Originally published as JCO Early Release 10.1200/JCO.2006.08.9367 on May 29 2007

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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

Claire Julian-Reynier, Jean Genève, Florence Dalenc, Dominique Genre, Alain Monnier, Pierre Kerbrat, Rémy Largillier, Daniel Serin, Maria Rios, Henri Roché, Marta Jimenez, Carole Tarpin, Dominique Maraninchi

From the Institut National de la Santé et de la Recherche Médicale, U379, Epidemiology and Social Sciences Unit; Aix Marseille Université, Faculté des Sciences/de Médecine; Paoli-Calmettes Institute, Marseille; Fédération Nationale des Centres de Lutte contre le Cancer, Paris; Claudius Regaud Institute, Toulouse; André Boulloche Centre, Montbéliard; Eugène Marquis Centre, Rennes; Antoine Lacassagne Centre, Nice; Sainte Catherine Institute, Avignon; and the Alexis Vautrin Centre, Vandoeuvre-Lès-Nancy, France

Address reprint requests to Claire Julian-Reynier, MD, Institut National de la Santé et de la Recherche Médicale, U379, 232 Bd Ste Marguerite,13273 Marseille Cedex 09, France; e-mail: julian{at}marseille.inserm.fr

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 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.

published online ahead of print at www.jco.org on May 29, 2007.

Supported by the Ligue Nationale Contre le Cancer, the Fondation de France, and the Fédération Nationale des Centres de Lutte Contre le Cancer.

Presented in part in poster format at the 41st Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 13-17, 2005.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.