Assessment of Care by Breast Cancer Patients Participating or Not Participating in a Randomized Controlled Trial: A Report With the Patients' Committee for Clinical Trials of the Ligue Nationale Contre le Cancer

Purpose Cancer patients participating in randomized controlled trials (RCTs) have not been found to have better clinical outcomes than other patients. Our objective was to assess the impact of RCTs on patients' satisfaction with care. Patients and Methods A prospective study was carried out in a cohort of women with breast cancer (N = 455) divided into those invited to participate in an RCT (201 acceptances, 66 refusals) and a comparable control group not invited to participate (n = 188). All the patients underwent the same treatment (fluorouracil, epirubicin, and cyclophosphamide 100 mg/m2 for six cycles). One and 7 months after the beginning of chemotherapy, self-administered satisfaction scores were used to compare the women's assessment of their care (Comprehensive Assessment of Satisfaction with Care validated scale). Results At the beginning of chemotherapy, women to whom RCT had been proposed rated the doctors' availability (average ± standard deviation [SD]: RCT acceptance group, 3.60 ± 0.78; RCT ...