The comparative effectiveness of decision aids in diverse populations with early stage prostate cancer: a study protocol for a cluster-randomized controlled trial in the NCI Community Oncology Research Program (NCORP), Alliance A191402CD

Joel E Pacyna, Simon Kim, Kathleen Yost, Hillary Sedlacek, Daniel Petereit, Judith Kaur, Bruce Rapkin, Robert Grubb, Electra Paskett, George J Chang, Jeff Sloan, Ethan Basch, Brittny Major, Paul Novotny, John Taylor, Jan Buckner, J Kellogg Parsons, Michael Morris, Jon C Tilburt, Joel E Pacyna, Simon Kim, Kathleen Yost, Hillary Sedlacek, Daniel Petereit, Judith Kaur, Bruce Rapkin, Robert Grubb, Electra Paskett, George J Chang, Jeff Sloan, Ethan Basch, Brittny Major, Paul Novotny, John Taylor, Jan Buckner, J Kellogg Parsons, Michael Morris, Jon C Tilburt

Abstract

Background: Treatments for localized prostate cancer present challenging tradeoffs in the face of uncertain treatment benefits. These options are best weighed in a process of shared decision-making with the patient's healthcare team. Minority men experience disparities in prostate cancer outcomes, possibly due in part to a lack of optimal communication during treatment selection. Decision aids facilitate shared decision-making, improve knowledge of treatment options, may increase satisfaction with treatment choice, and likely facilitate long-term quality of life.

Methods/design: This study will compare the effect of two evidence-based decision aids on patient knowledge and on quality of life measured one year after treatment, oversampling minority men. One decision aid will be administered prior to specialist consultation, preparing patients for a treatment discussion. The other decision aid will be administered within the consultation to facilitate transparent, preference-sensitive, and evidence-informed deliberations. The study will utilize a four-arm, block-randomized design to test whether each decision aid alone (Arms 1 and 2) or in combination (Arm 3) can improve patient knowledge and quality of life compared to usual care (Arm 4). The study, funded by the National Cancer Institute's Community Oncology Research Program (NCORP), will be deployed within select institutions that have demonstrated capacity to recruit minority populations into urologic oncology trials.

Discussion: Upon completion of the trial, we will have 1) tested the effectiveness of two evidence-based decision aids in enhancing patients' knowledge of options for prostate cancer therapy and 2) estimated whether decision aids may improve patient quality of life one year after initial treatment choice.

Trial registration: Clinicaltrials.gov: NCT03103321 . The trial registration date (on ClinicalTrials.gov) was April 6, 2017.

Keywords: Clinical trial; Decision aid; Prostate cancer; Shared decision-making.

Conflict of interest statement

Ethics approval and consent to participate

The study has been reviewed and approved by the National Cancer Institute (NCI)‘s Division of Cancer Prevention and Control (DCP) Central IRB (CIRB). Consent for trial participation will be obtained with a written consent form which has been approved by the CIRB.

Consent for publication

Not applicable.

Competing interests

The authors report no conflicts of interest in the conduct and reporting of this study.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Site Randomization
Fig. 2
Fig. 2
Prostate Cancer Treatments Questionnaire

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