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; Greg Swanson

doi:10.1016/j.urolonc.2011.10.004

The Personal Patient Profile-Prostate decision support for men with localized prostate cancer: a multi-center randomized trial

Urol Oncol. 2013 Oct;31(7):1012-21. doi: 10.1016/j.urolonc.2011.10.004. Epub 2011 Dec 7.

Authors

Donna L Berry¹, 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, Greg Swanson

Affiliation

¹ Dana-Farber Cancer Institute, Phyllis F. Cantor Center, Boston, MA 02215, USA. Electronic address: donna_berry@dfci.harvard.edu.

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.

Keywords: Decision making; Decisional conflict; Internet; Prostate cancer; Randomized trial.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Aged, 80 and over
Choice Behavior
Decision Making*
Health Knowledge, Attitudes, Practice*
Humans
Linear Models
Male
Middle Aged
Outcome Assessment, Health Care
Patient Education as Topic / methods*
Prospective Studies
Prostatic Neoplasms / diagnosis
Prostatic Neoplasms / therapy*

Abstract

Publication types

MeSH terms

Grants and funding