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

BMC Cancer

Bruce Rapkin¹  Brittny Major²  Jeff Sloan²  George J. Chang³  Paul Novotny⁴  Jan Buckner⁴  Jon C. Tilburt⁴  Joel E. Pacyna⁴  Judith Kaur⁴  Kathleen Yost⁴  Robert Grubb⁵  Michael Morris⁶  J. Kellogg Parsons⁷  Electra Paskett⁸  Daniel Petereit⁹  Hillary Sedlacek^1,10  Simon Kim^1,10  John Taylor^1,11  Ethan Basch^1,12 

[1] Albert Einstein Cancer Center;Alliance Statistics And Data Center, Mayo Clinic;MD Anderson Cancer Center;Mayo Clinic;Medical University of South Carolina;Memorial Sloan Kettering Cancer Center;Moores UC San Diego Comprehensive Cancer Center;Ohio State University;Regional Health;University Hospitals, Case Western Reserve University;University of Chicago;University of North Carolina;

关键词: Prostate cancer;    Clinical trial;    Decision aid;    Shared decision-making;   

DOI  :  10.1186/s12885-018-4672-3

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown