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/m(2) 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 refusal group, 3.68 +\- 0.87; control group, 3.41 +\- 0.82; P <= .02) and the doctors' communication ( average +\- SD: RCT acceptance group, 3.56 +\- 0.88; RCT refusal group, 3.67 +\- 0.88; control group, 3.39 +\- 0.84; P <= .05) higher than those to whom the trial was not proposed. After the treatment, participants in the RCT felt that their doctor was more supportive ( average +\- SD: RCT acceptance group, 3.04 +\- 0.92; control group, 2.77 +\- 0.85; P = .005) and more informative about their illness and treatment ( average +\- SD: RCT acceptance group, 3.34 +\- 0.88; control group, 3.08 +\- 0.92; P = .006) than those in the control group. The general level of satisfaction was also higher in the RCT acceptance group. Conclusion Women participating in an RCT have a more positive picture of their doctors' care than others, probably because of the structural effects of the informed consent and data collection processes.