title: Offering participants results of a clinical trial: sharing results of a negative study.
abstract: In general, patients are not given information about the results of trials in which they have participated. We aimed to assess the process and effect of providing clinical trial participants with results of a negative study. We offered results to 135 participants in a phase II trial of breast excision alone for women with ductal carcinoma in situ, which was stopped early because of an early high rate of local recurrence. 85 (90%) of 94 respondents chose to receive results; these women were more educated (57 [67%] of 85 college graduates) than those who chose not to (two [22%] of nine, p=0.006). Most participants reported positive feelings about being offered results and about clinical trials in general. These preliminary findings from sharing clinical trial results are encouraging.
authors.affiliation: Department of Medical and Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA. ahpartridge@partners.org
authors.forename: Ann H
authors.initials: AH
authors.lastname: Partridge
authors.forename: Julia S
authors.initials: JS
authors.lastname: Wong
authors.forename: Katherine
authors.initials: K
authors.lastname: Knudsen
authors.forename: Rebecca
authors.initials: R
authors.lastname: Gelman
authors.forename: Ebonie
authors.initials: E
authors.lastname: Sampson
authors.forename: Michele
authors.initials: M
authors.lastname: Gadd
authors.forename: Karyn L
authors.initials: KL
authors.lastname: Bishop
authors.forename: Jay R
authors.initials: JR
authors.lastname: Harris
authors.forename: Eric P
authors.initials: EP
authors.lastname: Winer
mesh_terms: D001294:Attitude to Health; D001943:Breast Neoplasms / Q000523:psychology / Q000628:therapy; D002986:Clinical Trials as Topic / Q000523:psychology*; D030881:Disclosure; D004522:Educational Status; D005260:Female; D006801:Humans; D008875:Middle Aged; D035842:Research Subjects / Q000523:psychology*