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RECRUITING
NCT06555588
NA

Engage Psychosocial Intervention for Cancer Symptoms

Sponsor: Duke University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test the efficacy a new psychosocial symptom management intervention called ENGAGE for patients with Stage IV breast, prostate, lung, or colorectal cancer. Participants will be randomized to ENGAGE or a Supportive Care intervention. Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months.

Official title: Engage: A Randomized Controlled Trial Testing the Efficacy of a Telehealth-Delivered Psychosocial Intervention to Decrease Symptom Interference in Patients With Advanced Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

190

Start Date

2025-06-11

Completion Date

2028-11

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

BEHAVIORAL

ENGAGE

This intervention is delivered by trained therapists over four, 45-60 minute, manualized telehealth sessions. The session content is based on an integration of Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) approaches for managing symptoms of pain, fatigue, and distress. Participants are trained in behavioral symptom management skills (e.g., activity pacing, mindfulness) with an emphasis on engaging in highly valued activities.

BEHAVIORAL

Supportive Care

This intervention is delivered by trained therapists over four, 45-60 minute, manualized telehealth sessions. The session content is designed to provide participants with education, support, and resources for a range of issues relevant to those with advanced cancer (e.g., education on symptoms, body image concerns, and financial concerns).

Locations (1)

Duke Cancer Network

Durham, North Carolina, United States