title: [An index of understanding randomised clinical trials in oncology].
abstract: The first aim of this study was to build a French validated tool (ICEC-R) assessing the objective comprehension of the modalities and purposes of participating to a randomised clinical trial (phase II or III). The second goal of the study was to compare the scores different groups of participants got at the ICEC-R in accordance with their level of expertness in this domain (physicians vs patients included in a randomised CT vs patients with standard treatment vs uninformed) and to assess whether these scores of objective comprehension were, or not, impacted by the patients' anxiety state or their satisfaction about the care they receive. The sample was composed of 474 participants, namely 73 "target patients" suffering from cancer and participating to a randomised clinical trial, 97 "standard patients" suffering from cancer but who were not included in a clinical trial, 25 "physicians" who include patients in clinical trials, 18 "caregivers" who do not include patients in clinical trials, and 261 "uninformed" (psychology students). "Target" or "standard" patients received a questionnaire composed of the randomised clinical trials comprehension inventory (ICEC-R), a trait-state anxiety scale (STAI-Y), and a scale assessing their satisfaction about the care (SAT). In addition to general information, physicians, caregivers and uninformed only completed the ICEC-R. The analyzes led us to keep a one-dimensional comprehension inventory composed of ten items which are sufficiently discriminant among the patients and for which expert physicians gave consensual answers. Finally, the patients' answers to this questionnaire seem not to be influenced by either their anxiety or their satisfaction about the care. Better evaluations of the knowledge of the patients who participate to randomised clinical trials seem to be a distinct asset to improve these patients' global clinical care.
authors.affiliation: Univ. Lille Nord de France - Université de Lille-III - URECA EA 1059, BP 60149 F-59653 Villeneuve-d'Ascq Cedex, Centre Oscar-Lambret, Lille, France.
authors.forename: Tanguy
authors.initials: T
authors.lastname: Leroy
authors.forename: Véronique
authors.initials: V
authors.lastname: Christophe
authors.forename: Nicolas
authors.initials: N
authors.lastname: Penel
authors.forename: Pascal
authors.initials: P
authors.lastname: Antoine
authors.forename: Laurence
authors.initials: L
authors.lastname: Vanlemmens
authors.forename: Michel
authors.initials: M
authors.lastname: Reich
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Clisant
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety / Q000523:psychology; D017028:Caregivers; D017322:Clinical Trials, Phase II as Topic / Q000523:psychology; D017326:Clinical Trials, Phase III as Topic / Q000523:psychology; D032882:Comprehension; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D008495:Medical Oncology; D008875:Middle Aged; D009369:Neoplasms / Q000523:psychology* / Q000628:therapy; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D055815:Young Adult