PURPOSE: Barriers to clinical trial participation among African American cancer patients are well characterized in the literature. Attitudinal barriers encompassing fear, distrust, and concerns about ethical misconduct are also well documented. To increase trial accrual, these attitudes must be adequately addressed, yet there remains a lack of targeted interventions toward this end. We developed a 15-minute culturally targeted video designed to impact six specific attitudes of African American cancer patients toward therapeutic trials. We conducted a pilot study to test in the first such intervention to increase intention to enroll. PATIENTS AND METHODS: The primary study outcome was self-reported likelihood to participate in a therapeutic trial. Using a mixed methods approach, we developed the Attitudes and Intention to Enroll in Therapeutic Clinical Trials (AIET) instrument, a 30-item questionnaire measuring six attitudinal barriers to African American trial participation. We enrolled 108 eligible active treatment patients at a large urban cancer institute. McNemar's test for matched pairs was used to assess changes in attitudes and likelihood to enroll in a clinical trial at baseline and immediately after the video. Pre- and post-video AIET summative scores were analyzed by paired t-test for each attitudinal barrier. RESULTS: Patients' likelihood of enrolling in a clinical trial significantly increased post-video with 36% of the sample showing positive changes in intention [McNemar's χ(2) = 33.39, p < .001]. Paired t-tests showed significant changes in all six attitudinal barriers measured via AIET summative scores from pre- to post-video. CONCLUSION: These data suggest utility of our video for increasing African American participation in clinical trials.
PURPOSE: Barriers to clinical trial participation among African American cancerpatients are well characterized in the literature. Attitudinal barriers encompassing fear, distrust, and concerns about ethical misconduct are also well documented. To increase trial accrual, these attitudes must be adequately addressed, yet there remains a lack of targeted interventions toward this end. We developed a 15-minute culturally targeted video designed to impact six specific attitudes of African American cancerpatients toward therapeutic trials. We conducted a pilot study to test in the first such intervention to increase intention to enroll. PATIENTS AND METHODS: The primary study outcome was self-reported likelihood to participate in a therapeutic trial. Using a mixed methods approach, we developed the Attitudes and Intention to Enroll in Therapeutic Clinical Trials (AIET) instrument, a 30-item questionnaire measuring six attitudinal barriers to African American trial participation. We enrolled 108 eligible active treatment patients at a large urban cancer institute. McNemar's test for matched pairs was used to assess changes in attitudes and likelihood to enroll in a clinical trial at baseline and immediately after the video. Pre- and post-video AIET summative scores were analyzed by paired t-test for each attitudinal barrier. RESULTS:Patients' likelihood of enrolling in a clinical trial significantly increased post-video with 36% of the sample showing positive changes in intention [McNemar's χ(2) = 33.39, p < .001]. Paired t-tests showed significant changes in all six attitudinal barriers measured via AIET summative scores from pre- to post-video. CONCLUSION: These data suggest utility of our video for increasing African American participation in clinical trials.
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Authors: Kathleen B Cartmell; Heather S Bonilha; Terri Matson; Debbie C Bryant; Jane G Zapka; Tricia A Bentz; Marvella E Ford; Chanita Hughes-Halbert; Kit N Simpson; Anthony J Alberg Journal: Contemp Clin Trials Commun Date: 2016-08-15