Engage Psychosocial Intervention for Cancer Symptoms
Recruiting · NCT06555588 · Interventional (participants receive a specific treatment) · Lead sponsor: Duke University
View the official record on ClinicalTrials.gov →Interventions studied
ENGAGESupportive Care
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
3 locations listed across 1 US state.
- Duke Cancer Network - Durham, North Carolina, United States
- Duke Cancer Network - Durham, North Carolina, United States
- Duke Cancer Network - Durham, North Carolina, United States