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

Area of Science:

• Oncology
• Medical Informatics
• Health Education

Background:

• Patient participation in cancer clinical trials is hindered by a lack of knowledge and negative attitudes.
• Effective patient education is crucial to overcome these barriers and encourage trial consideration.

Purpose of the Study:

• To evaluate the efficacy of Preparatory Education About Clinical Trials (PRE-ACT), a Web-based interactive program, in improving cancer patients' understanding and attitudes towards clinical trials.
• To compare PRE-ACT's effectiveness against standard text-based information.

Main Methods:

• A prospective randomized clinical trial involving 1255 cancer patients.
• Patients were allocated to either the PRE-ACT intervention or a control group receiving National Cancer Institute (NCI) text information.
• PRE-ACT included knowledge assessment, values clarification, and tailored video content.

Main Results:

• Both PRE-ACT and control groups showed significant improvements in knowledge and attitudes from baseline.
• PRE-ACT demonstrated a significantly greater increase in knowledge and reduction in attitudinal barriers compared to the control group (P < .001).
• Preparedness to consider clinical trials increased in both groups, with a trend favoring PRE-ACT (P < .09); patient satisfaction was higher with PRE-ACT.

Conclusions:

• Pre-oncologist visit patient education significantly enhances knowledge, attitudes, and decision-making readiness for clinical trials.
• While both text and tailored video are effective, PRE-ACT's interactive video format is superior to NCI text for improving knowledge and reducing barriers.