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.
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.
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DOI：
10.1186/s12885-018-4672-3
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发表时间：
2018-08-06
期刊：
影响因子：
3.8
通讯作者：
Tilburt JC
中科院分区：
文献类型：
--
作者：
Pacyna JE;Kim S;Yost K;Sedlacek H;Petereit D;Kaur J;Rapkin B;Grubb R;Paskett E;Chang GJ;Sloan J;Basch E;Major B;Novotny P;Taylor J;Buckner J;Parsons JK;Morris M;Tilburt JC
面对不确定的治疗效果，局限性前列腺癌的治疗面临着具有挑战性的权衡。这些选择最好在与患者的医疗团队共同决策的过程中权衡。少数族裔男性在前列腺癌结果方面存在差异，部分原因可能是由于在治疗选择过程中缺乏最佳沟通。决策辅助有助于共同决策，提高对治疗方案的了解，可以提高对治疗选择的满意度，并可能提高长期生活质量。这项研究将比较两种基于证据的决策辅助对患者知识和治疗一年后测量的生活质量的影响，对少数族裔男性进行了过度抽样。在专家咨询之前将提供一项决策援助，为患者进行治疗讨论做好准备。其他决策援助将在磋商期间进行管理，以促进透明、对偏好敏感和以证据为依据的审议。该研究将采用四臂、分块随机设计来测试与常规护理（第 4 组）相比，每种决策辅助单独（第 1 组和第 2 组）或组合（第 3 组）是否可以提高患者的知识和生活质量。该研究由美国国家癌症研究所社区肿瘤学研究计划 (NCORP) 资助，将在已证明有能力招募少数族裔参加泌尿肿瘤学试验的选定机构内部署。试验完成后，我们将 1) 测试两种循证决策辅助工具在增强患者对前列腺癌治疗选择的了解方面的有效性，以及 2) 估计决策辅助工具是否可以在初始治疗选择一年后改善患者的生活质量。 ClinicalTrials.gov：NCT03103321。试验注册日期（在 ClinicalTrials.gov 上）为 2017 年 4 月 6 日。
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.
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影响因子：
3.6
作者：
Brehaut, JC;O'Connor, AM;Feldman-Stewart, D
通讯作者：
Feldman-Stewart, D
影响因子：
2.3
作者：
Cohen, JH;Schoenbach, VJ;Godley, PA
通讯作者：
Godley, PA
影响因子：
2.1
作者：
Pitman, Max;Korets, Ruslan;McKiernan, James M.
通讯作者：
McKiernan, James M.
影响因子：
3
作者：
Pisu, Maria;Oliver, JoAnn S.;Richardson, Lisa C.
通讯作者：
Richardson, Lisa C.
影响因子：
9.7
作者：
Berwick, DM
通讯作者：
Berwick, DM