1. Decision regret, adverse outcomes, and treatment choice in men with localized prostate cancer: Results from a multi-site randomized trial
- Author
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Berry, Donna L, Hong, Fangxin, Blonquist, Traci M, Halpenny, Barbara, Xiong, Niya, Filson, Christopher P, Master, Viraj A, Sanda, Martin G, Chang, Peter, Chien, Gary W, Jones, Randy A, Krupski, Tracey L, Wolpin, Seth, Wilson, Leslie, Hayes, Julia H, Trinh, Quoc-Dien, and Sokoloff, Mitchell
- Subjects
Male ,Urologic Diseases ,Aging ,Emotions ,Decision Making ,Clinical Trials and Supportive Activities ,Oncology and Carcinogenesis ,Long Term Adverse Effects ,Choice Behavior ,Decision Support Techniques ,Decision regret ,Clinical Research ,Surveys and Questionnaires ,Behavioral and Social Science ,Humans ,Cancer ,Prostate cancer ,Decision support techniques ,Prostate Cancer ,Prevention ,Prostatic Neoplasms ,Urology & Nephrology ,Prognosis ,Combined Modality Therapy ,Good Health and Well Being ,Patient Safety ,Delivery of Health Care ,Follow-Up Studies - Abstract
IntroductionMen diagnosed with localized prostate cancer must navigate a highly preference-sensitive decision between treatment options with varying adverse outcome profiles. We evaluated whether use of a decision support tool previously shown to decrease decisional conflict also impacted the secondary outcome of post-treatment decision regret.MethodsParticipants were randomized to receive personalized decision support via the Personal Patient Profile-Prostate or usual care prior to a final treatment decision. Symptoms were measured just before randomization and 6 months later; decision regret was measured at 6 months along with records review to ascertain treatment choices. Regression modeling explored associations between baseline variables including race and D`Amico risk, study group, and 6-month variables regret, choice, and symptoms.ResultsAt 6 months, 287 of 392 (73%) men returned questionnaires of which 257 (89%) had made a treatment choice. Of that group, 201 of 257 (78%) completely answered the regret scale. Regret was not significantly different between participants randomized to the P3P intervention compared to the control group (P = 0.360). In univariate analyses, we found that Black men, men with hormonal symptoms, and men with bowel symptoms reported significantly higher decision regret (all P < 0.01). Significant interactions were detected between race and study group (intervention vs. usual care) in the multivariable model; use of the Personal Patient Profile-Prostate was associated with significantly decreased decisional regret among Black men (P = 0.037). Interactions between regret, symptoms and treatment revealed that (1) men choosing definitive treatment and reporting no hormonal symptoms reported lower regret compared to all others; and (2) men choosing active surveillance and reporting bowel symptoms had higher regret compared to all others.ConclusionThe Personal Patient Profile-Prostate decision support tool may be most beneficial in minimizing decisional regret for Black men considering treatment options for newly-diagnosed prostate cancer.Trial registrationNCT01844999.
- Published
- 2021