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一项针对癌症幸存者和转移癌幸存者照料者建立复原力的试点随机试验的研究方案。

Study protocol for a pilot randomized trial building resiliency among caregivers of cancer curvivors and metavivors.

作者信息

Goshe Brett M, Barata Anna, Finkelstein-Fox Lucy, Cloutier Joanna, Farnam Emelia, Holmbeck Katie, Waldron Elizabeth, Perez Giselle K, Malloy Laura, Miranda Isabelle, Hager Wren, Horick Nora, El-Jawahri Areej, Park Elyse

机构信息

Massachusetts General Hospital, Boston, MA, USA.

Havard Medical School Boston, MA, USA.

出版信息

Contemp Clin Trials Commun. 2025 Jun 19;46:101506. doi: 10.1016/j.conctc.2025.101506. eCollection 2025 Aug.

Abstract

BACKGROUND

Caregivers of cancer survivors experience chronic stress, increasing emotional and physical health risks. Many caregivers report unmet psychosocial needs and maladaptive coping strategies, resulting in high caregiver burden and impaired quality of life. Existing interventions primarily address caregiver needs during active treatment or in relation to end-of-life care, with few providing targeted resources for caregivers coping with the challenges of post-active treatment survivorship - either for those supporting curvivors (cancer survivors who have completed curative therapy) or metavivors (patients living with metastatic disease).

OBJECTIVE

This single-site pilot randomized trial, Forward Together (ForTe), aims to determine the feasibility (e.g., enrollment, survey completion, and group attendance rates), acceptability (e.g., program satisfaction and quality rating), and preliminary effects on resilience and healthcare utilization of the Stress Management and Resiliency Training: The Relaxation Response Resiliency Program (SMART-3RP) compared to Enhanced Usual Care (EUC; referral to CanCare.org caregiver and patient virtual support groups). (Clinical Trials ID: NCT05702723).

METHODS

A multimodal recruitment approach, including both proactive and reactive methods, will be used to identify potential dyads for this study. Dyads (cancer survivor and caregiver) will be randomized 1:1 to SMART-3RP or EUC. Dyads randomized to the SMART-3RP will participate separately but simultaneously in 9 survivor- or caregiver-specific group sessions.

RESULTS

This study is funded by the National Cancer Institute. Study procedures were approved by the Dana-Farber Harvard Cancer Center Institutional Review Board. Study procedures are complete; data analysis is ongoing.

摘要

背景

癌症幸存者的照顾者经历着慢性压力,增加了情绪和身体健康风险。许多照顾者报告心理社会需求未得到满足以及应对策略不当,导致照顾者负担沉重且生活质量受损。现有干预措施主要关注积极治疗期间或临终关怀阶段照顾者的需求,很少为应对积极治疗后幸存者阶段挑战的照顾者提供有针对性的资源——无论是对于那些支持治愈性幸存者(完成根治性治疗的癌症幸存者)还是转移性幸存者(患有转移性疾病的患者)。

目的

这项单中心试点随机试验“携手共进(ForTe)”旨在确定压力管理与恢复力训练:放松反应恢复力计划(SMART - 3RP)相较于强化常规护理(EUC;转介至CanCare.org照顾者和患者虚拟支持小组)的可行性(如招募、调查完成率和小组出勤率)、可接受性(如项目满意度和质量评级)以及对恢复力和医疗保健利用的初步影响。(临床试验标识:NCT05702723)。

方法

将采用多模式招募方法,包括主动和被动方法,来识别本研究的潜在配对对象。配对对象(癌症幸存者和照顾者)将按1:1随机分配至SMART - 3RP或EUC。随机分配至SMART - 3RP的配对对象将分别但同时参加9次针对幸存者或照顾者的特定小组会议。

结果

本研究由美国国立癌症研究所资助。研究程序已获得达纳 - 法伯哈佛癌症中心机构审查委员会的批准。研究程序已完成;数据分析正在进行中。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e2b6/12214282/aac95345708f/gr1.jpg

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