Abstract

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• 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.