RECRUITING

Engage Psychosocial Intervention for Cancer Symptoms

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05
Study Completion:2029-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06555588

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Receiving cancer care at a Duke Cancer Network (DCN) clinic
  2. * Oncologist confirmed Stage IV breast, prostate, lung, or colorectal cancer
  3. * Worst pain, fatigue, or distress rated at \>/= 3 out of 10 in the past 7 days for at least 2 symptoms
  4. * MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale average score of \>/= 3 out of 10 in the past 7 days
  5. * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
  6. * At least 18 years old
  7. * Ability to speak and read English
  8. * Hearing and vision that allows for successful completion of telehealth sessions
  1. * Significant cognitive impairment indicated in medical chart or during telephone screening on a mental status questionnaire
  2. * Serious psychiatric condition (e.g., schizophrenia, suicidal intent) that would contraindicate safe study participation
  3. * Participation in the last 6 months in Cognitive-Behavioral Therapy or Acceptance and Commitment Therapy for cancer symptom management
  4. * Enrollment in hospice at screening

Contacts and Locations

Study Contact

Joseph G Winger, PhD
CONTACT
919-416-7506
joseph.winger@duke.edu

Study Locations (Sites)

Duke Cancer Network
Durham, North Carolina, 27713
United States

Collaborators and Investigators

Sponsor: Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05
Study Completion Date2029-07

Study Record Updates

Study Start Date2025-05
Study Completion Date2029-07

Terms related to this study

Keywords Provided by Researchers

  • Acceptance and Commitment Therapy
  • Cognitive Behavioral Therapy
  • Pain management
  • Fatigue management
  • Symptom management
  • Telehealth
  • Psychosocial intervention

Additional Relevant MeSH Terms

  • Advanced Breast Cancer
  • Advanced Prostate Cancer
  • Advanced Lung Cancer
  • Advanced Colorectal Carcinoma
  • Advanced Colorectal Adenocarcinoma