Engage Psychosocial Intervention for Cancer Symptoms
Recruiting now · Not applicable
Conditions studied: Advanced Breast Cancer, Advanced Prostate Cancer, Advanced Lung Cancer, Advanced Colorectal Carcinoma, Advanced Colorectal Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT06555588
- Run by
- Duke University
- People needed
- 190
- Starts
- 2025-06-11
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2026-03-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Duke Cancer Network — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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