Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials

Overview

Journal J Clin Oncol

Specialty Oncology

Date 2015 Dec 25

PMID 26700123

Citations 52

Authors

Neal J Meropol

Yu-Ning Wong

Terrance Albrecht

Sharon Manne

Suzanne M Miller

Anne Lederman Flamm

Al Bowen Benson 3rd

Joanne Buzaglo

Michael Collins

Brian Egleston

Linda Fleisher

Michael Katz

Tyler G Kinzy

Tasnuva M Liu

Seunghee Margevicius

Dawn M Miller

David Poole

Nancy Roach

Eric Ross

Mark D Schluchter

Affiliations

Soon will be listed here.

Abstract

Purpose: Lack of knowledge and negative attitudes have been identified as barriers to participation in clinical trials by patients with cancer. We developed Preparatory Education About Clinical Trials (PRE-ACT), a theory-guided, Web-based, interactive computer program, to deliver tailored video educational content to patients in an effort to overcome barriers to considering clinical trials as a treatment option.

Patients And Methods: A prospective, randomized clinical trial compared PRE-ACT with a control condition that provided general clinical trials information produced by the National Cancer Institute (NCI) in text format. One thousand two hundred fifty-five patients with cancer were randomly allocated before their initial visit with an oncologist to PRE-ACT (n = 623) or control (n = 632). PRE-ACT had three main components: assessment of clinical trials knowledge and attitudinal barriers, values assessment with clarification back to patients, and provision of a video library tailored to address each patient's barriers. Outcomes included knowledge and attitudes and preparation for decision making about clinical trials.

Results: Both PRE-ACT and control interventions improved knowledge and attitudes (all P < .001) compared with baseline. Patients randomly allocated to PRE-ACT showed a significantly greater increase in knowledge (P < .001) and a significantly greater decrease in attitudinal barriers (P < .001) than did their control (text-only) counterparts. Participants in both arms significantly increased their preparedness to consider clinical trials (P < .001), and there was a trend favoring the PRE-ACT group (P < .09). PRE-ACT was also associated with greater patient satisfaction than was NCI text alone.

Conclusion: These data show that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials. Both text and tailored video were effective. The PRE-ACT interactive video program was more effective than NCI text in improving knowledge and reducing attitudinal barriers.

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