TY - JOUR
T1 - Association of Treatment Modality, Functional Outcomes, and Baseline Characteristics with Treatment-Related Regret among Men with Localized Prostate Cancer
AU - Wallis, Christopher J.D.
AU - Zhao, Zhiguo
AU - Huang, Li Ching
AU - Penson, David F.
AU - Koyama, Tatsuki
AU - Kaplan, Sherrie H.
AU - Greenfield, Sheldon
AU - Luckenbaugh, Amy N.
AU - Klaassen, Zachary
AU - Conwill, Ralph
AU - Goodman, Michael
AU - Hamilton, Ann S.
AU - Wu, Xiao Cheng
AU - Paddock, Lisa E.
AU - Stroup, Antoinette
AU - Cooperberg, Matthew R.
AU - Hashibe, Mia
AU - O'Neil, Brock B.
AU - Hoffman, Karen E.
AU - Barocas, Daniel A.
N1 - Funding Information:
Funding/Support: This study was supported by grants 1R01HS019356 and 1R01HS022640 from the AHRQ, grant CE-12-11-4667 from the PCORI, and grant R01CA230352 from the NCI. Data management was facilitated by Vanderbilt University’s Research Electronic Data Capture (REDCap) system, which is supported by the Vanderbilt Institute for Clinical and Translational Research grant UL1TR000011 from the National Center for Advancing Translational Sciences.
Funding Information:
receiving personal fees from Janssen Canada outside the submitted work. Dr Penson reported receiving grants from Patient-Centered Outcomes Research Institute (PCORI), Agency for Healthcare Research and Quality (AHRQ), and National Cancer Institute (NCI) during the conduct of the study. Dr Hamilton reported receiving grants from NCI/ Vanderbilt subcontract during the conduct of the study. Dr Paddock reported receiving a subaward to recruit cases and perform abstraction of medical record and tumor registry data from Vanderbilt University Medical School–Rutgers New Jersey State Cancer Registry during the conduct of the study. Dr Cooperberg reported receiving personal fees from Dendreon, Astellas Pharma Inc, AstraZeneca, Bayer AG, Merck & Co, Inc, Veracyte, Inc, Exact Sciences Corp, and Janssen Pharmaceuticals outside the submitted work. Dr Hashibe reported receiving grants from the NCI during the conduct of the study. Dr Hoffman reported receiving grants from Varian Medical Systems and Janssen Pharmaceuticals outside the submitted work. Dr Barocas reported receiving grants from the NCI, AHRQ, and PCORI during the conduct of the study and personal fees from Progenics Pharmaceuticals, Inc, and Ambu A/S advisory boards outside the submitted work. No other disclosures were reported.
Publisher Copyright:
© 2022 American Medical Association. All rights reserved.
PY - 2022/1
Y1 - 2022/1
N2 - Importance: Treatment-related regret is an integrative, patient-centered measure that accounts for morbidity, oncologic outcomes, and anxiety associated with prostate cancer diagnosis and treatment. Objective: To assess the association between treatment approach, functional outcomes, and patient expectations and treatment-related regret among patients with localized prostate cancer. Design, Setting, and Participants: This population-based, prospective cohort study used 5 Surveillance, Epidemiology, and End Results (SEER)-based registries in the Comparative Effectiveness Analysis of Surgery and Radiation cohort. Participants included men with clinically localized prostate cancer from January 1, 2011, to December 31, 2012. Data were analyzed from August 2, 2020, to March 1, 2021. Exposures: Prostate cancer treatments included surgery, radiotherapy, and active surveillance. Main Outcomes and Measures: Patient-reported treatment-related regret using validated metrics. Regression models were adjusted for demographic and clinicopathologic characteristics, treatment approach, and patient-reported functional outcomes. Results: Among the 2072 men included in the analysis (median age, 64 [IQR, 59-69] years), treatment-related regret at 5 years after diagnosis was reported in 183 patients (16%) undergoing surgery, 76 (11%) undergoing radiotherapy, and 20 (7%) undergoing active surveillance. Compared with active surveillance and adjusting for baseline differences, active treatment was associated with an increased likelihood of regret for those undergoing surgery (adjusted odds ratio [aOR], 2.40 [95% CI, 1.44-4.01]) but not radiotherapy (aOR, 1.53 [95% CI, 0.88-2.66]). When mediation by patient-reported functional outcomes was considered, treatment modality was not independently associated with regret. Sexual dysfunction, but not other patient-reported functional outcomes, was significantly associated with regret (aOR for change in sexual function from baseline, 0.65 [95% CI, 0.52-0.81]). Subjective patient-perceived treatment efficacy (aOR, 5.40 [95% CI, 2.15-13.56]) and adverse effects (aOR, 5.83 [95% CI, 3.97-8.58]), compared with patient expectations before treatment, were associated with treatment-related regret. Other patient characteristics at the time of treatment decision-making, including participatory decision-making tool scores (aOR, 0.80 [95% CI, 0.69-0.92]), social support (aOR, 0.78 [95% CI, 0.67-0.90]), and age (aOR, 0.78 [95% CI, 0.62-0.97]), were significantly associated with regret. Results were comparable when assessing regret at 3 years rather than 5 years. Conclusions and Relevance: The findings of this cohort study suggest that more than 1 in 10 patients with localized prostate cancer experience treatment-related regret. The rates of regret appear to differ between treatment approaches in a manner that is mediated by functional outcomes and patient expectations. Treatment preparedness that focuses on expectations and treatment toxicity and is delivered in the context of shared decision-making should be the subject of future research to examine whether it can reduce regret..
AB - Importance: Treatment-related regret is an integrative, patient-centered measure that accounts for morbidity, oncologic outcomes, and anxiety associated with prostate cancer diagnosis and treatment. Objective: To assess the association between treatment approach, functional outcomes, and patient expectations and treatment-related regret among patients with localized prostate cancer. Design, Setting, and Participants: This population-based, prospective cohort study used 5 Surveillance, Epidemiology, and End Results (SEER)-based registries in the Comparative Effectiveness Analysis of Surgery and Radiation cohort. Participants included men with clinically localized prostate cancer from January 1, 2011, to December 31, 2012. Data were analyzed from August 2, 2020, to March 1, 2021. Exposures: Prostate cancer treatments included surgery, radiotherapy, and active surveillance. Main Outcomes and Measures: Patient-reported treatment-related regret using validated metrics. Regression models were adjusted for demographic and clinicopathologic characteristics, treatment approach, and patient-reported functional outcomes. Results: Among the 2072 men included in the analysis (median age, 64 [IQR, 59-69] years), treatment-related regret at 5 years after diagnosis was reported in 183 patients (16%) undergoing surgery, 76 (11%) undergoing radiotherapy, and 20 (7%) undergoing active surveillance. Compared with active surveillance and adjusting for baseline differences, active treatment was associated with an increased likelihood of regret for those undergoing surgery (adjusted odds ratio [aOR], 2.40 [95% CI, 1.44-4.01]) but not radiotherapy (aOR, 1.53 [95% CI, 0.88-2.66]). When mediation by patient-reported functional outcomes was considered, treatment modality was not independently associated with regret. Sexual dysfunction, but not other patient-reported functional outcomes, was significantly associated with regret (aOR for change in sexual function from baseline, 0.65 [95% CI, 0.52-0.81]). Subjective patient-perceived treatment efficacy (aOR, 5.40 [95% CI, 2.15-13.56]) and adverse effects (aOR, 5.83 [95% CI, 3.97-8.58]), compared with patient expectations before treatment, were associated with treatment-related regret. Other patient characteristics at the time of treatment decision-making, including participatory decision-making tool scores (aOR, 0.80 [95% CI, 0.69-0.92]), social support (aOR, 0.78 [95% CI, 0.67-0.90]), and age (aOR, 0.78 [95% CI, 0.62-0.97]), were significantly associated with regret. Results were comparable when assessing regret at 3 years rather than 5 years. Conclusions and Relevance: The findings of this cohort study suggest that more than 1 in 10 patients with localized prostate cancer experience treatment-related regret. The rates of regret appear to differ between treatment approaches in a manner that is mediated by functional outcomes and patient expectations. Treatment preparedness that focuses on expectations and treatment toxicity and is delivered in the context of shared decision-making should be the subject of future research to examine whether it can reduce regret..
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U2 - 10.1001/jamaoncol.2021.5160
DO - 10.1001/jamaoncol.2021.5160
M3 - Article
C2 - 34792527
AN - SCOPUS:85120080861
VL - 8
SP - 50
EP - 59
JO - JAMA oncology
JF - JAMA oncology
SN - 2374-2437
IS - 1
ER -