NCT06555588Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 190 (estimated)
- First submitted
- 13 Aug 2024
- Start date
- 11 Jun 2025
- Primary completion date
- Sept 2028
- Lead sponsor
- Duke University
- NCT number
- NCT06555588
What you commit to
- Study type: Interventional
- Planned participants: 190
- From 11 Jun 2025 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Enrollment in hospice at screening
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke Cancer Network Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.