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.

Effects of physical activity on common side effects of breast cancer treatment

“…Notably, in 20 of the studies, a combination of resistance and aerobic training was applied. With respect to the prescription of resistance training, only nine studies described the number of sets and repetitions, and among the 10 studies reporting exercise intensities, intensities ranged anywhere from 30-60% of to 60-85% of 1RM, which is not consistent with the resistance training guidelines recommended by the American College of Sports Medicine (i.e., one set of [8][9][10][11][12] repetitions to the point of volitional fatigue). With regard to the aerobic exercises, treadmill walking and stationary cycling were the most frequently prescribed sessions.…”

“…However, motivating women with breast cancer to engage in regular physical activity may be an enormous challenge given the posttreatment fatigue resulting from chemotherapy and other treatments, as well as other side effects of breast cancer treatment [8]. Some of the common side effects of breast cancer treatment include fatigue [9], depression [10], bone loss [11], decreased levels of muscular strength [12], decreased aerobic capacity [13], increased weight gain [14,15], and ultimately, impaired quality of life [16]. Consequently, researchers have investigated the effects of regular participation in physical activity as a therapeutic intervention for targeting these commonly occurring side effects of breast cancer adjuvant therapies.…”

The Kuala Lumpur Qigong Trial for Women in the Cancer Survivorship Phase-Efficacy of a Three-Arm RCT to Improve QOL

“…In addition, this calls for greater efforts to reduce the risk of cancer recurrence and chronic diseases, and improve wellness and survival. Increasing evidence are suggesting that physically active cancer survivors have better QoL compared to sedentary patients (Demark-Wahnefried et al, 2001;ott et al, 2006;IOM, 2007). There is a growing evidence that physical activity have additional positive benefits such as prolonged survival (Schmitz et al, 2010), reduced risk of recurrence (Hayes et al, 2009), reduced breast density (milne et al, 2007), improved physical fitness (ohira et al, 2006) and improvement from fatigue (Valance et al, 2007).…”

The effect of weight training on bone mineral density and bone turnover in postmenopausal breast cancer survivors with bone loss: a 24-month randomized controlled trial

“…The 24 month analysis included 223 women (exercise: n=110 and medication only: n=113). Challenges in recruitment are described elsewhere [25]. Mean (SD) subject age was 58.69 (7.5) years, time since menopause was 7.52 (7.7) years, and time since completion of breast cancer treatment (surgery, radiation therapy, and/ or chemotherapy) was 5.95 (6.1) years.…”