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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. 2018 Aug 06; 18(1):788.BC

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.

Authors+Show Affiliations

Mayo Clinic, Rochester, MN, USA.University Hospitals, Case Western Reserve University, Cleveland, OH, USA.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.Alliance Statistics And Data Center, Mayo Clinic, Rochester, MN, USA.Mayo Clinic, Rochester, MN, USA.University of Chicago, Chicago, IL, USA.Mayo Clinic, Rochester, MN, 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. tilburt.jon@mayo.edu.

Pub Type(s)

Clinical Trial Protocol
Comparative Study
Journal Article

Language

eng

PubMed ID

30081846

Citation

Pacyna, Joel E., et al. "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, vol. 18, no. 1, 2018, p. 788.
Pacyna JE, Kim S, Yost K, et al. 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. 2018;18(1):788.
Pacyna, J. E., Kim, S., Yost, K., Sedlacek, H., Petereit, D., Kaur, J., Rapkin, B., Grubb, R., Paskett, E., Chang, G. J., Sloan, J., Basch, E., Major, B., Novotny, P., Taylor, J., Buckner, J., Parsons, J. K., Morris, M., & Tilburt, J. C. (2018). 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, 18(1), 788. https://doi.org/10.1186/s12885-018-4672-3
Pacyna JE, et al. 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. 2018 Aug 6;18(1):788. PubMed PMID: 30081846.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Pacyna,Joel E, AU - Kim,Simon, AU - Yost,Kathleen, AU - Sedlacek,Hillary, AU - Petereit,Daniel, AU - Kaur,Judith, AU - Rapkin,Bruce, AU - Grubb,Robert, AU - Paskett,Electra, AU - Chang,George J, AU - Sloan,Jeff, AU - Basch,Ethan, AU - Major,Brittny, AU - Novotny,Paul, AU - Taylor,John, AU - Buckner,Jan, AU - Parsons,J Kellogg, AU - Morris,Michael, AU - Tilburt,Jon C, Y1 - 2018/08/06/ PY - 2018/03/26/received PY - 2018/07/17/accepted PY - 2018/8/8/entrez PY - 2018/8/8/pubmed PY - 2019/1/8/medline KW - Clinical trial KW - Decision aid KW - Prostate cancer KW - Shared decision-making SP - 788 EP - 788 JF - BMC cancer JO - BMC Cancer VL - 18 IS - 1 N2 - 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. SN - 1471-2407 UR - https://www.unboundmedicine.com/medline/citation/30081846/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_ L2 - https://bmccancer.biomedcentral.com/articles/10.1186/s12885-018-4672-3 DB - PRIME DP - Unbound Medicine ER -