Seattle Children's Research Institute, Seattle, WA, USA.
University of Denver, Denver, CO, USA.
BMC Palliat Care. 2023 May 16;22(1):60. doi: 10.1186/s12904-023-01179-4.
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).
METHODS/DESIGN: 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.
患有癌症的青少年和年轻人（AYAs）面临着心理健康不良的高风险，缺乏针对其心理社会和沟通需求的循证干预措施。本项目的主要目标是测试新改编的《癌症晚期青少年压力管理促进韧性（PRISM-AC）》的疗效。
方法/设计：PRISM-AC 试验是一项 2 臂、平行、非盲、多地点、随机对照试验。将招募 144 名患有晚期癌症的参与者，并将其随机分为常规、非直接、无 PRISM-AC 的支持性护理（“对照”组）或 PRISM-AC（“实验”组）。PRISM 是一种基于技能的手册化培训计划，包括四个 30-60 分钟的一对一课程，针对 AYA 认可的韧性资源（压力管理、目标设定、认知重述和意义建构）。它还包括一个促进的家庭会议和一个功能齐全的智能手机应用程序。目前的改编包括一个嵌入式的预先护理计划模块。符合条件的参与者为在 4 个学术医疗中心接受治疗的 12-24 岁的英语或西班牙语晚期癌症（定义为进行性、复发性或难治性疾病，或任何与 <50%生存率相关的诊断）。如果患者的照顾者能够说和阅读英语或西班牙语，并且能够在认知和身体上参与，则他们也有资格参加这项研究。所有组别的参与者在入组时和入组后 3、6、9 和 12 个月完成调查，询问患者报告的结果。主要研究结果为患者报告的健康相关生活质量（HRQOL），次要研究结果包括患者焦虑、抑郁、韧性、希望和症状负担、父母/照顾者焦虑、抑郁和健康相关生活质量，以及家庭姑息治疗激活。我们将进行意向治疗分析，比较 PRISM-AC 臂和对照组之间的主要和次要结果的组间均值，使用回归模型。
本研究将提供关于针对晚期癌症 AYA 促进韧性和减轻痛苦的新干预措施的严格方法学数据和证据。这项研究有可能提供一种实用的、基于技能的课程，旨在改善这一高危人群的结局。
ClinicalTrials.gov 标识符 NCT03668223，2018 年 9 月 12 日。
