ARTICLESChallenges of Recruitment of Breast Cancer Survivors to a Randomized Clinical Trial for Osteoporosis PreventionOtt, Carol D. RN, OCN®, PhD; Twiss, Janice J. APRN, PhD; Waltman, Nancy L. APRN, PhD; Gross, Gloria J. RN, PhD; Lindsey, Ada M. RN, PhD, FAANAuthor Information From the Kearney Division (Dr Ott), Omaha Division (Dr Twiss), Lincoln Division (Dr Waltman), Scottsbluff Division (Dr Gross), and Dean Emeritus (Dr Lindsey), College of Nursing, University of Nebraska Medical Center, Kearney, Neb. The author discloses she has received grant/research support from Wyeth Consumer Health Care, Aventis Pharmaceuticals, NIH-National Institute of Nursing Research. Funding source: National Institutes of Health NINR 1 R01 NR07743-01A1. Corresponding author: Carol D. Ott, RN, OCN, PhD, College of Nursing, University of Nebraska Medical Center, 1917 West 24th, Kearney, NE 68849-4510 (email: [email protected]). Accepted for publication July 26, 2005. Cancer Nursing: January 2006 - Volume 29 - Issue 1 - p 21-31 Buy Take the CE Test 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. © 2006 Lippincott Williams & Wilkins, Inc.