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RecruitingNot applicableNCT06555588
Official study title

Engage Psychosocial Intervention for Cancer Symptoms

Study 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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedENGAGE and Supportive Care

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 16, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Duke University

Study sponsor

01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
Duke University
Interventions being studied
Behavioral: ENGAGE; Behavioral: Supportive Care
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting
Metastatic or stage IV→
Treatment approach
Supportive or behavioral care→
Study topics
Survivorship and quality of life→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Duke Cancer NetworkDurham, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 16, 2026. Always confirm current availability with the study team.

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