Engage Psychosocial Intervention for Cancer Symptoms

Trial Title: Engage Psychosocial Intervention for Cancer Symptoms

NCT ID: NCT06555588

Condition: Advanced Breast Cancer
Advanced Prostate Cancer
Advanced Lung Cancer
Advanced Colorectal Carcinoma
Advanced Colorectal Adenocarcinoma

Conditions: Official terms:
Colorectal Neoplasms

Conditions: Keywords:
Acceptance and Commitment Therapy
Cognitive Behavioral Therapy
Pain management
Fatigue management
Symptom management
Telehealth
Psychosocial intervention

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Participants will be randomly assigned with equal (1:1) allocation to either ENGAGE or Supportive Care. A stratified block randomization scheme will be used to ensure group balance based on: 1) the primary outcome of symptom interference (i.e., 3 to 6 vs. 7 to 10); and 2) cancer type (i.e., breast, prostate, lung, or colorectal).

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Behavioral
Intervention name: ENGAGE
Description: 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.
Arm group label: ENGAGE

Intervention type: Behavioral
Intervention name: Supportive Care
Description: 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).
Arm group label: Supportive Care

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: February 2025

Completion date: July 2029

Lead sponsor:
Agency: Duke University
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Duke University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06555588