The effectiveness of a psychological intervention targeting bereaved caregivers of cancer patients: Study protocol for the EMPOWER-Cancer-grief RCT

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-05-14 DOI:10.1016/j.cct.2025.107949

Loukas Christodoulou , Panagiotis Parpottas , Paris Vogazianos , Holly G. Prigerson , Wendy Lichtenthal , Eleni Petkari

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引用次数: 0

Abstract

Background

Informal caregivers (e.g., family members) of cancer patients experience significant demands in time, energy and mental resources. While several interventions target cancer caregivers, most focus on distress, overlooking positive outcomes (e.g. resilience and post-traumatic growth). This study aims to test the feasibility, acceptability and effectiveness of an adapted version of the EMPOWER (Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience) intervention for protecting Cypriot bereaved cancer caregivers against distress and promoting positive outcomes.

Methods

The study will follow an open trial and a posterior Randomized Controlled Trial (RCT) design whereby study participants will be randomized 1:1 to either the EMPOWER intervention or the control group arms. Eligible participants will be adult caregivers who experienced a cancer-related loss within the last 18 months and are at risk of prolonged grief disorder (PGD) (i.e., have high scores on the PG-13-R and TRIG). EMPOWER is a blended intervention combining evidence-based cognitive-behavioural approaches, psychoeducation, acceptance-based principles and meaning-centred grief therapy techniques. The adapted intervention (EMPOWER-Cancer-Grief) will consist of individual weekly face-to-face sessions delivered over a six-week period. Control group participants will attend a 1.5-h psycho-educational session. Outcomes will include depression and anxiety symptoms, PGD risk, resilience, post-traumatic growth and experiential avoidance. Data will be collected at baseline, post-treatment and one- and three-month's follow-ups post intervention.

Discussion

Findings will provide insight into the intervention effectiveness for decreasing distress and increasing positive outcomes in cancer caregivers, and its feasibility and acceptability with Cypriot sample.

Trial Registration: ISRCTN12141154.

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针对癌症患者家属照顾者的心理干预的有效性：EMPOWER-Cancer-grief随机对照试验的研究方案

背景：癌症患者的非正式照顾者（如家庭成员）在时间、精力和精神资源方面都有很大的需求。虽然有一些干预措施针对癌症护理人员，但大多数干预措施关注的是痛苦，而忽视了积极的结果（例如复原力和创伤后成长）。本研究旨在测试的可行性，可接受性和有效性的改编版本授权（加强和动员健康和情绪弹性的潜力）干预保护塞浦路斯失去亲人的癌症照顾者免受痛苦和促进积极的结果。方法：该研究将遵循开放试验和后验随机对照试验（RCT）设计，其中研究参与者将以1:1的比例随机分配到EMPOWER干预组或对照组。符合条件的参与者将是在过去18 个月内经历过癌症相关损失的成年护理人员，并且有长期悲伤障碍（PGD）的风险（即PG-13-R和TRIG得分较高）。EMPOWER是一种混合干预，结合了基于证据的认知行为方法、心理教育、基于接受的原则和以意义为中心的悲伤治疗技术。适应性干预（EMPOWER-Cancer-Grief）将包括为期六周的每周面对面的个人会议。对照组参与者参加1.5小时的心理教育课程。结果将包括抑郁和焦虑症状、PGD风险、复原力、创伤后成长和经验回避。数据将在基线、治疗后以及干预后1个月和3个月的随访时收集。讨论：研究结果将提供洞察干预的有效性，以减少痛苦和增加癌症护理人员的积极结果，其可行性和可接受性与塞浦路斯的样本。试验注册：ISRCTN12141154。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.