Feasibility,acceptability, and effectiveness of a decision aid versus an informational website to promote clinical trial decision-making among cancer patients: A pilot randomized controlled trial |
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| Affiliation: | 1. Department of Health Outcomes and Behavior, Division of Population Science, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA;2. Department of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA;3. Department of Oncologic Sciences, Morsani College of Medicine, University of South Florida, Tampa, Florida, USA;4. Division of Surgical Oncology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida, USA;1. Department of Health Sciences, Norwegian University of Science and Technology (NTNU), Gjøvik, Norway;2. Centre of Medical Ethics, University of Oslo, Oslo, Norway;1. School of Health & Exercise Sciences, University of British Columbia, Kelowna, Canada;2. International Collaboration on Repair Discoveries (ICORD), University of British Columbia, Vancouver, Canada;3. Spinal Cord Injury BC, Vancouver, Canada;4. School of Kinesiology, Acadia University, Wolfville, Canada;5. Department of Medicine, University of British Columbia, Vancouver, Canada;6. University of British Columbia, Faculty of Medicine, Centre for Chronic Disease Prevention and Management, Kelowna, Canada;1. Department of Family Medicine, Division of community health, Faculty of health sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel;2. Department of Counseling and Human Development, Haifa University, Israel;1. Division of Hospital Medicine, University of Colorado, 12401 E 17th Avenue, Aurora, CO 80045, USA;2. Division of Hospital Medicine, University of Colorado, Denver Health, Denver, CO, USA;1. School of Medicine, Stanford University, Stanford, CA, USA;2. Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA;3. Department of Neurology and Neurological Sciences, Stanford University School of Medicine, Stanford, CA, USA;4. Department of Neurology & Neurological Sciences, Stanford University, Stanford, CA, USA;5. Department of Pediatrics, Stanford School of Medicine, Stanford, CA, USA;6. Physician Partnership Programs, Stanford Health Care, Stanford, CA, USA;7. Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, USA |
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| Abstract: | ObjectiveTo assess intervention feasibility and acceptability, and compare the effectiveness of the CHOICES Decision Aid (DA) versus the National Cancer Institute (NCI) Cancer Clinical Trials (CCT) website to improve knowledge about CCTs and preparedness to make an informed decision.MethodsOncology patients (n = 101) with a scheduled clinic visit were enrolled and randomized. Decision-making variables were collected at two timepoints. Post-intervention scores were examined via paired t-tests and multivariate regression analyses. Predictors of the magnitudes of the change in scores were examined in multivariable regression analyses.ResultsThe interventions were feasible to implement and acceptable to participants. Both interventions increased objective and subjective knowledge, improved clarity of opinions, and reduced decisional conflict (p-values < 0.01). Improvements in the belief that one could find out about CCTs were observed in the CHOICES DA arm (p < 0.001). Multivariable analyses controlling for educational attainment showed no significant differences in the magnitude of change in outcome variables between intervention arms, but did find that improvements in some variables in the NCI arm – but not CHOICES DA arm – were associated with previous educational attainment.ConclusionsInterventions were feasible to implement and acceptable. Improvements in knowledge and decision-making outcomes were observed in both arms, supporting the view that interventions to improve CCT decision making are effective and feasible. Our results suggest that the CHOICES DA may be more effective than an informational website in improving decision-making outcomes regardless of participants’ educational attainment.Practice implicationsCCT resources should support informed decision-making among all cancer survivors, regardless of educational attainment. |
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| Keywords: | Cancer patients Cancer treatment Clinical trial Decision aid Decision-making Empowerment Knowledge Values clarification Feasibility Acceptability |
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