Engage Psychosocial Intervention for Cancer Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-11

Study Completion Date

2028-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Online Psychosocial Intervention in Improving Social Well-Being and Support in Women With Stage I-IV Non-small Cell Lung Cancer Undergoing Treatment

NCT03731585

Non-Small Cell Lung Carcinoma Stage I Lung Cancer AJCC v8 Stage IA1 Lung Cancer AJCC v8 +13 more

ACTIVE_NOT_RECRUITING NA

Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer

NCT00037024

Breast Cancer Depression Fatigue +3 more

COMPLETED NA

Behavioral Activation-Led Activity Engagement for Cancer Empowerment

NCT06796608

Advanced Cancer Cancer

COMPLETED NA

Coping Together: Couple-based Interventions for Cancer

NCT04590885

Advanced Cancer

COMPLETED NA

Psychosocial Support in Treating Women With Recurrent Breast Cancer or Stage I, Stage II, or Stage IV Breast Cancer

NCT00416780

Breast Cancer Psychosocial Effects of Cancer and Its Treatment

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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., less than 7 vs. 7 to 10); and 2) cancer type (i.e., breast, prostate, lung, or colorectal).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ENGAGE

Behavioral symptom management focused on values identification and skills training.

Group Type EXPERIMENTAL

ENGAGE

Intervention Type BEHAVIORAL

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

Education, support, and resources focused on common cancer-related concerns.

Group Type ACTIVE_COMPARATOR

Supportive Care

Intervention Type BEHAVIORAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No