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Engage Psychosocial Intervention for Cancer Symptoms
RECRUITINGN/ASponsored by Duke University
Actively Recruiting
PhaseN/A
SponsorDuke University
Started2025-06-11
Est. completion2028-09
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06555588
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
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * 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 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
Conditions8
Advanced Breast CancerAdvanced Colorectal AdenocarcinomaAdvanced Colorectal CarcinomaAdvanced Lung CancerAdvanced Prostate CancerBreast CancerCancerLung Cancer
Locations1 site
Duke Cancer Network
Durham, North Carolina, 27713
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhaseN/A
SponsorDuke University
Started2025-06-11
Est. completion2028-09
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06555588