Challenges of recruitment of breast cancer survivors to a randomized clinical trial for osteoporosis prevention.

ABSTRACT

Recruitment of participants was a challenging issue for a statewide, 4-site, randomized, longitudinal trial for osteoporosis prevention. The accrual goal was 273 healthy breast cancer survivors. This federally funded study included a home-based followed by a fitness center-based 24-month intervention with follow-up at 36 months. In this report, recruitment planning, monitoring, and modifications are described, and the cost per enrolled participant is identified. Monthly monitoring of accrual numbers per recruitment strategy at each of 4 catchment areas allowed for early identification of necessary changes in recruitment strategies. Modifications were necessary when only 39% of the overall accrual goal had been attained at the 66% time point into the 18-month recruitment phase. Successful recruitment strategies were intensified, and new strategies were implemented, addressing motivators and deterrents for participation in clinical trials. Because approximately 81% of women were demonstrating bone loss via free dual energy x-ray absorptiometry screening, prevalence of the bone loss problem in survivors was incorporated into the recruitment information. Of 708 women screened via telephone and laboratory/dual energy x-ray absorptiometry testing, 249 were enrolled with 67% at 2 metropolitan sites and 33% at 2 rural sites. Recruitment media costs were approximately US$35 per enrolled participant. When combined with skeletal and laboratory screening, costs were approximately US$480 per enrolled participant. Tracking recruitment efforts in large clinical trials should be ongoing, site-specific, and cost-effective. Changes incorporated early in the recruitment phase addressed unique aspects of rural versus metropolitan areas and resulted in near achievement of accrual goals.