Status:
RECRUITING
Engage Psychosocial Intervention for Cancer Symptoms
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Advanced Breast Cancer
Advanced Prostate Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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. Partic...
Detailed Description
Pain, fatigue, and distress are highly prevalent, co-occurring, and interfering symptoms in patients with advanced cancer. This trial will test a brief telehealth delivered psychosocial intervention c...
Eligibility Criteria
Inclusion
- Receiving cancer care at a Duke Cancer Network (DCN) clinic
- 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
Key Trial Info
Start Date :
June 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06555588
Start Date
June 11 2025
End Date
November 1 2028
Last Update
June 13 2025
Active Locations (1)
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1
Duke Cancer Network
Durham, North Carolina, United States, 27713