Engage Psychosocial Intervention for Cancer Symptoms

Last updated: June 11, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer, Early, Recurrent

Treatment

ENGAGE

Supportive Care

Clinical Study ID

NCT06555588
Pro00115646
R01CA291768
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 atleast 2 symptoms

  • MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale averagescore 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

Exclusion Criteria:

  • Significant cognitive impairment indicated in medical chart or during telephonescreening on a mental status questionnaire

  • Serious psychiatric condition (e.g., schizophrenia, suicidal intent) that wouldcontraindicate safe study participation

  • Participation in the last 6 months in Cognitive-Behavioral Therapy or Acceptance andCommitment Therapy for cancer symptom management

  • Enrollment in hospice at screening

Study Design

Total Participants: 190
Treatment Group(s): 2
Primary Treatment: ENGAGE
Phase:
Study Start date:
June 11, 2025
Estimated Completion Date:
November 30, 2028

Study Description

Pain, fatigue, and distress are highly prevalent, co-occurring, and interfering symptoms in patients with advanced cancer. This trial will test a brief telehealth delivered psychosocial intervention called ENGAGE. ENGAGE aims to help patients decrease symptom interference and improve their quality of life. Patients with Stage IV cancer (breast, prostate, lung, or colorectal) and moderate-to-severe symptom interference will be randomized to ENGAGE or Supportive Care. Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months. Aim 1 is to determine ENGAGE's efficacy for reducing symptom interference (primary outcome) at 2 months (primary endpoint). Aim 2 is to determine ENGAGE's efficacy for improving secondary outcomes at 2 months. Aim 3 is to test the maintenance of ENGAGE's effects on primary and secondary outcomes at 4 months. An exploratory aim seeks insights for future implementation efforts using mixed-methods data collection from patients, oncology providers, and clinic leaders.

Connect with a study center

  • Duke Cancer Network

    Durham, North Carolina 27713
    United States

    Active - Recruiting

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