Metastatic prostate cancer remains a lethal malignancy that warrants novel supportive interventions for patients and their decision partners and proxies. Decision aids have been applied primarily to patients with localized disease, with minimal inclusion of patients with advanced prostate cancer and their decision partners. The use of a community patient navigator (CPN) has been shown to have a positive supportive role in health care, particularly with individuals from minority populations. Research is needed to evaluate decision support interventions tailored to the needs of advanced prostate cancer patients and their decision partners in diverse populations. Guided by Janis and Mann’s Conflict Model of Decision Making, the Cancer Health Aid to Manage Preferences and Improve Outcomes through Navigation (CHAMPION) is a randomized controlled trial to assess the feasibility and acceptability of a mobile health (mHealth), CPN-administered decision support intervention designed to facilitate communication between patients, their decision partners, and the healthcare team. Adult prostate cancer patients and their decision partners at three mid-Atlantic hospitals in the USA were randomized to receive enhanced usual care or the decision intervention. The CHAMPION intervention includes a theory-based decision-making process tutorial, immediate and health-related quality of life graphical summaries over time (using mHealth), values clarification via a balance sheet procedure with the CPN support during difficult decisions, and facilitated discussions with providers to enhance informed, shared decision-making. The CHAMPION intervention is designed to leverage dynamic resources, such as CPN teams, mHealth technology, and theory-based information, to support decision-making for advanced prostate cancer patients and their decision partners. This intervention is intended to engage decision partners in addition to patients and represents a novel, sustainable, and scalable way to build on individual and community strengths. Patients from minority populations, in particular, may face unique challenges during clinical communication. CHAMPION emphasizes the inclusion of decision partners and CPNs as facilitators to help address these barriers to care. Thus, the CHAMPION intervention has the potential to positively impact patient and decision partner well-being by reducing decisional conflict and decision regret related to complex, treatment-based decisions, and to reduce cancer health disparities. Trial registration ClinicalTrials.gov NCT03327103 . Registered on 31 October 2017—retrospectively registered. World Health Organization Trial Registration Data Set included in Supplementary Materials.

中文翻译：

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采用移动健康决策辅助工具来改善晚期前列腺癌患者及其决策伙伴/代理人的决策：CHAMPION 随机对照试验研究设计

转移性前列腺癌仍然是一种致命的恶性肿瘤，需要为患者及其决策伙伴和代理人提供新的支持性干预措施。决策辅助工具主要应用于患有局部疾病的患者，极少包括晚期前列腺癌患者及其决策伙伴。事实证明，社区患者导航器 (CPN) 的使用对医疗保健具有积极的支持作用，特别是对于少数族裔人群。需要进行研究来评估针对不同人群的晚期前列腺癌患者及其决策伙伴的需求而定制的决策支持干预措施。在 Janis 和 Mann 决策冲突模型的指导下，通过导航管理偏好和改善结果的癌症健康援助 (CHAMPION) 是一项随机对照试验，旨在评估移动医疗 (mHealth)、CPN 管理的决策支持的可行性和可接受性旨在促进患者、其决策伙伴和医疗团队之间沟通的干预措施。美国大西洋中部三家医院的成年前列腺癌患者及其决策伙伴被随机分配接受强化常规护理或决策干预。CHAMPION 干预措施包括基于理论的决策过程教程、随时间变化的即时且与健康相关的生活质量图形摘要（使用移动医疗）、在困难决策期间在 CPN 支持下通过资产负债表程序澄清价值观，并促进与提供者加强知情、共同决策。CHAMPION 干预旨在利用动态资源（例如 CPN 团队、移动医疗技术和基于理论的信息）来支持晚期前列腺癌患者及其决策伙伴的决策。这种干预措施旨在让除患者之外的决策合作伙伴参与进来，并代表了一种新颖、可持续且可扩展的方式来发挥个人和社区的优势。特别是来自少数群体的患者在临床沟通过程中可能面临独特的挑战。CHAMPION 强调将决策合作伙伴和 CPN 作为促进者，帮助解决这些护理障碍。因此，CHAMPION 干预有可能通过减少与复杂的、基于治疗的决策相关的决策冲突和决策后悔，对患者和决策伙伴的福祉产生积极影响，并减少癌症健康差异。试验注册 ClinicalTrials.gov NCT03327103。2017年10月31日注册——追溯注册。世界卫生组织试验注册数据集包含在补充材料中。