Recruiting

Psychosocial Intervention

Sponsor:

Duke University

Code:

NCT06555588

Conditions

Advanced Breast Cancer

Advanced Prostate Cancer

Advanced Lung Cancer

Advanced Colorectal Carcinoma

Advanced Colorectal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ENGAGE

Supportive Care

Study Details

Brief 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.

Conditions

Advanced Breast Cancer

Advanced Prostate Cancer

Advanced Lung Cancer

Advanced Colorectal Carcinoma

Advanced Colorectal Adenocarcinoma

Study ID

NCT06555588

Start date

Jun 11, 2025

Status verified date

Mar, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion 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

Study Design

Enrollment

190 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

ENGAGE

This intervention is delivered by trained therapists over four, 45-60 minute, manualized telehealth sessions. The session content is based on an integration of Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) approaches for managing symptoms of pain, fatigue, and distress. Participants are trained in behavioral symptom management skills (e.g., activity pacing, mindfulness) with an emphasis on engaging in highly valued activities.

Supportive Care

This intervention is delivered by trained therapists over four, 45-60 minute, manualized telehealth sessions. The session content is designed to provide participants with education, support, and resources for a range of issues relevant to those with advanced cancer (e.g., education on symptoms, body image concerns, and financial concerns).

Primary outcome measure

  • MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Joseph G Winger, PhD

919-416-7506joseph.winger@duke.edu

Locations

Duke Cancer Network

Recruiting

Durham, North Carolina, United States, 27713

Contacts

Joseph G Winger, PhD

919-416-7506joseph.winger@duke.edu

More Information

Sponsor

Duke University

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-03-16.