Understanding participation in a trial comparing cryotherapy and radiation treatment.

ABSTRACT

BACKGROUND: To date, few two-arm active treatment randomized control trials (RCTs) have compared prostate cancer therapies. OBJECTIVE: To examine the difference and similarities between the reasons for accepting and declining participation in a two-arm active treatment RCT comparing external beam radiation therapy (EBRT) versus cryotherapy. METHODS: Eleven men with prostate cancer, selected purposively, participated in a 30-minute post-treatment semi-structured interview. Interviews were transcribed verbatim, coded and analyzed for patterns with the assistance of the text management (TM) software (NVivo). RESULTS: RCT accepters participated principally with the hope of being randomized into the cryotherapy treatment arm. Consequently, randomization into the EBRT arm was often perceived as receiving the consolation prize. RCT decliners were either pushed away from cryotherapy and/or pulled towards another treatment (surgery, EBRT, brachytherapy). Factors influencing accepters'/decliners' treatment decisions include (1) personal factors such as patient research and treatment preference, cancer survivors, family/friends, and altruism, and (2) physician, trial, and treatment factors such as patient-physician rapport, RCT awareness and understanding, therapy convenience, expected outcome and perceived side effects. CONCLUSIONS: By better understanding patients' views about RCT participation, recruitment rates for prostate cancer RCTs can be improved.