NCT06555588 Engage Psychosocial Intervention for Cancer Symptoms
| NCT ID | NCT06555588 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Advanced Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2025-06-11 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 190 participants in total. It began in 2025-06-11 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06555588 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06555588 currently recruiting?
Yes, NCT06555588 is actively recruiting participants. Contact the research team at joseph.winger@duke.edu for enrollment information.
Where is the NCT06555588 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06555588 clinical trial?
NCT06555588 is sponsored by Duke University. The trial plans to enroll 190 participants.
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