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.
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
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
Parallel
ENGAGE
BehavioralThis 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.
Supportive Care
BehavioralThis 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).
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.
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.
MD Anderson Symptom Inventory (MDASI) Symptom Severity Scale
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
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)
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.
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Duke University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
