Engage Psychosocial Intervention for Cancer Symptoms
Engage
Engage: A Randomized Controlled Trial Testing the Efficacy of a Telehealth-Delivered Psychosocial Intervention to Decrease Symptom Interference in Patients With Advanced Cancer
2 other identifiers
interventional
190
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2024
CompletedFirst Posted
Study publicly available on registry
August 15, 2024
CompletedStudy Start
First participant enrolled
June 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
March 16, 2026
March 1, 2026
3.2 years
August 13, 2024
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale
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.
2 months
Secondary Outcomes (12)
MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale
4 months
MD Anderson Symptom Inventory (MDASI) Symptom Severity Scale
2 months and 4 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms
2 months and 4 months
Openness to Experience subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT)
2 months and 4 months
Behavioral Awareness subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT)
2 months and 4 months
- +7 more secondary outcomes
Study Arms (2)
ENGAGE
EXPERIMENTALBehavioral symptom management focused on values identification and skills training.
Supportive Care
ACTIVE COMPARATOREducation, support, and resources focused on common cancer-related concerns.
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Duke Cancer Network
Durham, North Carolina, 27713, United States
Related Publications (1)
Winger JG, Kelleher SA, Yu JA, Ma JE, Majestic CM, Martinson EB, Olsen MK, Lerebours R, Sutton LM, Somers TJ. Engage: Protocol of a randomized controlled trial of a telehealth-delivered psychosocial intervention to decrease symptom interference in patients with advanced cancer. Contemp Clin Trials. 2025 Sep;156:108053. doi: 10.1016/j.cct.2025.108053. Epub 2025 Aug 18.
PMID: 40834926DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2024
First Posted
August 15, 2024
Study Start
June 11, 2025
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- The dataset will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. Data will be available for at least 6 years.
- Access Criteria
- The dataset and supporting information will be made available to qualified investigators to allow replication of analyses or secondary data analyses. The PI will review requests for data access. The investigators will be required to sign a data use agreement and obtain IRB approval before receiving the data set. The mechanism for data sharing will be reviewed by the IRB. The investigators requesting the data will need to cite the original study. Users of the public use data must register with National Cancer Institute's Cancer Data Service (CDS) and agree to the Terms of Use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, and requiring immediate reporting of any disclosure of study participant identity. Data users also agree not to share or redistribute any data downloads.
Results of this trial will be presented at professional meetings and published in peer-reviewed journals. The dataset will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. The dataset will contain necessary identifiers, excluding those prohibited by HIPAA. The investigators will be required to sign a data use agreement and obtain Institutional Review Board (IRB) approval before receiving the data set. Public use study data and associated documentation will also be made available to the research community through the National Cancer Institute's Cancer Data Service (CDS) data repository.