Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06555588

Engage: A Telehealth-Delivered Psychosocial Intervention to Decrease Symptom Interference in Patients With Advanced Cancer

Led by Duke University · Updated on 2026-03-16

190

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new telehealth-delivered psychosocial intervention called ENGAGE for patients with Stage IV breast, prostate, lung, or colorectal cancer who experience moderate-to-severe symptom interference. This trial aims to test the effectiveness of ENGAGE in reducing symptoms like pain, fatigue, and distress that commonly affect quality of life in advanced cancer. The study compares ENGAGE to a Supportive Care intervention, focusing on patient-reported outcomes over time. Participants will be randomly assigned to receive either ENGAGE or Supportive Care. Both interventions involve four telehealth sessions lasting 45 to 60 minutes each, delivered by trained therapists. ENGAGE combines cognitive behavioral therapy and acceptance and commitment therapy techniques to teach behavioral symptom management skills and encourage engagement in meaningful activities. Supportive Care provides education, support, and resources addressing common cancer-related concerns such as symptoms, body image, and financial issues. During the study, participants will complete assessments at the start, 2 months, and 4 months to measure symptom interference and other outcomes using tools like the MD Anderson Symptom Inventory and PROMIS questionnaires. The research will track the impact on symptom severity, self-efficacy in managing symptoms, anxiety, depression, and quality of life. Data collection will also include feedback from patients, oncology providers, and clinic leaders to inform future implementation. The trial is expected to continue through November 2028.

CONDITIONS

Brief Title

Engage Psychosocial Intervention for Cancer Symptoms

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Receiving cancer care at a Duke Cancer Network clinic or Duke Cancer Institute and living at least 60 miles from Duke in a rural county
  • Oncologist confirmed Stage IV breast, prostate, lung, or colorectal cancer
  • Moderate-to-severe pain, fatigue, or distress with a rating of 3 or higher out of 10 for at least two symptoms in the past 7 days
  • Average score of 3 or higher out of 10 on the MD Anderson Symptom Inventory Interference with Daily Living Scale 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 sufficient to complete telehealth sessions
Not Eligible

You will not qualify if you...

  • Significant cognitive impairment as noted in medical records or during telephone screening
  • Serious psychiatric conditions such as schizophrenia or suicidal intent that would make participation unsafe
  • Participation in cognitive-behavioral therapy or acceptance and commitment therapy for cancer symptom management within the last 6 months
  • Enrollment in hospice care at screening

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (telehealth or phone)

Outpatient Treatment

Duration - Approximately 4 to 6 weeks

Participants receive four telehealth sessions delivered by trained therapists focusing on either behavioral symptom management or education and support for cancer-related concerns.

4 telehealth sessions

Follow-up

Duration - Up to 4 months

Participants complete patient-reported outcome assessments to evaluate symptom interference and other secondary outcomes at 2 and 4 months after starting treatment.

Assessment visits at 2 months and 4 months (telehealth or remote)

Trial Site Locations

Total: 1 location

1

Duke Cancer Network

Durham, North Carolina, United States, 27713

Actively Recruiting

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Research Team

J

Joseph G Winger, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Engage: Protocol of a randomized controlled trial of a telehealth-delivered psychosocial intervention to decrease symptom interference in patients with advanced cancer.

Joseph G Winger, Sarah A Kelleher, Justin A Yu...

https://pubmed.ncbi.nlm.nih.gov/40834926