Patient entry into randomized controlled trials of colorectal cancer treatment: factors influencing participation.

Abstract

The objective of this study was to investigate willingness to participate in hypothetical surgical randomized controlled trials (RCTs) among patients and clinicians, who answered as if they themselves were patients. We interviewed consecutive patients with colorectal cancer admitted for surgery at a tertiary center in Sydney, Australia. We mailed a questionnaire to all colorectal surgeons and medical oncologists in Australia. Overall, 42% (95% CI, 32% to 52%) of patients, 44% (95% CI, 29% to 60%) of surgeons, and 63% (95% CI, 53% to 72%) of oncologists were willing to enter a randomized clinical trial. Oncologists were significantly more likely to participate than either surgeons (P <.001) or patients (P =.001). No significant associations were seen between willingness to participate and patient characteristics. "Risk of cancer recurrence" was rated by the most patients and doctors as an important reason for refusal of trial entry, although patients additionally identified dislike of randomization and quality of life concerns as important barriers. More than 40% of patients were willing to enter into a hypothetical RCT involving surgery. Aversion to randomization and perceptions of differential impact of treatment on cancer recurrence and quality of life are likely to be major barriers to patient accrual in trials of colorectal cancer treatment.