Engage Psychosocial Intervention for Cancer Symptoms
NCT Number: NCT06555588
Acronym: Engage
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Advanced Breast Cancer|Advanced Prostate Cancer|Advanced Lung Cancer|Advanced Colorectal Carcinoma|Advanced Colorectal Adenocarcinoma
Interventions: BEHAVIORAL: ENGAGE|BEHAVIORAL: Supportive Care
Sponsor: Duke University
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 190
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-02
Completion Date: 2029-07

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.

Primary Outcome Measures: MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale, This measure assesses the degree to which, over the past 7 days, symptoms of pain, fatigue, and/or distress have interfered with patients' general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life. Items are scored from 0 = "Did not interfere" to 10 = "Interfered completely," and averaged for a composite score., 2 months
Secondary Outcome Measures: MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale, This measure assesses the degree to which, over the past 7 days, symptoms of pain, fatigue, and/or distress have interfered with patients' general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life. Items are scored from 0 = "Did not interfere" to 10 = "Interfered completely," and averaged for a composite score., 4 months|Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms, This measure assesses patients' level of confidence to manage or control their symptoms, manage their symptoms in different settings, and to keep symptoms from interfering with work, sleep, relationships, or recreational activities. Items are scored from 1 = "I am not confident at all" to 5 = "I am very confident." Items are summed and converted to T-scores, with higher scores indicating better self-efficacy., 2 months and 4 months|Openness to Experience subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT), This subscale assesses patients' openness to experience difficult thoughts, emotions, and sensations (i.e., psychological acceptance). Items are scored from 0 = "strongly disagree" to 6 = "strongly agree," with higher scores indicating more acceptance. Items are averaged for a composite score., 2 months and 4 months|Behavioral Awareness subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT), This subscale assesses patients' level of present moment awareness (i.e., mindfulness). Items are scored from 0 = "strongly disagree" to 6 = "strongly agree," with higher scores indicating more mindfulness. items are averaged for a composite score., 2 months and 4 months|Valued Action subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT), This subscale assesses patients' degree of values identification and willingness to take actions that align with their personal values. Items are scored from 0 = "strongly disagree" to 6 = "strongly agree," with higher scores indicating more values identification and engagement. Items are averaged for a composite score., 2 months and 4 months|Brief Pain Inventory (BPI), This pain severity measure assesses pain at its worst, least, average, and now. Response options range from 0 = "no pain" to 10 = "pain as bad as you can imagine". items are averaged for a composite score., 2 months and 4 months|Brief Fatigue Inventory (BFI), This fatigue severity measure assesses fatigue over the last 7 days from 0 = "no fatigue" to 10 = "as bad as you can imagine" at its usual, worst, and right now. Items are averaged for a composite score., 2 months and 4 months|Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-Short Form, This anxiety symptom measure assesses fear, worry, uneasiness, nervousness, and tension. Response options range from 1 = "never" to 5 = "always." Items are summed and converted to T-scores, with higher scores indicating worse anxiety symptoms., 2 months and 4 months|Patient-Reported Outcomes Measurement Information System (PROMIS) Depression-Short Form, This depressive symptoms measure assesses worthlessness, helplessness, hopelessness, depressed mood, failure, and sadness. Response options range from 1 = "never" to 5 = "always." Items are summed and converted to T-scores, with higher scores indicating worse depressive symptoms., 2 months and 4 months|Functional Assessment of Cancer Therapy-General (FACT-G), This quality of life measure is composed of 4 subscales: physical, social/family, emotional, and functional well-being. Items are rated on a 0 = "not at all" to 4 = "very much" scale and summed for subscale scores and an overall quality of life score., 2 months and 4 months|Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp), This measure includes an overall spiritual well-being score and three subscales: 1) meaning (i.e., reason for living, sense of meaning and purpose); 2) peace (i.e., feeling peaceful, sense of harmony within oneself); and 3) faith (i.e., finding strength and comfort in faith or spiritual beliefs). Response options range from 0 = "not at all" to 4 = "very much"; two items are reverse coded. Higher scores indicate greater spiritual well-being., 2 months and 4 months