Testing ENGAGE Telehealth Psychosocial Support to Reduce Symptoms in Adults With Advanced Breast, Prostate, Lung, or Colorectal Cancer
Led by Duke University · Updated on 2026-03-16
190
Participants Needed
1
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a new telehealth-delivered psychosocial intervention called ENGAGE for patients with Stage IV breast, prostate, lung, or colorectal cancer who experience moderate-to-severe symptom interference. This trial aims to test the effectiveness of ENGAGE in reducing symptoms like pain, fatigue, and distress that commonly affect quality of life in advanced cancer. The study compares ENGAGE to a Supportive Care intervention, focusing on patient-reported outcomes over time.
Participants will be randomly assigned to receive either ENGAGE or Supportive Care. Both interventions involve four telehealth sessions lasting 45 to 60 minutes each, delivered by trained therapists. ENGAGE combines cognitive behavioral therapy and acceptance and commitment therapy techniques to teach behavioral symptom management skills and encourage engagement in meaningful activities. Supportive Care provides education, support, and resources addressing common cancer-related concerns such as symptoms, body image, and financial issues.
During the study, participants will complete assessments at the start, 2 months, and 4 months to measure symptom interference and other outcomes using tools like the MD Anderson Symptom Inventory and PROMIS questionnaires. The research will track the impact on symptom severity, self-efficacy in managing symptoms, anxiety, depression, and quality of life. Data collection will also include feedback from patients, oncology providers, and clinic leaders to inform future implementation. The trial is expected to continue through November 2028.
CONDITIONS
Brief Title
Engage Psychosocial Intervention for Cancer Symptoms
Research Team
J
Joseph G Winger, PhD
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
ENGAGE (CBT + ACT tele‑health)
Supportive Care (education/support tele‑health)
What each intervention involves
Four manualized tele‑health sessions integrating cognitive behavioral therapy and acceptance and commitment therapy to train symptom management skills and support values‑based activity
Four manualized tele‑health sessions providing education, emotional support, and resources for living with advanced cancer symptoms
Role in trial
Investigational behavioral intervention arm
Active comparator behavioral supportive care arm
Purpose
To reduce symptom interference and enhance symptom management skills via CBT and ACT techniques
To provide general symptom‑relevant education, emotional support, and resources
How delivered
Delivered via four therapist‑led tele‑health sessions of 45‑60 minutes each
Delivered via four therapist‑led tele‑health sessions of 45‑60 minutes each
Broader evidence for ACT‑based interventions
Some systematic reviews and trials in advanced cancer suggest ACT‑based interventions may alleviate anxiety, depression, distress, fatigue and improve quality of life
General psychosocial interventions including supportive education may improve emotional functioning and communication in advanced cancer populations
Limitations
Evidence for ACT‑based interventions in advanced cancer is promising but involves small trials, and certainty remains low to moderate
Supportive care effectiveness varies with intervention type and delivery, and evidence specific to tele‑health education is limited
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Receiving cancer care at a Duke Cancer Network clinic or Duke Cancer Institute and living at least 60 miles from Duke in a rural county
Oncologist confirmed Stage IV breast, prostate, lung, or colorectal cancer
Moderate-to-severe pain, fatigue, or distress with a rating of 3 or higher out of 10 for at least two symptoms in the past 7 days
Average score of 3 or higher out of 10 on the MD Anderson Symptom Inventory Interference with Daily Living Scale in the past 7 days
Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
At least 18 years old
Ability to speak and read English
Hearing and vision sufficient to complete telehealth sessions
You will not qualify if you...
Significant cognitive impairment as noted in medical records or during telephone screening
Serious psychiatric conditions such as schizophrenia or suicidal intent that would make participation unsafe
Participation in cognitive-behavioral therapy or acceptance and commitment therapy for cancer symptom management within the last 6 months
Enrollment in hospice care at screening
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (telehealth or phone)
Outpatient Treatment
Duration - Approximately 4 to 6 weeks
Participants receive four telehealth sessions delivered by trained therapists focusing on either behavioral symptom management or education and support for cancer-related concerns.
4 telehealth sessions
Follow-up
Duration - Up to 4 months
Participants complete patient-reported outcome assessments to evaluate symptom interference and other secondary outcomes at 2 and 4 months after starting treatment.
Assessment visits at 2 months and 4 months (telehealth or remote)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Engage: Protocol of a randomized controlled trial of a telehealth-delivered psychosocial intervention to decrease symptom interference in patients with advanced cancer.