Phase I participants' views of quality of life and trial participation burdens.


Journal Article

PURPOSE: Participants' perception of quality of life (QOL) and respondent burden have significant implications for investigators' ethical responsibilities to their subjects in phase I cancer trials. To address these responsibilities, analysis was conducted on participants' views of their experiences of a phase I trial, including the associated burdens and what constitutes QOL. PATIENTS AND METHODS: One hundred potential participants of the endostatin trial were surveyed. Sixteen of the 18 trial participants were interviewed extensively about their experiences on the trial. RESULTS: Participants described 'normality' as a baseline ability to function, be productive, and be free from symptoms of disease and side effects of treatment. Reflecting the relative nontoxicity of the study drug, participants contrasted their current QOL with their negative experience of previous cancer treatments and viewed their QOL as fairly good. However, participants emphasized that indirect and procedural burdens of trial participation had a significant impact on their current QOL. CONCLUSIONS: Candid descriptions of a trial's practical demands, in addition to potential physical complications in a trial, could improve the quality of informed consent.

Full Text

Duke Authors

Cited Authors

  • Cohen, MZ; Slomka, J; Pentz, RD; Flamm, AL; Gold, D; Herbst, RS; Abbruzzese, JL

Published Date

  • July 2007

Published In

Volume / Issue

  • 15 / 7

Start / End Page

  • 885 - 890

PubMed ID

  • 17252219

Pubmed Central ID

  • 17252219

International Standard Serial Number (ISSN)

  • 0941-4355

Digital Object Identifier (DOI)

  • 10.1007/s00520-007-0216-0


  • eng

Conference Location

  • Germany