Psychosocial intervention for managing symptoms in advanced cancer patients
Engage: A Randomized Controlled Trial Testing the Efficacy of a Telehealth-Delivered Psychosocial Intervention to Decrease Symptom Interference in Patients With Advanced Cancer
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06555588 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with Stage IV breast, prostate, lung, or colorectal cancer experiencing moderate-to-severe symptom interference.
Not a fit: Patients with significant cognitive impairments or serious psychiatric conditions may not benefit from this intervention.
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 performed: Other studies have shown promise in using psychosocial interventions for symptom management in cancer patients, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Durham, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.