Psychosocial intervention for managing symptoms in advanced cancer patients
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
Run by Duke University · NCT06555588 · Data updated 2026-11-12
This study is testing a new telehealth program called ENGAGE to see if it can help people with advanced cancer manage their symptoms and improve their quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 190 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | June 11, 2025 |
| Main results expected | September 2028 |
| Study ends | November 2028 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT06555588 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults with Stage IV breast, prostate, lung, or colorectal cancer experiencing moderate-to-severe symptom interference.
✕Probably not a fit
Patients with significant cognitive impairments or serious psychiatric conditions may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of a new telehealth psychosocial intervention called ENGAGE for patients with Stage IV breast, prostate, lung, or colorectal cancer. Participants will be randomly assigned to receive either the ENGAGE intervention or supportive care. The study aims to reduce symptom interference and improve quality of life by addressing pain, fatigue, and distress through a structured program. Patient-reported outcomes will be measured at baseline, 2 months, and 4 months to assess the intervention's efficacy and sustainability.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life for patients suffering from advanced cancer symptoms.
How similar studies have gone: Other studies have shown promise in using psychosocial interventions for symptom management in cancer patients, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
Duke Cancer Network
Durham, North Carolina, United States Recruiting
Study contacts
- Study coordinator: Joseph G Winger, PhD
- Email: joseph.winger@duke.edu
- Phone: 919-416-7506
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.