Clinical trial NCT06555588: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Breast Cancer
Advanced Prostate Cancer
Advanced Lung Cancer
Advanced Colorectal Carcinoma
Advanced Colorectal Adenocarcinoma
Keywords: Acceptance and Commitment Therapy
Cognitive Behavioral Therapy
Pain management
Fatigue management
Symptom management
Telehealth
Psychosocial intervention
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-08-15
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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., less than 7 vs. 7 to 10); and 2) cancer type (i.e., breast, prostate, lung, or colorectal).
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale
timeFrame: 2 months
Secondary outcomes:
measure: MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale
timeFrame: 4 months
measure: MD Anderson Symptom Inventory (MDASI) Symptom Severity Scale
timeFrame: 2 months and 4 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms
timeFrame: 2 months and 4 months
measure: Openness to Experience subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT)
timeFrame: 2 months and 4 months
measure: Behavioral Awareness subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT)
timeFrame: 2 months and 4 months
measure: Valued Action subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT)
timeFrame: 2 months and 4 months
measure: Brief Pain Inventory (BPI)
timeFrame: 2 months and 4 months
measure: Brief Fatigue Inventory (BFI)
timeFrame: 2 months and 4 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-Short Form
timeFrame: 2 months and 4 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Depression-Short Form
timeFrame: 2 months and 4 months
measure: Functional Assessment of Cancer Therapy-General (FACT-G)
timeFrame: 2 months and 4 months
measure: Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp)
timeFrame: 2 months and 4 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Network
state: North Carolina
Study officials:
References: