Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2012 Apr 1;118(7):1877-83.
doi: 10.1002/cncr.26438. Epub 2011 Aug 25.

"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

Brianna Hoffner  1 , Susan Bauer-Wu, Suzanne Hitchcock-Bryan, Mark Powell, Andrew Wolanski, Steven Joffe
Affiliations
Randomized Controlled Trial

"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

Brianna Hoffner et al. Cancer. .

Abstract

Purpose: 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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Participant Flow Diagram
See this image and copyright information in PMC

References

    1. Kass N, Sugarman J, Talyor H, et al. Purpose and benfits of early phase clinical trials: What do oncologists say? What do patients hear? Journal of Empiral Research on Human Research Ethics. 2008;3(3):57–68. - PMC - PubMed
    1. Kass NE, Sugarman J, Medley AM, et al. An intervention to improve cancer patients’ understanding of early-phase clinical trials. Ethics and Human Research. 2009;31(3):1–10. - PMC - PubMed
    1. Hack TF, Whelan T, Olivotto IA, et al. Standardized audiotape versus recorded consultation to enhance informed consent to a clinical trial in breast oncology. Psycho-Oncology. 2007;16(4):371–376. - PubMed
    1. Lara PN, Higdon R, Lim N, et al. Prospective evaluation of cancer clinical trial accrual patterns: Identifying potential barriers to enrollment. Journal of Clinical Oncology. 2001;19(6):1728–1733. - PubMed
    1. Aaronson NK, Visser-Pol E, Leenhouts GH, et al. Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. Journal of Clinical Oncology. 1996;14(3):984–996. - PubMed

Publication types