ArticleContemporary clinical trials2025
Engage: Protocol of a randomized controlled trial of a telehealth-delivered psychosocial intervention to decrease symptom interference in patients with advanced cancer.
Article in Contemporary clinical trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06555588 (Engage), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Engage: A Randomized Controlled Trial Testing the Efficacy of a Telehealth-Delivered Psychosocial Intervention to Decrease Symptom Interference in Patients With Advanced Cancer
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10 authors.
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Abstract
backgroundPain, 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/
designThis 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.
conclusionThis 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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