title: 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.
abstract: OBJECTIVE
  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.
  
  
  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 < or = .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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Institut National de la Santé et de la Recherche Médicale, U379, Epidemiology and Social Sciences Unit, Marseille, France. julian@marseille.inserm.fr
authors.forename: Claire
authors.initials: C
authors.lastname: Julian-Reynier
authors.forename: Jean
authors.initials: J
authors.lastname: Genève
authors.forename: Florence
authors.initials: F
authors.lastname: Dalenc
authors.forename: Dominique
authors.initials: D
authors.lastname: Genre
authors.forename: Alain
authors.initials: A
authors.lastname: Monnier
authors.forename: Pierre
authors.initials: P
authors.lastname: Kerbrat
authors.forename: Rémy
authors.initials: R
authors.lastname: Largillier
authors.forename: Daniel
authors.initials: D
authors.lastname: Serin
authors.forename: Maria
authors.initials: M
authors.lastname: Rios
authors.forename: Henri
authors.initials: H
authors.lastname: Roché
authors.forename: Marta
authors.initials: M
authors.lastname: Jimenez
authors.forename: Carole
authors.initials: C
authors.lastname: Tarpin
authors.forename: Dominique
authors.initials: D
authors.lastname: Maraninchi
mesh_terms: D000328:Adult; D000367:Age Factors; D000704:Analysis of Variance; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D005069:Evaluation Studies as Topic; D005260:Female; D005602:France; D006801:Humans; D016015:Logistic Models; D008875:Middle Aged; D009367:Neoplasm Staging; D010349:Patient Compliance / Q000706:statistics & numerical data*; D017060:Patient Satisfaction; D011336:Probability; D011379:Prognosis; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D018570:Risk Assessment; D012959:Socioeconomic Factors; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D016896:Treatment Outcome; D016312:Treatment Refusal / Q000706:statistics & numerical data*