The personal patient profile-prostate decision support for men with localized prostate cancer: A multi-center randomized trial

Donna L. Berry, Barbara Halpenny, Fangxin Hong, Seth Wolpin, William B. Lober, Kenneth J. Russell, William J. Ellis, Usha Govindarajulu, Jaclyn Bosco, B. Joyce Davison, Gerald Bennett, Martha K. Terris, Andrea Barsevick, Daniel W. Lin, Claire C. Yang, Gregory P Swanson

Research output: Contribution to journalArticle

56 Citations (Scopus)

Abstract

Objective: The purpose of this trial was to compare usual patient education plus the Internet-based Personal Patient Profile-Prostate, vs. usual education alone, on conflict associated with decision making, plus explore time-to-treatment, and treatment choice. Methods: A randomized, multi-center clinical trial was conducted with measures at baseline, 1-, and 6 months. Men with newly diagnosed localized prostate cancer (CaP) who sought consultation at urology, radiation oncology, or multi-disciplinary clinics in 4 geographically-distinct American cities were recruited. Intervention group participants used the Personal Patient Profile-Prostate, a decision support system comprised of customized text and video coaching regarding potential outcomes, influential factors, and communication with care providers. The primary outcome, patient-reported decisional conflict, was evaluated over time using generalized estimating equations to fit generalized linear models. Additional outcomes, time-to-treatment, treatment choice, and program acceptability/usefulness, were explored. Results: A total of 494 eligible men were randomized (266 intervention; 228 control). The intervention reduced adjusted decisional conflict over time compared with the control group, for the uncertainty score (estimate -3.61; (confidence interval, -7.01, 0.22), and values clarity (estimate -3.57; confidence interval (-5.85,-1.30). Borderline effect was seen for the total decisional conflict score (estimate -1.75; confidence interval (-3.61,0.11). Time-to-treatment was comparable between groups, while undecided men in the intervention group chose brachytherapy more often than in the control group. Acceptability and usefulness were highly rated. Conclusion: The Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized CaP. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a CaP treatment that is consistent with the patient values and preferences.

Original languageEnglish (US)
Pages (from-to)1012-1021
Number of pages10
JournalUrologic Oncology: Seminars and Original Investigations
Volume31
Issue number7
DOIs
StatePublished - Oct 2013

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Prostate
Prostatic Neoplasms
Confidence Intervals
Uncertainty
Therapeutics
Control Groups
Radiation Oncology
Patient Preference
Brachytherapy
Urology
Patient Education
Internet
Patient Selection
Linear Models
Decision Making
Referral and Consultation
Communication
Conflict (Psychology)
Clinical Trials
Education

Keywords

  • Decision making
  • Decisional conflict
  • Internet
  • Prostate cancer
  • Randomized trial

ASJC Scopus subject areas

  • Oncology
  • Urology

Cite this

The personal patient profile-prostate decision support for men with localized prostate cancer : A multi-center randomized trial. / Berry, Donna L.; Halpenny, Barbara; Hong, Fangxin; Wolpin, Seth; Lober, William B.; Russell, Kenneth J.; Ellis, William J.; Govindarajulu, Usha; Bosco, Jaclyn; Davison, B. Joyce; Bennett, Gerald; Terris, Martha K.; Barsevick, Andrea; Lin, Daniel W.; Yang, Claire C.; Swanson, Gregory P.

In: Urologic Oncology: Seminars and Original Investigations, Vol. 31, No. 7, 10.2013, p. 1012-1021.

Research output: Contribution to journalArticle

Berry, DL, Halpenny, B, Hong, F, Wolpin, S, Lober, WB, Russell, KJ, Ellis, WJ, Govindarajulu, U, Bosco, J, Davison, BJ, Bennett, G, Terris, MK, Barsevick, A, Lin, DW, Yang, CC & Swanson, GP 2013, 'The personal patient profile-prostate decision support for men with localized prostate cancer: A multi-center randomized trial', Urologic Oncology: Seminars and Original Investigations, vol. 31, no. 7, pp. 1012-1021. https://doi.org/10.1016/j.urolonc.2011.10.004
Berry, Donna L. ; Halpenny, Barbara ; Hong, Fangxin ; Wolpin, Seth ; Lober, William B. ; Russell, Kenneth J. ; Ellis, William J. ; Govindarajulu, Usha ; Bosco, Jaclyn ; Davison, B. Joyce ; Bennett, Gerald ; Terris, Martha K. ; Barsevick, Andrea ; Lin, Daniel W. ; Yang, Claire C. ; Swanson, Gregory P. / The personal patient profile-prostate decision support for men with localized prostate cancer : A multi-center randomized trial. In: Urologic Oncology: Seminars and Original Investigations. 2013 ; Vol. 31, No. 7. pp. 1012-1021.
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abstract = "Objective: The purpose of this trial was to compare usual patient education plus the Internet-based Personal Patient Profile-Prostate, vs. usual education alone, on conflict associated with decision making, plus explore time-to-treatment, and treatment choice. Methods: A randomized, multi-center clinical trial was conducted with measures at baseline, 1-, and 6 months. Men with newly diagnosed localized prostate cancer (CaP) who sought consultation at urology, radiation oncology, or multi-disciplinary clinics in 4 geographically-distinct American cities were recruited. Intervention group participants used the Personal Patient Profile-Prostate, a decision support system comprised of customized text and video coaching regarding potential outcomes, influential factors, and communication with care providers. The primary outcome, patient-reported decisional conflict, was evaluated over time using generalized estimating equations to fit generalized linear models. Additional outcomes, time-to-treatment, treatment choice, and program acceptability/usefulness, were explored. Results: A total of 494 eligible men were randomized (266 intervention; 228 control). The intervention reduced adjusted decisional conflict over time compared with the control group, for the uncertainty score (estimate -3.61; (confidence interval, -7.01, 0.22), and values clarity (estimate -3.57; confidence interval (-5.85,-1.30). Borderline effect was seen for the total decisional conflict score (estimate -1.75; confidence interval (-3.61,0.11). Time-to-treatment was comparable between groups, while undecided men in the intervention group chose brachytherapy more often than in the control group. Acceptability and usefulness were highly rated. Conclusion: The Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized CaP. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a CaP treatment that is consistent with the patient values and preferences.",
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AU - Wolpin, Seth

AU - Lober, William B.

AU - Russell, Kenneth J.

AU - Ellis, William J.

AU - Govindarajulu, Usha

AU - Bosco, Jaclyn

AU - Davison, B. Joyce

AU - Bennett, Gerald

AU - Terris, Martha K.

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