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

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-06-12 DOI:10.1016/j.conctc.2025.101506

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

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引用次数: 0

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.

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一项随机试验的研究方案，在癌症幸存者和转移者的护理人员中建立弹性

癌症幸存者的照顾者经历着长期的压力，增加了情绪和身体健康的风险。许多照护者报告心理社会需求未得到满足，应对策略不适应，导致照护者负担加重，生活质量受损。现有的干预措施主要针对积极治疗期间或与临终关怀相关的护理人员的需求，很少为护理人员提供有针对性的资源，以应对积极治疗后生存的挑战-无论是那些支持幸存者（已完成治愈性治疗的癌症幸存者）还是幸存者（患有转移性疾病的患者）。目的：本单点随机试验“一起向前”（ForTe）旨在确定压力管理和弹性训练的可行性（如入组、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）以及对弹性和医疗保健利用的初步影响：放松反应弹性计划（SMART-3RP）与强化常规护理(EUC；转介到CanCare.org护理人员和患者虚拟支持小组)。（临床试验ID: NCT05702723）方法采用多模式招募方法，包括主动和被动方法，以确定本研究的潜在双性恋。二人组（癌症幸存者和护理者）将按1:1随机分为SMART-3RP组或EUC组。被随机分配到SMART-3RP的二人组将分别但同时参加9个针对幸存者或护理人员的小组会议。这项研究是由美国国家癌症研究所资助的。研究程序由丹娜-法伯哈佛癌症中心机构审查委员会批准。研究程序完整；数据分析正在进行中。

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 Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles 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 a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.