About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ENGAGE
- Supportive Care
Treatment groups
Sponsors and collaborators
Duke University
Lead sponsor
National Cancer Institute (NCI)
Collaborator