ENGAGE Psychosocial Intervention for Advanced Cancer Symptoms

This study is testing a new support program called ENGAGE for people with advanced breast, prostate, lung, or colorectal cancer. ENGAGE is a behavioral therapy delivered through four telehealth (video or phone) sessions by trained therapists. It combines Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) to help manage symptoms like pain, fatigue, and distress. You would be randomly assigned to either receive ENGAGE or a Supportive Care program, which also involves four telehealth sessions providing education and resources. The main goal is to see if ENGAGE can reduce how much these symptoms interfere with your daily life after two months. To join, you need to be receiving cancer care at a Duke Cancer Network clinic or Duke Cancer Institute, have Stage IV cancer, and experience moderate to severe pain, fatigue, or distress.

Study design
This is an interventional study with 190 planned participants. Participants will be randomly assigned to receive either the ENGAGE intervention or a Supportive Care intervention.
What's involved
You would participate in four 45-60 minute telehealth sessions. Your symptoms and daily life interference will be assessed at the start, at 2 months, and at 4 months.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms and daily life interference will be assessed at 2 months and 4 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06555588

Engage Psychosocial Intervention for Cancer Symptoms

Recruiting
NAAges 18+InterventionalSupportive care
Duke University
~190 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:ENGAGESupportive Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale
Measured over 2 months
Advanced Breast Cancer
Advanced Prostate Cancer
Advanced Lung Cancer
Advanced Colorectal Carcinoma
Advanced Colorectal Adenocarcinoma
1 sites across 1 states
North Carolina1

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Receiving cancer care at 1) a Duke Cancer Network (DCN) clinic; or 2) the Duke Cancer Institute (DCI) and live in a rural county at least 60 miles from Duke
Oncologist confirmed Stage IV breast, prostate, lung, or colorectal cancer
Worst pain, fatigue, or distress rated at \>/= 3 out of 10 in the past 7 days for at least 2 symptoms
MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale average score of \>/= 3 out of 10 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 that allows for successful completion of telehealth sessions

Exclusion

Significant cognitive impairment indicated in medical chart or during telephone screening on a mental status questionnaire
Serious psychiatric condition (e.g., schizophrenia, suicidal intent) that would contraindicate safe study participation
Participation in the last 6 months in Cognitive-Behavioral Therapy or Acceptance and Commitment Therapy for cancer symptom management
Enrollment in hospice at screening
  • MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale2 months

    This measure assesses the degree to which, over the past 7 days, symptoms of pain, fatigue, and/or distress have interfered with patients' general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life. Items are scored from 0 = "Did not interfere" to 10 = "Interfered completely," and averaged for a composite score.