Identifying, Recruiting, and Enrolling Adolescent Survivors of Childhood Cancer into a Randomized Controlled Trial of Health Promotion: Preliminary Experiences in the Survivor Health and Resilience Education (SHARE) Program

摘要

Objective To report on the identification, recruitment, and enrollment of adolescent survivors of childhood cancer into an ongoing randomized controlled trial (RCT) of health promotion. Methods A total of 244 adolescents were contacted by mail and telephone to assess their trial eligibility. Data were collected with respect to each adolescent’s demographics and trial recruitment efforts (frequency and intensity of telephone call contact); exclusion and randomization status were tracked throughout. Results Thirty-one percent of adolescents were ultimately randomized in the trial and 69% were excluded from randomization (13% were ineligible, 33% refused to participate, 22% were unreachable or nonresponsive, that is, did not respond to trial mailings or telephone calls, and less than 1% were withdrawn prior to randomization). Among all eligible adolescents, the trial’s consent rate was 49%. Adolescents excluded owing to refusal resided the farthest away from the intervention site and experienced the least amount of telephone call contact time. The primary reasons for trial refusal were lack of interest in health promotion (28%) and lack of time to participate (23%). Conclusions Health promotion RCTs among adolescent survivors of childhood cancer may help prevent and control the onset and severity cancer-treatment–related late effects. However, trial success may be contingent upon tracing nonresponsive adolescents and reducing and eliminating barriers to participation.