BACKGROUND: Accepted practices of informed consent often result in suboptimal patient understanding of research studies. METHODS: This pilot study aimed to assess trial-specific tailored materials, compared to a widely used generic booklet about clinical trials, randomly assigned to 118 candidates for cancer clinical trials. Study outcomes were: satisfaction with decision-making; satisfaction with materials; and subjective understanding of the clinical trial. RESULTS: There were no major differences between groups. Participants rated tailored materials higher as a useful reference. CONCLUSIONS: Trial-specific materials hold utility for reference during clinical trials. Studies of informed consent are feasible, although important factors limit research.
RCT Entities:
BACKGROUND: Accepted practices of informed consent often result in suboptimal patient understanding of research studies. METHODS: This pilot study aimed to assess trial-specific tailored materials, compared to a widely used generic booklet about clinical trials, randomly assigned to 118 candidates for cancer clinical trials. Study outcomes were: satisfaction with decision-making; satisfaction with materials; and subjective understanding of the clinical trial. RESULTS: There were no major differences between groups. Participants rated tailored materials higher as a useful reference. CONCLUSIONS: Trial-specific materials hold utility for reference during clinical trials. Studies of informed consent are feasible, although important factors limit research.
Authors: N K Aaronson; E Visser-Pol; G H Leenhouts; M J Muller; A C van der Schot; F S van Dam; R B Keus; C C Koning; W W ten Bokkel Huinink; J A van Dongen; R Dubbelman Journal: J Clin Oncol Date: 1996-03 Impact factor: 44.544
Authors: M Holmes-Rovner; J Kroll; N Schmitt; D R Rovner; M L Breer; M L Rothert; G Padonu; G Talarczyk Journal: Med Decis Making Date: 1996 Jan-Mar Impact factor: 2.583
Authors: Cathy A Coyne; Ronghui Xu; Peter Raich; Kathy Plomer; Mark Dignan; Lari B Wenzel; Diane Fairclough; Thomas Habermann; Linda Schnell; Susan Quella; David Cella Journal: J Clin Oncol Date: 2003-03-01 Impact factor: 44.544