Decision regret, adverse outcomes, and treatment choice in men with localized prostate cancer: Results from a multi-site randomized trial

• Type of Material: Article
• Authors: Donna L Berry, Dana-Farber Cancer Institute; Fangxin Hong, Dana-Farber Cancer Institute; Traci M Blonquist, Dana-Farber Cancer Institute; Barbara Halpenny, Dana-Farber Cancer Institute; Niya Xiong, Dana-Farber Cancer Institute; Christopher Filson, Emory University; Viraj Master, Emory University; Martin Sanda, Emory University; Peter Chang, Beth Israel Deaconess Medical Center; Gary W Chien, Kaiser Permanente Los Angeles Med Ctr; Randy A Jones, University of Virginia; Tracey L Krupski, University of Virginia; Seth Wolpin, University of Washington; Leslie Wilson, University of California San Francisco; Julia H Hayes, Dana Farber Cancer Institute; Quoc-Dien Trinh, Brigham and Women’s Hospital; Mitchell Sokoloff, University of Massachusetts Medical Center
• Language: English
• Date: 2021-08-01
• Publisher: ELSEVIER SCIENCE INC
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2020 Elsevier Inc. All rights reserved.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.urolonc.2020.11.038
• Title of Journal or Parent Work: UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS
• Volume: 39
• Issue: 8
• Start Page: 493.e9
• End Page: 493.e15
• Grant/Funding Information: National Institutes of Health, National Institute for Nursing Research R01NR009692
• Keywords: Science & Technology; Decision regret; CARE; Urology & Nephrology; Decision support techniques; Oncology; INDEX COMPOSITE; VALIDATION; INSTRUMENT; QUALITY-OF-LIFE; SATISFACTION; Prostate cancer; AID; Life Sciences & Biomedicine

Abstract

Introduction: Men 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. Methods: Participants 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. Results: At 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. Conclusion: The 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 Registration: NCT01844999