Decision Navigation for Advanced Prostate Cancer Treatment Options using mHealth

使用移动医疗为晚期前列腺癌治疗方案进行决策导航

• 批准号: 9260554
• 负责人: RANDY ALLEN JONES
• 金额: $ 49.17万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-02-06 至 2020-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9260554
• 关键词: Academy; Address; Adherence; Advanced Malignant Neoplasm; Affect; Affordable Care Act; African American; Age-Years; Behavioral; Cancer Center; Cancer Etiology; Cancer Patient; Caregivers; Caring; Caucasians; Cessation of life; Cognitive; Communication; Communities; Complex; Comprehensive Cancer Center; Conflict (Psychology); Control Groups; Data; Data Analyses; Decision Aid; Decision Making; Disease; Disease Progression; Education; Emotional; Event; Extended Family; Face; Fibrinogen; Goals; Health; Health Personnel; Healthcare; Individual; Information Technology; Institute of Medicine (U.S.); Intervention; Interview; Linear Models; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Medicine; Methods; Minority; Modeling; Nature; Oncologic Nursing; Oncology Nurse; Oral; Outcome; Outcome Measure; Pamphlets; Participant; Patient Self-Report; Patient-Focused Outcomes; Patients; Perception; Persons; Process; Provider; Proxy; Qualitative Evaluations; Quality of life; Race; Randomized; Randomized Controlled Trials; Recommendation; Registered nurse; Regrets; Research Personnel; Role; Self Management; Site; Stratification; Subgroup; Suggestion; Technology; Testing; Time; Training; Uncertainty; Underserved Population; United States National Institutes of Health; Universities; Virginia; anticancer treatment; base; cancer care; cancer diagnosis; cancer therapy; design; experience; group intervention; improved; improved outcome; innovation; mHealth; men; outcome forecast; population based; preference; primary outcome; programs; psychosocial; shared decision making; skills; theories; treatment as usual; treatment choice; treatment effect; uptake

PROJECT SUMMARY. Many patients with advanced prostate cancer along with their decision partners/ proxies (DPP) struggle with complex treatment decisions, such as when to start, change, or stop cancer directed treatment. Despite the utility of decision aids (DAs) to address decisional conflict, little is known about treatment decision-making for advanced cancers. The study's primary aim is to test the effects of a theory- based mHealth DA (CHAMPION) administered by Registered Nurse (RN)-Community Patient Navigator (CPN) teams to advanced prostate cancer patients and decision partners/proxies on the following outcomes: less decisional conflict/uncertainty, higher psychosocial quality of life domain (HRQL-PSY), and less regret at the time of making an anti-cancer treatment decision. The secondary aim is to evaluate the CPN role in delivery of the mHealth DA (CHAMPION) from the patients' and decision partners/proxies' perspective. Preliminary estimates of treatment effects by race to see if the data support a larger effect among African Americans versus Others in the primary and secondary aims will also be explored. This mixed-methods population-based randomized controlled trial will gather data from 158 patient/DPP pairs at three sites: University of Virginia Emily Couric Cancer Center, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, and Virginia Commonwealth University Massey Cancer Center. The pretest/posttest design will measure a time period that includes three single-event decisions over the course of their cancer-directed treatment; and a qualitative retrospective design will allow exploring the experiences of both patients and their DPPs separately in an interview at the completion of the study. Stratification by race (African-American and Caucasian/Other) and decision point (starting vs. changing vs. stopping anticancer treatment) will be used. There will be two groups: the control (enhanced usual care [EUC]) group and the decision intervention (DI) group. The DI group will receive an interactive 7-component cognitive-behavioral skills mHealth program (DA) with a RN-CPN team, primarily focusing on decision-making during cancer treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with DI. The primary outcome measures are 1) decisional conflict (uncertainty), 2) decisional regret, 3) HRQL-PSY, and 4) decision-making participation preference. Generalized linear models will be used for data analysis for the quantitative component, and qualitative evaluation of the intervention will be conducted to capture each pair's experience of the CHAMPION intervention. This innovative mHealth DA delivered by a CPN is expected to increase acceptability and the uptake of both the DA and the technology components. This addresses several NIH/NINR innovative questions, through the use of information technology to promote health-related decision-making for providers and patients, examining patient outcomes for improvement in healthcare, as well as to engage and support individuals such as extended family, lay coaches, etc. to augment provider care and recommendations.

项目总结。许多晚期前列腺癌患者和他们的决定伙伴/ 代理人(DPP)在复杂的治疗决策中苦苦挣扎，例如何时开始、改变或停止癌症 定向治疗。尽管决策辅助工具(DA)可用于解决决策冲突，但人们对此知之甚少 晚期癌症的治疗决策。这项研究的主要目的是测试一种理论的效果-- 注册护士(RN)-社区患者导航员(CPN)管理的基于mHealth DA(冠军) 团队对晚期前列腺癌患者和决定合作伙伴/代理人的以下结果：更少 决策冲突/不确定性，较高的心理社会生活质量(HRQL-PSY)，以及较少的后悔 是时候做出抗癌治疗决定了。第二个目标是评估CPN在交付 从患者和决策伙伴/代理人的角度来看，mHealth DA(冠军)。初步 按种族对治疗效果的估计，看看数据是否支持在非裔美国人中产生更大的效果 还将探讨在主要和次要目标上与其他目标的区别。这种混合方法是以总体为基础的 随机对照试验将从三个地点的158名患者/DPP对收集数据：弗吉尼亚大学 艾米丽·库里克癌症中心，约翰·霍普金斯大学西德尼·基梅尔综合癌症中心， 和弗吉尼亚联邦大学梅西癌症中心。前测/后测设计将测量 时间段，包括在其癌症指导的治疗过程中的三个单一事件决定；以及 定性回顾设计将允许分别探讨患者和他们的DPP的经历 在研究结束时接受采访时。按种族分层(非裔美国人和高加索人/其他人) 和决策点(开始与改变抗癌治疗与停止抗癌治疗)将被使用。会有两个人 分组：对照组(强化日常护理[EUC])组和决策干预组(DI)。DI组 将与RN-CPN团队一起接受交互式7项认知行为技能mHealth计划(DA)， 主要关注癌症治疗过程中的决策。将对所有人使用自我报告措施 参与者除了调查与DI的访谈录音外。主要结果衡量标准为1) 决策冲突(不确定性)，2)决策后悔，3)HRQL-PSY，4)决策参与 偏好。将使用广义线性模型对定量组成部分进行数据分析，以及 将对干预进行定性评估，以获取每对冠军的经验 干预。由CPN提供的这一创新的mHealth DA预计将提高可接受性，并 对发展议程和技术组成部分的理解。这解决了NIH/NINR的几个创新 问题，通过使用信息技术促进提供者作出与健康有关的决策 和患者，检查患者的结果以改善医疗保健，以及参与和支持 个人，如大家庭，业馀教练等，以加强提供者的关怀和建议。