Patient satisfaction with participation in a randomized exercise trial : Effects of randomization and a usual care posttrial exercise program

Background Participation in an exercise trial is a major commitment for cancer survivors, but few exercise trials have evaluated patient satisfaction with trial participation. Purpose To examine patient satisfaction with participation in the Healthy Exercise for Lymphoma Patients (HELP) Trial and to explore possible determinants. Methods The HELP Trial randomized 122 lymphoma patients to 12 weeks of supervised aerobic exercise training (AET; n = 60) or to usual care (UC; n = 62), with the option of participating in a 4-week posttrial exercise program. At the 6-month follow-up assessment, participants evaluated their overall trial satisfaction. Results Personal satisfaction with trial participation was strongly influenced by group assignment with participants randomized to AET reporting participation to be more rewarding (p < 0.001) and personally useful (p < 0.001) than participants randomized to UC. UC participants who completed the optional 4-week posttrial exercise program reported participation to be more rewarding (p = 0.008) and personally useful (p < 0.001) than UC participants who declined the program. Limitations The study is limited by the lack of a validated measure of participant satisfaction, and the fact that the offer of participation in the posttrial exercise program to the UC group was not randomized. Conclusions Lymphoma patients randomized to UC viewed it as less rewarding and personally useful despite being offered a 4-week posttrial exercise program. UC participants who completed the 4-week program reported personal satisfaction levels similar to the AET group; however, the causal direction of this association is unknown. Researchers should continue to evaluate participant satisfaction in exercise trials.