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Lay Coach-Led Early Palliative Care for Underserved Advanced Cancer Caregivers: The Project ENABLE Cornerstone RCT

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ClinicalTrials.gov Identifier: NCT04318886
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
University of South Alabama
Information provided by (Responsible Party):
James N Dionne-Odom, University of Alabama at Birmingham

Brief Summary:
Many of the 2.8 million family caregivers (FCGs) of persons with advanced cancer are underserved, particularly African-Americans and rural-dwellers in the Southern U.S.. Most have poor access and awareness of community-based palliative care services and have received no formal support or training despite providing assistance to their relatives an average of 8 hrs/day. Providing intense care and witnessing a close friend or family member struggle with advanced cancer can result in FCGs experiencing marked distress, particularly as their care recipients near end of life (EOL). Reports from NCI and NINR caregiving summits, systematic reviews, and the National Academy of Medicine have highlighted major limitations of cancer caregiver interventions, including a lack of attention to underserved populations and cost, poor scalability, over reliance on highly-trained professionals (e.g., nurses, psychologists, behavioral therapists), lengthy sessions over a short duration, and a lack of demonstrated impact on patient outcomes and healthcare utilization. To address this gap, the investigators have developed and tested feasibility and acceptability of a lay navigator-led early palliative care intervention called ENABLE Cornerstone for rural and minority family caregivers of persons with advanced cancer in the Southern U.S.. Evolving out of the team's prior trials and community stakeholder formative evaluation work, this multicomponent intervention is based on Pearlin's Stress-Health Process Model 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 over 6 brief in-person/telephonic sessions plus monthly follow-up from diagnosis through early bereavement. This proposed hybrid type I randomized effectiveness-implementation trial will determine whether ENABLE Cornerstone compared to usual care can improve family caregiver (Aim 1) and patient outcomes (Aim 2) and will evaluate implementation costs, cost effectiveness and healthcare utilization (Aim 3), over 24 weeks with 294 family caregivers and their patients with newly-diagnosed advanced cancer. To maximize recruitment, the investigators will recruit from two community cancer centers in Birmingham, AL and Mobile, AL. Our theory-driven, standardized approach is innovative because it uses lay navigators in collaboration with a palliative care interdisciplinary team to promote caregiver activation, skills and knowledge enhancement, as opposed to other difficult-to-implement intervention models that rely mostly on delivery of services by advanced practice professionals providing lengthy sessions over a short duration. If effectiveness is established, the ENABLE Cornerstone intervention offers a highly scalable and reproducible model of formal caregiver support that would be primed for dissemination and implementation.

Condition or disease Intervention/treatment Phase
Cancer Metastatic Family Members Behavioral: ENABLE Cornerstone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 588 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Lay Coach-Led Early Palliative Care for Underserved Advanced Cancer Caregivers: The Project ENABLE Cornerstone RCT
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
Experimental: Project ENABLE Cornerstone Behavioral: ENABLE Cornerstone
The ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone intervention is led by a specially-trained lay coach who is overseen by an interdisciplinary outpatient palliative care team, who employs health coaching techniques and caregiver distress assessment 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 over 6 brief in-person/telephonic sessions plus monthly follow-up from diagnosis through early bereavement.




Primary Outcome Measures :
  1. Distress (Family Caregiver) [ Time Frame: Baseline to 24 weeks ]
    Hospital Anxiety and Depression Scale - 14 items total (α=.92), 7 items measure anxiety (e.g., feeling tense, restless, worry), 7 items measure depressive symptoms (e.g., cheerfulness, feeling slowed down). Higher scores=worse anxiety/depression.


Secondary Outcome Measures :
  1. Quality of Life (Family Caregiver) [ Time Frame: Baseline to 24 weeks ]
    PROMIS Global Health 10 - 10 items, measures global health-related quality of life (HRQOL) in 2 domains: physical and mental health; scoring allows for estimates of cost effectiveness.115 Higher scores=higher HRQOL.

  2. Burden (Family Caregiver) [ Time Frame: Baseline to 24 weeks ]
    Montgomery-Borgatta Caregiver Burden Scale - 14 items, measures caregiver burden with 3 domains: objective burden, stress burden, and demand burden. Higher scores=higher burden.

  3. Distress (Patient) [ Time Frame: Baseline to 24 weeks ]
    Hospital Anxiety and Depression Scale - 14 items total (α=.92), 7 items measure anxiety (e.g., feeling tense, restless, worry), 7 items measure depressive symptoms (e.g., cheerfulness, feeling slowed down). Higher scores=worse anxiety/depression.

  4. Quality of Life (Patient) [ Time Frame: Baseline to 24 weeks ]
    PROMIS Global Health 10 - 10 items, measures global health-related quality of life (HRQOL) in 2 domains: physical and mental health; scoring allows for estimates of cost effectiveness.115 Higher scores=higher HRQOL.

  5. Healthcare Utilization (Patient) [ Time Frame: Baseline to 24 weeks ]
    Inpatient days, ICU days, ED visits, hospice use, palliative care provider visits, advance care planning conversation, AD completion, DNR orders (if patient does not enroll, items will be reported by FCG participants)


Other Outcome Measures:
  1. Implementation costs and cost effectiveness [ Time Frame: Baseline to 24 weeks ]
    Costs of implementation will include start-up and ongoing costs that will be necessary to implement ENABLE Cornerstone in other settings and will not include costs of intervention development and research activities. For cost effectiveness, incremental cost-effectiveness ratios (ICERs) will be calculated separately for health care payers and FCG-patient dyads, and measure the average net cost per QALY gained for intervention participants vs. usual care participants. ENABLE Cornerstone will be deemed cost-effective if ICERs are below those from CEAs of other caregiver interventions (if available) or below commonly used threshold of $50,000/$100,000 per QALY.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

FAMILY CAREGIVERS

Inclusion Criteria:

  • Self-endorsing or identified by the patient as "an unpaid spouse/partner, relative or friend who knows them well and who provides regular support due to their cancer and who does not have to live in the same dwelling"
  • Either: a) caring for a patient residing in a rural zip code (classified by the U.S. Census' Rural-Urban Commuting Area Codes (RUCAs) system as small rural, large rural, and isolated [hereafter referred to as "rural"]) or b) be African-American
  • Caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below)
  • Caregivers will NOT need to have an agreeable patient willing to participate in the study
  • English-speaking and able to complete baseline measures

Exclusion Criteria:

  • Self-reported active severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse

PATIENTS (data collection only)

Inclusion Criteria:

  • Diagnosed within past 60 days of initial pre-screening with an advanced cancer, defined as metastatic and/or recurrent/progressive stage III/IV cancer, including brain, lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, and hematologic malignancies
  • English-speaking and able to complete baseline measures

Exclusion Criteria:

  • Receiving hospice; or
  • Medical record documentation or self-report of active severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318886


Contacts
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Contact: Sally Engler, MPH (205) 996-7564 sengler@uab.edu

Sponsors and Collaborators
University of Alabama at Birmingham
University of South Alabama
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Responsible Party: James N Dionne-Odom, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04318886    
Other Study ID Numbers: R01CA252868
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James N Dionne-Odom, University of Alabama at Birmingham:
palliative care
supportive care
family caregiver
rural
African American
telehealth