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

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.

Application of best practice approaches for designing decision support tools: The preparatory education about clinical trials (PRE-ACT) study

“…However, this approach requires considerable resources of time and an abiding commitment of the research team. The investment in structured development of web-based educational tools will hopefully increase the likelihood of success when these interventions are subjected to formal evaluation in randomized comparisons to existing standard approaches [50]. …”

Barriers to Clinical Trial Enrollment in Racial and Ethnic Minority Patients with Cancer

“…70,71 A multicenter, randomized trial of a web-based, interactive, educational tool was designed to increase knowledge, decrease attitudinal barriers, and improve preparation for making decisions about clinical trial enrollment among minority patients with cancer. 70 At baseline, the level of knowledge about clinical trials, attitudinal barriers to participation, and preparation for decision-making among the participants were assessed.…”

“…70,71 A multicenter, randomized trial of a web-based, interactive, educational tool was designed to increase knowledge, decrease attitudinal barriers, and improve preparation for making decisions about clinical trial enrollment among minority patients with cancer. 70 At baseline, the level of knowledge about clinical trials, attitudinal barriers to participation, and preparation for decision-making among the participants were assessed. 70 Prior to their initial visit with an oncologist, patients in the intervention arm watched a set of brief, individually tailored videos addressing knowledge and attitudinal barriers to clinical trial participation, whereas those assigned to the control arm received text-based general information about clinical trials from the National Cancer Institute.…”

Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program

“…After we received a CCEP participant's completed survey, we sent a survey to a matched, non-CCEP trial participant.We asked participants to report their financial concerns in the prior 3 months and barriers to clinical trial participation they experienced when considering trial enrollment. The survey contained items from previously validated questions about barriers to clinical trial participation [32][33][34][35][36][37].…”