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

Carol D. Ott, Janice J Twiss, Nancy Lauraine Waltman, Gloria J. Gross, Ada M. Lindsey

Research output: Contribution to journalArticle

26 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)21-33
Number of pages13
JournalCancer Nursing
Volume29
Issue number1
DOIs
StatePublished - Jan 1 2006

Fingerprint

Osteoporosis
Survivors
Randomized Controlled Trials
Breast Neoplasms
Costs and Cost Analysis
Fitness Centers
X-Rays
Clinical Trials
Bone and Bones
Telephone

Keywords

  • Breast cancer survivors
  • Osteoporosis
  • Progressive strength
  • Randomized clinical trial
  • Recruitment
  • Rural versus urban
  • Training

ASJC Scopus subject areas

  • Oncology
  • Oncology(nursing)

Cite this

Challenges of recruitment of breast cancer survivors to a randomized clinical trial for osteoporosis prevention. / Ott, Carol D.; Twiss, Janice J; Waltman, Nancy Lauraine; Gross, Gloria J.; Lindsey, Ada M.

In: Cancer Nursing, Vol. 29, No. 1, 01.01.2006, p. 21-33.

Research output: Contribution to journalArticle

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