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Randomized Controlled Trial
. 2021 Aug;39(8):493.e9-493.e15.
doi: 10.1016/j.urolonc.2020.11.038. Epub 2021 Jan 19.

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

Donna L Berry  1 , Fangxin Hong  2 , Traci M Blonquist  2 , Barbara Halpenny  2 , Niya Xiong  2 , Christopher P Filson  3 , Viraj A Master  4 , Martin G Sanda  5 , Peter Chang  6 , Gary W Chien  7 , Randy A Jones  8 , Tracey L Krupski  9 , Seth Wolpin  10 , Leslie Wilson  11 , Julia H Hayes  12 , Quoc-Dien Trinh  13 , Mitchell Sokoloff  14
Affiliations
Randomized Controlled Trial

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

Donna L Berry et al. Urol Oncol. 2021 Aug.

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.

Keywords: Decision regret; Decision support techniques; Prostate cancer.

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Figures

Figure 1.
Figure 1.
CONSORT diagram for Personal Patient Profile-Prostate II trial
Figure 2:
Figure 2:. Mean predicted decisional regret score for cases that chose active surveillance or definite treatment, and (A) by race (black vs others), (B) by hormonal symptom at 6-month (presence vs absence), (C) by bowel symptom at 6-month (presence vs absence)
Note: P3P=Personal Patient Profile-Prostate; UC=Usual Care EPIC-CP=Expanded Prostate Cancer Index Composite-Clinical Practice; Surv=Surveillance; Tx=Treatment
See this image and copyright information in PMC

References

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