Engage Psychosocial Intervention for Cancer Symptoms

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

Overview

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.

Interventions

• Behavioral 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.
• 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).

Primary outcome measures

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

Secondary outcome measures (12)

• MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale [Time frame: 4 months]
• MD Anderson Symptom Inventory (MDASI) Symptom Severity Scale [Time frame: 2 months and 4 months]
• Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms [Time frame: 2 months and 4 months]
• Openness to Experience subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT) [Time frame: 2 months and 4 months]
• Behavioral Awareness subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT) [Time frame: 2 months and 4 months]
• Valued Action subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT) [Time frame: 2 months and 4 months]
• Brief Pain Inventory (BPI) [Time frame: 2 months and 4 months]
• Brief Fatigue Inventory (BFI) [Time frame: 2 months and 4 months]
• Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-Short Form [Time frame: 2 months and 4 months]
• Patient-Reported Outcomes Measurement Information System (PROMIS) Depression-Short Form [Time frame: 2 months and 4 months]
• Functional Assessment of Cancer Therapy-General (FACT-G) [Time frame: 2 months and 4 months]
• Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp) [Time frame: 2 months and 4 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Duke Cancer Network — Durham

Publications

• Winger JG, Kelleher SA, Yu JA, Ma JE, Majestic CM, Martinson EB, Olsen MK, Lerebours R, Sutton LM, Somers TJ. Engage: Protocol of a randomized controlled trial of a telehealth-delivered psychosocial intervention to decrease symptom interference in patients with advanced cancer. Contemp Clin Trials. 2025 Sep;156:108053. doi: 10.1016/j.cct.2025.108053. Epub 2025 Aug 18. PMID 40834926

Identifiers

NCT: NCT06555588 · Pro00115646 · R01CA291768

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗