness of telephone contact (for X3 only), and the refusal questionnaire (if applicable) were the outcome measures for the study. Results: The response rate varied among groups. Based on the number of CGN registry forms received, the X1 recruitment method yielded 31%, the X2 yielded 25%, and the X3 yielded 37% of the total CGN recruits. The utilization of the X3 recruitment method yielded the most recruits into the CGN registry and the least refusals. Conclusion: The call for increasing minority accrual to clinical trials and other public health studies is more pronounced than ever. Certainly, language, education, and other social economic indicators have significant influence over informed decision-making for many health behaviors. It is also clear that the complexity of clinical studies, screening criteria for specific trials, and institutional human subjects protection principles and practices can be barriers to increasing rates of participation among populations with greater health disparities than those with greater education, insurance, and other financial resources. Because there is limited knowledge of Latino recruitment into cancer registries, this study sought to evaluate several standard recruitment strategies that have been used in previous research among different population groups. Therefore, strategies for recruitment of patients into cancer registries should be customized to portray the needs of particular populations. These population groups may be characterized by gender, age, ethnicity, education, income, social class, disability, geographic location, and sexual orientation. Nonetheless, further research is necessary to identify barriers and promoters of Hispanic/Latino recruitment into clinical trials and cancer registries.