Challenges of recruitment of breast cancer survivors to a randomized clinical trial for osteoporosis prevention.
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.
Kearney Division, College of Nursing, University of Nebraska Medical Center, 1917 West 24th, Kearney, NE 68849-4510, USA. cott@unmc.edu
Carol D
CD
Ott
Janice J
JJ
Twiss
Nancy L
NL
Waltman
Gloria J
GJ
Gross
Ada M
AM
Lindsey
D015502:Absorptiometry, Photon / Q000706:statistics & numerical data; D050071:Bone Density Conservation Agents / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000150:complications / Q000523:psychology*; D002118:Calcium / Q000627:therapeutic use; D012968:Etidronic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D005081:Exercise Therapy; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008137:Longitudinal Studies; D008403:Mass Screening / Q000191:economics / Q000523:psychology / Q000706:statistics & numerical data; D009042:Motivation; D009329:Nebraska; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*; D010342:Patient Acceptance of Health Care / Q000523:psychology* / Q000706:statistics & numerical data; D018579:Patient Selection; D015995:Prevalence; D016032:Randomized Controlled Trials as Topic; D000068296:Risedronic Acid; D017741:Survivors / Q000523:psychology*; D014807:Vitamin D / Q000627:therapeutic use; D014891:Weight Lifting
D050071:Bone Density Conservation Agents; D014807:Vitamin D; D000068296:Risedronic Acid; D012968:Etidronic Acid; D002118:Calcium