This clinical trial studies the use of a lay navigator-led early palliative care intervention called ENABLE Cornerstone in underserved patients with cancer that has spread to other places in the body (advanced) and their caregivers. The ENABLE Cornerstone is a multicomponent intervention where lay navigators, overseen by an interdisciplinary outpatient palliative care team, employ health coaching techniques and caregiver distress screening to behaviorally activate and reinforce psychoeducation on managing stress and coping, getting and asking for help, improving caregiving skills, and decision-making/advance care planning. ENABLE Cornerstone may lower distress, reduce burden, and improve quality of life in family caregivers and cancer patients.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04318886.
PRIMARY OBJECTIVES:
I. Test the effect of Educate, Nurture, Advise, Before Life Ends (ENABLE) Cornerstone on caregiver outcomes.
II. Test the effect of ENABLE Cornerstone on patient outcomes.
III. Evaluate implementation costs and the cost effectiveness of ENABLE Cornerstone implementation on caregiver and patient outcomes.
EXPLORATORY OBJECTIVE:
I. Explore mediators and moderators of the relationship between the intervention and caregiver and patient outcomes.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I (USUAL CARE): Patients and family caregivers receive usual care. Patients and family caregivers also complete questionnaires at baseline and every 12 weeks.
ARM II (ENABLE CORNERSTONE): Family caregivers complete 6 in-person or telephone coaching sessions with a supportive care coach over 20-60 minutes each, every 1-2 weeks or as able to be scheduled. Patients and family caregivers also complete questionnaires at baseline and every 12 weeks.
After completion of study, family caregivers are followed up every 4 weeks for up to 1 year after a care recipient’s death.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Alabama at Birmingham Cancer Center
Principal InvestigatorJames Nicholas Odom