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Protocol for the promoting resilience in stress management (PRISM) intervention: a multi

泰然健康网
2025-04-12 10:05

Adolescents and young adults (AYAs) with cancer are at high risk of poor psychosocial outcomes, and evidence-based interventions designed to meet their psychosocial and communication needs are lacking. The main objective of this project is to test the efficacy of a new adaptation of the Promoting Resilience in Stress Management intervention for AYAs with Advanced Cancer (PRISM-AC). The PRISM-AC trial is a 2-arm, parallel, non-blinded, multisite, randomized controlled trial. 144 participants with advanced cancer will be enrolled and randomized to either usual, non-directive, supportive care without PRISM-AC (“control” arm) or with PRISM-AC (“experimental” arm). PRISM is a manualized, skills-based training program comprised of four 30–60 min, one-on-one sessions targeting AYA-endorsed resilience resources (stress-management, goal-setting, cognitive-reframing, and meaning-making). It also includes a facilitated family meeting and a fully equipped smartphone app. The current adaptation includes an embedded advance care planning module. English- or Spanish-speaking individuals 12–24 years old with advanced cancer (defined as progressive, recurrent, or refractory disease, or any diagnosis associated with < 50% survival) receiving care at 4 academic medical centers are eligible. Patients’ caregivers are also eligible to participate in this study if they are able to speak and read English or Spanish, and are cognitively and physically able to participate. Participants in all groups complete surveys querying patient-reported outcomes at the time of enrollment and 3-, 6-, 9-, and 12-months post-enrollment. The primary outcome of interest is patient-reported health-related quality of life (HRQOL) and secondary outcomes of interest include patient anxiety, depression, resilience, hope and symptom burden, parent/caregiver anxiety, depression and health-related quality of life, and family palliative care activation. We will conduct intention-to-treat analysis to compare the group means of primary and secondary outcomes between PRISM-AC arm and control arm with regression models. This study will provide methodologically rigorous data and evidence regarding a novel intervention to promote resilience and reduce distress among AYAs with advanced cancer. This research has the potential to offer a practical, skills-based curriculum designed to improve outcomes for this high-risk group. ClinicalTrials.gov Identifier NCT03668223, September 12, 2018.

中文翻译：

压力管理 (PRISM) 干预中促进弹性的方案：一项针对患有晚期癌症的青少年和年轻人的多中心随机对照试验

患有癌症的青少年和年轻成人 (AYAs) 面临心理社会后果不佳的高风险，并且缺乏旨在满足他们心理社会和沟通需求的循证干预措施。该项目的主要目标是测试针对患有晚期癌症的 AYAs (PRISM-AC) 的压力管理干预中促进复原力的新改编的有效性。PRISM-AC 试验是一项 2 臂、平行、非盲、多中心、随机对照试验。将招募 144 名患有晚期癌症的参与者，并随机分配到不使用 PRISM-AC（“控制”臂）或使用 PRISM-AC（“实验”臂）的常规、非指导性、支持性护理。PRISM 是一项基于技能的手动培训计划，由四个 30-60 分钟的一对一课程组成，针对 AYA 认可的弹性资源（压力管理、目标设定、认知重构和意义建构）。它还包括一个便利的家庭会议和一个设备齐全的智能手机应用程序。当前的改编包括一个嵌入式预先护理计划模块。在 4 个学术医疗中心接受治疗的 12-24 岁的讲英语或西班牙语的晚期癌症患者（定义为进行性、复发性或难治性疾病，或任何与生存率 < 50% 相关的诊断）符合条件。如果患者的护理人员能够说和读英语或西班牙语，并且在认知和身体上能够参与，他们也有资格参与这项研究。所有组的参与者都完成调查，询问患者在入组时和入组后 3、6、9 和 12 个月时报告的结果。感兴趣的主要结果是患者报告的与健康相关的生活质量 (HRQOL)，感兴趣的次要结果包括患者焦虑、抑郁、恢复力、希望和症状负担、父母/看护者焦虑、抑郁和与健康相关的生活质量，和家庭姑息治疗激活。我们将进行意向治疗分析，以使用回归模型比较 PRISM-AC 组和对照组之间主要和次要结果的组均值。这项研究将提供方法论上严格的数据和证据，说明一种新的干预措施，以促进患有晚期癌症的 AYA 的复原力和减少痛苦。这项研究有可能提供实用的、基于技能的课程，旨在改善这一高风险群体的结果。ClinicalTrials.gov 标识符 NCT03668223，2018 年 9 月 12 日。