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

Summary

Multi-Year Funded Merit Award - Years 6-7:

For this 2-year merit award funding, we propose to continue enrollment beyond 24-weeks and extend follow-up with participants long-term, through the patient's end of life and for 24 weeks post-patient death to test the effectiveness of Cornerstone on caregiver and patient outcomes compared to usual care.

* Hypothesis Primary Aim 1: Compared to usual care, Cornerstone caregiver participants will report lower distress as measured by the Hospital Anxiety and Depression Scale in the 24 weeks prior to death.
* Hypotheses Secondary Aim 1: Compared to usual care, Cornerstone participants will report better a) QOL (PROMIS Global Health 10)40,54 and b) lower burden (Montgomery-Borgatta Burden Scale)39 in the 24 weeks prior to death.
* Hypotheses Aim 2: Compared to usual care, Cornerstone participants' care recipients will report a) lower distress as measured by the Hospital Anxiety and Depression Scale (HADS), b) better QOL, c) better quality of death and dying, and d) lower healthcare utilization, including EOL healthcare utilization, in the 24 weeks prior to deathAim 3: Test the long-term effects of Cornerstone on caregiver bereavement outcomes.
* Hypotheses Aim 3: Compared to usual care, Cornerstone caregiver participants will report a) lower distress (HADS), b) higher QOL, c) lower burden, d) higher resilience, and e) lower grief over 24 weeks post-patient death.

* Parent Study - Years 1 - 5: This hybrid type I randomized effectiveness-implementation trial is designed to answer the question "Is ENABLE Cornerstone efficacious in enhancing caregiver and patient outcomes?" The primary aims are to assess the effectiveness of ENABLE Cornerstone over 24 weeks (Primary and Secondary Aim). The investigators will also explore implementation cost and cost effectiveness, including healthcare utilization (Aim 3) and other potential mediator/moderator effects of the intervention on coping, social support, and preparedness (Exploratory Aim). The study will recruit 206 family caregivers over the age of 21 reporting that they are the primary unpaid provider of support to a close family member or friend who has been newly-diagnosed with an advanced stage cancer within the past 60 days. Half of the participants will be randomized to ENABLE Cornerstone (n=103) which consists of 6 brief, weekly in-person/telephone sessions followed by monthly follow-up every 4 weeks as needed by participants. The other half will be assigned to a usual care condition (n=103).

Conditions

• Cancer Metastatic
• Family Members

Interventions

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Alabama at Birmingham

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-07

Primary Completion

2025-12-31

Completion

2027-06-30

Countries

• United States

Study Locations