Abstract
BackgroundTreatments 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/designThis 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.DiscussionUpon 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 registrationClinicaltrials.gov: NCT03103321. The trial registration date (on ClinicalTrials.gov) was April 6, 2017.
Highlights
DiscussionUpon 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
Men with newly diagnosed localized prostate cancer face challenging treatment decisions
[26] The study will be conducted in clinical settings where patients have recently learned about their diagnosis of localized prostate cancer and are receiving their first consultation about treatment options
Summary
Preference-sensitive decisions involve uncertainty about net outcome benefit, making patient values and preferences paramount in the treatment decision. [39,40,41] Because of the lack of clinical trial data suggesting a superior initial active prostate cancer therapy, physicians should help their patients successfully deliberate about the quality of life implications and burdens of different primary treatments to reach a decision that embodies the principles of shared decision-making (SDM). Preference-sensitive decisions involve uncertainty about net outcome benefit, making patient values and preferences paramount in the treatment decision. [39,40,41] Because of the lack of clinical trial data suggesting a superior initial active prostate cancer therapy, physicians should help their patients successfully deliberate about the quality of life implications and burdens of different primary treatments to reach a decision that embodies the principles of shared decision-making (SDM). Decision aids that are sensitive to cultural norms and that enable patient-driven conversation about treatment options for prostate cancer may hold one of the keys to reducing known disparities in prostate cancer treatment and outcomes. At the conclusion of our trial, we will have data showing the impact of decisions aids on patient knowledge in a sample enriched with minority men with new diagnoses of prostate cancer
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