NCT06555588 · Duke University
Engage Psychosocial Intervention for Cancer Symptoms
(Engage)
What this study is about
The goal of this clinical trial is to test the effectiveness a new psychosocial symptom management intervention called ENGAGE for patients with Stage IV breast, prostate, lung, or colorectal cancer. Participants will be randomly assigned to ENGAGE or a Supportive Care intervention. Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months.
View original scientific description
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.
Interventions
BEHAVIORAL
ENGAGE
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.
BEHAVIORAL
Supportive Care
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).
Primary outcome measures
MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale
Time frame: 2 months
This measure assesses the degree to which, over the past 7 days, symptoms of pain, fatigue, and/or distress have interfered with patients' general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life. Items are scored from 0 = "Did not interfere" to 10 = "Interfered completely," and averaged for a composite score.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Durham, North Carolina
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 16, 2026 · Source of record for eligibility and locations