The Personal Patient Profile-Prostate decision support for men with localized prostate cancer: A multi-center randomized trial |
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| Authors: | Donna L Berry Barbara Halpenny Fangxin Hong Seth Wolpin William B Lober Kenneth J Russell William J Ellis Usha Govindarajulu Jaclyn Bosco B Joyce Davison Gerald Bennett Martha K Terris Andrea Barsevick Daniel W Lin Claire C Yang Greg Swanson |
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| Institution: | 1. Dana-Farber Cancer Institute, Phyllis F. Cantor Center, Boston, MA 02215, USA;2. Dana-Farber Cancer Institute, Department of Biostatistics and Computational Biology, Boston, MA 02215, USA;3. University of Washington, Biobehavioral Nursing and Health Systems, Seattle, WA 98195, USA;4. University of Washington, Biobehavioral Nursing and Health Systems, Medical Education and Biomedical Informatics, Seattle, WA 98195, USA;5. University of Washington, Department of Radiation Oncology, Seattle, WA 98195, USA;6. University of Washington, Department of Urology, Seattle, WA 98195, USA;7. Brigham and Women''s Hospital, Department of Medicine, Boston, MA 02215, USA;8. University of Saskatchewan, Saskatoon, Canada;9. Georgia Health Sciences University, College of Nursing, Charlie Norwood VA Medical Center, Research and Development Service Line, Augusta, GA 30904, USA;10. Charlie Norwood VA Medical Center, Division of Surgery, Urology Section; Georgia Health Sciences University, Department of Surgery, Section of Urology, Augusta, GA 30904, USA;11. Fox Chase Cancer Center, Philadelphia, PA 19111, USA;12. VA Puget Sound Healthcare System; University of Washington, Department of Urology, Seattle, WA 98195, USA;13. South Texas Veterans Health Care System, University of Texas Health Science Center at San Antonio, Department of Radiation Oncology, San Antonio, TX 78229, USA |
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| Abstract: | ObjectiveThe purpose of this trial was to compare usual patient education plus the Internet-based Personal Patient Profile-Prostate, vs. usual education alone, on conflict associated with decision making, plus explore time-to-treatment, and treatment choice.MethodsA randomized, multi-center clinical trial was conducted with measures at baseline, 1-, and 6 months. Men with newly diagnosed localized prostate cancer (CaP) who sought consultation at urology, radiation oncology, or multi-disciplinary clinics in 4 geographically-distinct American cities were recruited. Intervention group participants used the Personal Patient Profile-Prostate, a decision support system comprised of customized text and video coaching regarding potential outcomes, influential factors, and communication with care providers. The primary outcome, patient-reported decisional conflict, was evaluated over time using generalized estimating equations to fit generalized linear models. Additional outcomes, time-to-treatment, treatment choice, and program acceptability/usefulness, were explored.ResultsA total of 494 eligible men were randomized (266 intervention; 228 control). The intervention reduced adjusted decisional conflict over time compared with the control group, for the uncertainty score (estimate ?3.61; (confidence interval, ?7.01, 0.22), and values clarity (estimate ?3.57; confidence interval (?5.85,?1.30). Borderline effect was seen for the total decisional conflict score (estimate ?1.75; confidence interval (?3.61,0.11). Time-to-treatment was comparable between groups, while undecided men in the intervention group chose brachytherapy more often than in the control group. Acceptability and usefulness were highly rated.ConclusionThe Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized CaP. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a CaP treatment that is consistent with the patient values and preferences. |
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