Engage: A Randomized Controlled Trial Testing the Efficacy of a Telehealth-Delivered Psychosocial Intervention to Decrease Symptom Interference in Patients With Advanced Cancer

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 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

Locations
United States
North Carolina
Duke Cancer Network
RECRUITING
Durham
Contact Information
Primary
Joseph G Winger, PhD
joseph.winger@duke.edu
919-416-7506
Time Frame
Start Date: 2025-06-11
Estimated Completion Date: 2028-11
Participants
Target number of participants: 190
Treatments
Experimental: ENGAGE
Behavioral symptom management focused on values identification and skills training.
Active_comparator: Supportive Care
Education, support, and resources focused on common cancer-related concerns.
Sponsors
Leads: Duke University
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov