Donna L Berry1, Fangxin Hong2, Traci M Blonquist2, Barbara Halpenny2, Niya Xiong2, Christopher P Filson3, Viraj A Master4, Martin G Sanda5, Peter Chang6, Gary W Chien7, Randy A Jones8, Tracey L Krupski9, Seth Wolpin10, Leslie Wilson11, Julia H Hayes12, Quoc-Dien Trinh13, Mitchell Sokoloff14. 1. Dana-Farber Cancer Institute, Boston, MA; University of Washington School of Nursing, Seattle, WA. Electronic address: donnalb@uw.edu. 2. Dana-Farber Cancer Institute, Boston, MA. 3. Department of Urology, Emory University School of Medicine, Atlanta, GA; Winship Cancer Institute, Emory Healthcare, Atlanta, GA; Atlanta VA Medical Center, Decatur, GA. 4. Department of Urology, Emory University School of Medicine, Atlanta, GA; Winship Cancer Institute, Emory Healthcare, Atlanta, GA. 5. Department of Urology, Emory University School of Medicine, Atlanta, GA. 6. Beth Israel Deaconess Medical Center, Boston, MA. 7. Department of Urology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA. 8. University of Virginia School of Nursing, Charlottesville, VA. 9. University of Virginia School of Medicine, Charlottesville, VA. 10. University of Washington School of Nursing, Seattle, WA. 11. Department of Clinical Pharmacy, University of California, San Francisco, San Francisco, CA. 12. Dana-Farber Cancer Institute at St. Elizabeth's Medical Center, Boston, MA. 13. Department of Urology, Brigham and Women's Hospital, Boston, MA. 14. Department of Urology, University of Massachusetts Medical Center, Worchester, MA.
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.
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.
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