"Entering a Clinical Trial: Is it Right for You?": a randomized study of The Clinical Trials Video and its impact on the informed consent process.
OBJECTIVE
This randomized study was designed to assess the utility of an educational video in preparing cancer patients for decisions about clinical trial participation. The study assessed the effect of the video on patients' understanding and perceptions of clinical trials, its impact on decision making and patient-provider communication, and patients' satisfaction with the video.


METHODS
Ninety adults considering cancer clinical trials were randomized to receive (n = 45) or not receive (n = 45) the video. Using the validated Quality of Informed Consent (QuIC), respondents' knowledge about clinical trial participation was assessed. All subjects completed additional questions about satisfaction with the video, decision making, and patient-provider communication. Data were analyzed using the Wilcoxon rank-sum test, regression model, and descriptive statistics.


RESULTS
Although intent-to-treat analysis found no significant group differences in objective understanding between those randomized to view or not view the video, the majority of participants reported favorable experiences with regard to watching the video: 85% found the video was an important source of information about clinical trials; 81% felt better prepared to discuss the trial with their physician; 89% of those who watched the video with family indicated that it helped family better understand clinical trials; and 73% indicated it helped family accept their decision about participation.


CONCLUSIONS
Although the video did not measurably improve patients' knowledge about clinical trials, it was an important source of information, helped educate families, and enhanced patient communication with their oncology providers.
Bone Marrow Transplant and Hematologic Malignancies, University of Colorado School of Medicine, University of Colorado Hospital, Denver, Colorado, USA. bhoffner@gmail.com
Brianna
B
Hoffner
Susan
S
Bauer-Wu
Suzanne
S
Hitchcock-Bryan
Mark
M
Powell
Andrew
A
Wolanski
Steven
S
Joffe
D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D003142:Communication; D003657:Decision Making; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy*; D010353:Patient Education as Topic / Q000379:methods*; D017060:Patient Satisfaction; D014743:Videotape Recording