RecruitingNot ApplicableNCT06555588

Engage Psychosocial Intervention for Cancer Symptoms

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

Sponsor

Duke University

Enrollment

190 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Breast Cancer Advanced Prostate Cancer Advanced Lung Cancer Advanced Colorectal Carcinoma Advanced Colorectal Adenocarcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a telephone and video-based counseling program called "Engage" that aims to help people with advanced cancer manage symptoms like pain, fatigue, and emotional distress. It is designed for patients who live far from their cancer center or in rural areas. **You may be eligible if...** - You have been diagnosed with Stage IV breast, prostate, lung, or colorectal cancer - You are receiving cancer care at a Duke Cancer Network clinic or Duke Cancer Institute and live in a rural county at least 60 miles away - You rate at least 2 symptoms (pain, fatigue, or distress) as 3 or higher out of 10 - You are 18 or older and can speak and read English - You can hear and see well enough to participate in video/phone sessions **You may NOT be eligible if...** - You have significant cognitive impairment - You have a serious psychiatric condition like schizophrenia or active suicidal intent - You have participated in Cognitive Behavioral Therapy or Acceptance and Commitment Therapy for cancer symptoms in the last 6 months - You are currently enrolled in hospice care Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALENGAGE

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.

BEHAVIORALSupportive 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).