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.
Ott
Carol D
CD
Kearney Division, College of Nursing, University of Nebraska Medical Center, 1917 West 24th, Kearney, NE 68849-4510, USA. cott@unmc.edu
Twiss
Janice J
JJ
Waltman
Nancy L
NL
Gross
Gloria J
GJ
Lindsey
Ada M
AM
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