Engage Psychosocial Intervention for Cancer Symptoms

Duke University

Status: Begins enrollment in 1 month

Conditions: Advanced Colorectal Carcinoma; Advanced Prostate Cancer; Advanced Lung Cancer; Advanced Colorectal Adenocarcinoma; Advanced Breast Cancer

Treatments: Behavioral: ENGAGE; Behavioral: Supportive Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06555588

Pro00115646

R01CA291768 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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190 participants in 2 patient groups

ENGAGE

Experimental group

Description:

Behavioral symptom management focused on values identification and skills training.

Treatment:

Behavioral: ENGAGE

Supportive Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Supportive Care