Engage Psychosocial Intervention for Cancer Symptoms (NCT06555588) | Clinical Trial Compass
RecruitingNot Applicable
Engage Psychosocial Intervention for Cancer Symptoms
United States190 participantsStarted 2025-06-11
Plain-language 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. Participants will be randomized to ENGAGE or a Supportive Care intervention. Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale