Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations

J Cancer Educ. 2007 Spring;22(1):21-4. doi: 10.1007/BF03174370.

Abstract

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biomedical Research
  • Clinical Trials as Topic / psychology*
  • Comprehension*
  • Consent Forms
  • Decision Making*
  • Female
  • Humans
  • Informed Consent / psychology*
  • Male
  • Middle Aged
  • Neoplasms / drug therapy
  • Neoplasms / psychology*
  • Patient Education as Topic
  • Patient Participation / psychology*
  • Pilot Projects
  • Research Subjects / psychology*