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

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.

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.

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.

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

BMC cancer. 2018 Aug 06*** epublish ***

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

Mayo Clinic, Rochester, MN, USA., University Hospitals, Case Western Reserve University, Cleveland, OH, USA., Regional Health, Rapid City, SD, USA., Mayo Clinic, Jacksonville, FL, USA., Albert Einstein Cancer Center, Bronx, NY, USA., Medical University of South Carolina, Charleston, SC, USA., Ohio State University, Columbus, OH, USA., MD Anderson Cancer Center, Houston, TX, USA., Alliance Statistics And Data Center, Mayo Clinic, Rochester, MN, USA., University of North Carolina, Chapel Hill, North Carolina, USA., University of Chicago, Chicago, IL, USA., Moores UC San Diego Comprehensive Cancer Center, San Diego, CA, USA., Memorial Sloan Kettering Cancer Center, New York, NY, USA., Mayo Clinic, Rochester, MN, USA. .

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