Engage: Protocol of a randomized controlled trial of a telehealth-delivered psychosocial intervention to decrease symptom interference in patients with advanced cancer

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-08-18 DOI:10.1016/j.cct.2025.108053

Joseph G. Winger , Sarah A. Kelleher , Justin A. Yu , Jessica E. Ma , Catherine M. Majestic , Elizabeth B. Martinson , Maren K. Olsen , Reginald Lerebours , Linda M. Sutton , Tamara J. Somers

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引用次数: 0

Abstract

Background

Pain, fatigue, and distress are highly prevalent co-occurring symptoms in patients with stage IV cancer. Emerging evidence suggests these patients may benefit from Acceptance and Commitment Therapy (ACT), a Cognitive-Behavioral Therapy (CBT) approach that emphasizes acceptance, mindfulness, and engagement in value-guided activity. Our team developed and successfully pilot tested Engage, a psychosocial intervention integrating CBT skills (e.g., activity pacing) and ACT skills (e.g., mindfulness), with the goal of decreasing symptom interference and improving quality of life (QoL).

Method/design

This paper describes the protocol of a randomized controlled trial to evaluate Engage's efficacy for reducing symptom interference in patients receiving cancer care in medically underserved areas. We aim to enroll 190 patients with stage IV breast, prostate, lung, or colorectal cancer. Participants will be randomized 1:1 to Engage or Supportive Care control. Both conditions will be delivered by therapists over four, 45-min telehealth sessions. Aim 1 is to determine Engage's efficacy for reducing symptom interference (primary outcome) at 2 months (primary endpoint). Aim 2 is to determine Engage's efficacy for improving secondary outcomes (i.e., self-efficacy for symptom management, acceptance, mindfulness, valued activity engagement, symptom severity, and QoL) at 2 months. Aim 3 is to test the maintenance of Engage's effects at 4 months. An exploratory aim seeks insights for future implementation efforts.

Conclusion

This trial is one of the first to evaluate the efficacy of an ACT-based intervention for patients with stage IV cancers, yielding important information about ways to reduce suffering in this patient population.

Registered on ClinicalTrials.gov on August 13, 2024, Identifier: NCT06555588

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参与：远程医疗提供的心理社会干预减少晚期癌症患者症状干扰的随机对照试验方案

背景：疼痛、疲劳和焦虑是IV期癌症患者中非常普遍的共同症状。新出现的证据表明，这些患者可能受益于接受和承诺治疗（ACT），这是一种认知行为治疗（CBT）方法，强调接受、正念和参与价值导向的活动。我们的团队开发了Engage，并成功进行了试点测试，这是一种整合CBT技能（例如，活动节奏）和ACT技能（例如，正念）的社会心理干预，旨在减少症状干扰，提高生活质量（QoL）。方法/设计本文描述了一项随机对照试验的方案，以评估Engage在医疗服务不足地区接受癌症治疗的患者中减少症状干扰的疗效。我们的目标是招募190名IV期乳腺癌、前列腺癌、肺癌或结直肠癌患者。参与者将以1:1的比例随机分配到参与治疗组或支持治疗组。这两种情况都将由治疗师在四次45分钟的远程医疗会议上提供。目的1是确定Engage在2个月（主要终点）时减少症状干扰（主要结局）的疗效。目的2是确定Engage在2个月时改善次要结果（即症状管理的自我效能、接受度、正念、有价值的活动参与、症状严重程度和生活质量）的功效。目标3是测试Engage的效果在4个月后的维持情况。探索性目标寻求对未来实施工作的见解。该试验是第一个评估基于act的干预对IV期癌症患者疗效的试验之一，为减少这一患者群体的痛苦提供了重要信息。于2024年8月13日在ClinicalTrials.gov注册，标识符：NCT06555588

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.