Engage Psychosocial Intervention for Cancer Symptoms
- Conditions
- Advanced Lung CancerAdvanced Colorectal CarcinomaAdvanced Colorectal AdenocarcinomaAdvanced Breast CancerAdvanced Prostate Cancer
- Interventions
- Behavioral: ENGAGEBehavioral: Supportive Care
- Registration Number
- NCT06555588
- Lead Sponsor
- Duke University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 190
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ENGAGE ENGAGE Behavioral symptom management focused on values identification and skills training. Supportive Care Supportive Care Education, support, and resources focused on common cancer-related concerns.
- Primary Outcome Measures
Name Time Method MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale 2 months 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.
- Secondary Outcome Measures
Name Time Method MD Anderson Symptom Inventory (MDASI) Interference with Daily Living Scale 4 months 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.
MD Anderson Symptom Inventory (MDASI) Symptom Severity Scale 2 months and 4 months This measure assesses the severity of pain, fatigue, and distress at their worst over the past 7 days. Items are scored from 0 = "not present" to 10 = "as bad as you can imagine". Each item is interpreted individually, with higher scores reflecting worse symptom severity.
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms 2 months and 4 months 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, relationships, or personal care. 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.
Openness to Experience subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT) 2 months and 4 months 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.
Behavioral Awareness subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT) 2 months and 4 months 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.
Valued Action subscale of the Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT) 2 months and 4 months 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.
Brief Pain Inventory (BPI) 2 months and 4 months 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.
Brief Fatigue Inventory (BFI) 2 months and 4 months 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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-Short Form 2 months and 4 months 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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression-Short Form 2 months and 4 months 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.
Functional Assessment of Cancer Therapy-General (FACT-G) 2 months and 4 months 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.
Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp) 2 months and 4 months 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.
Trial Locations
- Locations (1)
Duke Cancer Network
🇺🇸Durham, North Carolina, United States