一项基于网络的积极情绪技能干预措施，用于增强青年癌症幸存者治疗后的心理健康（EMPOWER）：单臂可行性试验方案。
A Web-Based, Positive Emotion Skills Intervention for Enhancing Posttreatment Psychological Well-Being in Young Adult Cancer Survivors (EMPOWER): Protocol for a Single-Arm Feasibility Trial.
作者信息
Salsman John M, McLouth Laurie E, Cohn Michael, Tooze Janet A, Sorkin Mia, Moskowitz Judith T
机构信息
Department of Social Sciences and Health Policy, Wake Forest Baptist Comprehensive Cancer Center, Wake Forest School of Medicine, Winston Salem, NC, United States.
Department of Behavioral Science, Markey Cancer Center, University of Kentucky College of Medicine, Lexington, KY, United States.
出版信息
JMIR Res Protoc. 2020 May 28;9(5):e17078. doi: 10.2196/17078.
BACKGROUND
Adolescent and young adult cancer survivors (AYAs) experience clinically significant distress and have limited access to supportive care services. Interventions to enhance psychological well-being have improved positive affect and reduced depression in clinical and healthy populations but have not been routinely tested in AYAs.
OBJECTIVE
The aim of this protocol is to (1) test the feasibility and acceptability of a Web-based positive emotion skills intervention for posttreatment AYAs called Enhancing Management of Psychological Outcomes With Emotion Regulation (EMPOWER) and (2) examine proof of concept for reducing psychological distress and enhancing psychological well-being.
METHODS
The intervention development and testing are taking place in 3 phases. In phase 1, we adapted the content of an existing, Web-based positive emotion intervention so that it would be suitable for AYAs. EMPOWER targets 8 skills (noticing positive events, capitalizing, gratitude, mindfulness, positive reappraisal, goal setting, personal strengths, and acts of kindness) and is delivered remotely as a 5-week, Web-based intervention. Phase 2 consisted of a pilot test of EMPOWER in a single-arm trial to evaluate feasibility, acceptability, retention, and adherence and to collect data on psychosocial outcomes for proof of concept. In phase 3, we are refining study procedures and conducting a second pilot test.
RESULTS
The project was part of a career development award. Pilot work began in June 2015, and data collection was completed in March 2019. The analysis is ongoing, and results will be submitted for publication by May 2020.
CONCLUSIONS
If this intervention proves feasible and acceptable, EMPOWER will be primed for a subsequent large, multisite randomized controlled trial. As a scalable intervention, it will be ideally suited for AYA survivors who would otherwise not have access to supportive care interventions to help manage posttreatment distress and enhance well-being.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02832154, https://clinicaltrials.gov/ct2/show/NCT02832154.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17078.
背景
青少年及青年癌症幸存者（AYAs）经历着临床上显著的痛苦，且获得支持性护理服务的机会有限。旨在增强心理健康的干预措施已在临床及健康人群中改善了积极情绪并减轻了抑郁，但尚未在AYAs中进行常规测试。
目的
本方案的目的是：（1）测试一种名为“通过情绪调节增强心理结果管理”（EMPOWER）的基于网络的积极情绪技能干预措施对治疗后的AYAs的可行性和可接受性；（2）检验减少心理痛苦和增强心理健康的概念验证。
方法
干预措施的开发和测试分三个阶段进行。在第一阶段，我们调整了现有的基于网络的积极情绪干预措施的内容，使其适合AYAs。EMPOWER针对8种技能（注意积极事件、充分利用、感恩、正念、积极重新评价、目标设定、个人优势和善意行为），作为一项为期5周的基于网络的干预措施进行远程提供。第二阶段包括在一项单臂试验中对EMPOWER进行试点测试，以评估可行性、可接受性、保留率和依从性，并收集心理社会结果数据以进行概念验证。在第三阶段，我们正在完善研究程序并进行第二次试点测试。
结果
该项目是职业发展奖的一部分。试点工作于2015年6月开始，数据收集于2019年3月完成。分析正在进行中，结果将于2020年5月前提交发表。
结论
如果该干预措施被证明是可行和可接受的，EMPOWER将为后续大规模、多地点的随机对照试验做好准备。作为一种可扩展的干预措施，它将非常适合那些否则无法获得支持性护理干预措施以帮助管理治疗后痛苦并增强幸福感的AYA幸存者。
试验注册
ClinicalTrials.gov NCT02832154，https://clinicaltrials.gov/ct2/show/NCT02832154。
国际注册报告识别码（IRRID）：DERR1-10.2196/17078。
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