Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations.
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.
Wray
Ricardo J
RJ
Department of Community Health, Saint Louis University School of Public Health, St. Louis, MO 63104, USA. wray@slu.edu
Stryker
Jo Ellen
JE
Winer
Eric
E
Demetri
George
G
Emmons
Karen M
KM
D035843:Biomedical Research; D002986:Clinical Trials as Topic / Q000523:psychology*; D032882:Comprehension; D032962:Consent Forms; D003657:Decision Making; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy / Q000523:psychology*; D010353:Patient Education as Topic; D010358:Patient Participation / Q000523:psychology*; D010865:Pilot Projects; D035842:Research Subjects / Q000523:psychology*