Engage Psychosocial Intervention for Cancer Symptoms

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06555588
Status
Recruiting
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Conditions

  • Advanced Breast Cancer
  • Advanced Colorectal Adenocarcinoma
  • Advanced Colorectal Carcinoma
  • Advanced Lung Cancer
  • Advanced Prostate Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ENGAGE — BEHAVIORAL
    This intervention is delivered by trained therapists over four, 45-60 minute, manualized telehealth sessions. The session content is based on an integration of Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) approaches for managing symptoms of pain, fatigue, and distress. Participants are trained in behavioral symptom management skills (e.g., activity pacing, mindfulness) with an emphasis on engaging in highly valued activities.
  • Supportive Care — BEHAVIORAL
    This intervention is delivered by trained therapists over four, 45-60 minute, manualized telehealth sessions. The session content is designed to provide participants with education, support, and resources for a range of issues relevant to those with advanced cancer (e.g., education on symptoms, body image concerns, and financial concerns).

Study Details

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.

Key Dates

Start date
Jun 11, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: ENGAGE
    Behavioral symptom management focused on values identification and skills training.
  • Active Comparator: Supportive Care
    Education, support, and resources focused on common cancer-related concerns.

Primary Outcome Measure

MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale [ Time Frame: 2 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Cancer NetworkDurhamNorth Carolina27713
Joseph G Winger, PhD
[email protected]
919-416-7506

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By research site
Duke Cancer Network· Durham, NC

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