Neal J Meropol1, Yu-Ning Wong2, Terrance Albrecht2, Sharon Manne2, Suzanne M Miller2, Anne Lederman Flamm2, Al Bowen Benson2, Joanne Buzaglo2, Michael Collins2, Brian Egleston2, Linda Fleisher2, Michael Katz2, Tyler G Kinzy2, Tasnuva M Liu2, Seunghee Margevicius2, Dawn M Miller2, David Poole2, Nancy Roach2, Eric Ross2, Mark D Schluchter2. 1. Neal J. Meropol, University Hospitals Case Medical Center Seidman Cancer Center; Neal J. Meropol, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller, and Mark D. Schluchter, Case Comprehensive Cancer Center, Case Western Reserve University; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Yu-Ning Wong, Suzanne M. Miller, Michael Collins, Brian Egleston, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania Health System, Philadelphia, PA; Terrance Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Sharon Manne, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz, International Myeloma Foundation, North Hollywood, CA; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA Neal.Meropol@case.edu. 2. Neal J. Meropol, University Hospitals Case Medical Center Seidman Cancer Center; Neal J. Meropol, Tyler G. Kinzy, Tasnuva M. Liu, Seunghee Margevicius, Dawn M. Miller, and Mark D. Schluchter, Case Comprehensive Cancer Center, Case Western Reserve University; Anne Lederman Flamm, Cleveland Clinic Foundation, Cleveland, OH; Yu-Ning Wong, Suzanne M. Miller, Michael Collins, Brian Egleston, and Eric Ross, Fox Chase Cancer Center, Temple University Health System; Joanne Buzaglo, Cancer Support Community Research and Training Institute; Linda Fleisher, Children's Hospital of Philadelphia; David Poole, University of Pennsylvania Health System, Philadelphia, PA; Terrance Albrecht, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Sharon Manne, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Al Bowen Benson III, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Michael Katz, International Myeloma Foundation, North Hollywood, CA; and Nancy Roach, Fight Colorectal Cancer, Alexandria, VA.
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.
RCT Entities:
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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