Lay Coach-Led Palliative Care for Cancer

Overseen By James N Odom, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Alabama at Birmingham

Disqualifiers: Severe mental illness, Dementia, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

412 Participants Needed

Trial Summary

What is the purpose of this trial?

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 206 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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems focused on providing support and education for caregivers, so it's unlikely that medication changes are required.

What data supports the effectiveness of the treatment ENABLE Cornerstone for cancer?

Research shows that early palliative care, like ENABLE Cornerstone, can improve the quality of life for patients with advanced cancer and support their caregivers, especially in underserved communities. ^{1 2 3 4 5}

How is the ENABLE Cornerstone treatment different from other cancer treatments?

ENABLE Cornerstone is unique because it is a lay coach-led, early palliative care intervention specifically designed to support family caregivers of patients with advanced cancer, particularly focusing on African American and rural-dwelling populations. Unlike traditional treatments, it emphasizes early support through telehealth, addressing problem-solving, advance care planning, and self-care. ^{1 3 4 6 7}

Eligibility Criteria

This trial is for English-speaking family caregivers of patients with advanced-stage cancer, who are either living in rural areas or are African-American. Caregivers can participate without the patient's involvement and do not need to live with them. Those with severe mental illness, dementia, suicidal thoughts, hearing loss, or substance abuse cannot join.

Inclusion Criteria

I have a close person who supports me with my cancer care but doesn't live with me.

I was diagnosed with advanced cancer less than 60 days ago.

Caring for a patient with advanced-stage cancer

Exclusion Criteria

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

I do not have severe mental illness, dementia, suicidal thoughts, untreated hearing loss, or active substance abuse.

I am currently receiving hospice care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ENABLE Cornerstone intervention, consisting of 6 brief, weekly in-person/telephone sessions

6 weeks

6 visits (in-person/telephone)

Follow-up

Monthly follow-up sessions to monitor caregiver and patient outcomes, including distress and quality of life

18 weeks

Monthly follow-up (as needed)

Long-term Follow-up

Participants are monitored for sustained effects of the intervention at the patient's end-of-life and post death

Ongoing

Treatment Details

Interventions

• ENABLE Cornerstone

Trial Overview The ENABLE Cornerstone program is being tested to see if it helps caregivers manage stress and improve their caregiving skills through six brief sessions plus monthly follow-ups by lay navigators overseen by a palliative care team. The study compares this approach against usual care over 24 weeks.

Participant Groups

Group I: Project ENABLE Cornerstone Experimental Treatment 1 Intervention

Group II: Usual Care Active Control 1 Intervention

ENABLE Cornerstone is already approved in United States for the following indications:

Approved in United States as Project ENABLE for:

• Palliative care for advanced cancer patients and their caregivers

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

University of South Alabama

Collaborator

Trials

44

Recruited

15,800+

Findings from Research

The ENABLE Cornerstone program, a telehealth intervention for family caregivers of patients with advanced cancer, showed high acceptability with an average recommendation rating of 9.4 out of 10, and a completion rate of 87% for questionnaires.

Caregivers in the intervention group experienced a reduction in anxiety and depression symptoms over 24 weeks, while those receiving usual care reported worsening symptoms, suggesting the potential efficacy of the program in supporting caregiver mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A lay navigator-led, early palliative care intervention for African American and rural family caregivers of individuals with advanced cancer (Project Cornerstone): Results of a pilot randomized trial. Dionne-Odom, JN., Azuero, A., Taylor, RA., et al.[2023]

Participants in the ENABLE II trial reported significant benefits from the palliative care intervention, including improved problem-solving skills, better coping mechanisms, and a sense of empowerment and support.

The positive experiences of trial participation, such as contributing to future patient care and gaining insights from questionnaires, outweighed any burdens, suggesting that early palliative care can enhance the quality of life for advanced cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perspectives on participation in the ENABLE II randomized controlled trial of a concurrent oncology palliative care intervention: benefits and burdens. Maloney, C., Lyons, KD., Li, Z., et al.[2022]

Project ENABLE Cornerstone is a tailored telehealth intervention designed to support family caregivers of African American and rural-dwelling patients with newly diagnosed advanced cancer, focusing on stress management and coping skills through six telehealth sessions.

The study aims to evaluate the effectiveness of this intervention in reducing caregiver distress and improving quality of life, with a target sample size of 294 caregiver-patient dyads, potentially providing a culturally sensitive model for early palliative care support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Project ENABLE Cornerstone randomized controlled trial: study protocol for a lay navigator-led, early palliative care coaching intervention for African American and rural-dwelling advanced cancer family caregivers. Bechthold, AC., Azuero, A., Pisu, M., et al.[2022]

A toolkit was developed to help community cancer centers, especially in rural areas, implement early concurrent palliative care for patients with newly diagnosed metastatic cancer, guided by the RE-AIM framework.

Four specific instruments were created to measure the implementation of the ENABLE model, including tools for assessing reach, organizational readiness, costs, and clinician perceptions, which have been pilot-tested for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a "toolkit" to measure implementation of concurrent palliative care in rural community cancer centers. Zubkoff, L., Dionne-Odom, JN., Pisu, M., et al.[2018]

Out of 536 patients with advanced cancer, 45% were referred to palliative care (PC), with significant differences in access based on cancer type, particularly higher access for breast and gynecological cancers.

Patients referred to PC received less aggressive treatments, such as chemotherapy and intensive care, in their final weeks of life, indicating that PC may lead to a more comfortable end-of-life experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care referral and associated outcomes among patients with cancer in the last 2 weeks of life. Ledoux, M., Rhondali, W., Lafumas, V., et al.[2019]

The ENABLE palliative care model was found to be culturally acceptable among patients with advanced cancer and their caregivers in Singapore, highlighting the need for psychosocial support earlier in the illness trajectory.

Participants recommended modifications to the program, such as ensuring content is suitable for patients who may not fully understand their diagnosis and preferring face-to-face sessions to enhance rapport with healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting ENABLE for patients with advanced cancer and their family caregivers in Singapore: a qualitative formative evaluation. Yang, GM., Dionne-Odom, JN., Foo, YH., et al.[2021]

In a study of 744 newly referred patients to Palliative Care Consultation Teams (PCCTs) in France, it was found that 88% were inpatients and 74% had died within 6 months, highlighting the late referral to palliative care services.

The study indicates that cancer patients make up the majority of referrals, and those referred earlier tended to have a higher likelihood of dying in a Palliative Care Unit, suggesting that earlier intervention could improve end-of-life care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration and activity of hospital-based palliative care consultation teams: the INSIGHT multicentric cohort study. Vinant, P., Joffin, I., Serresse, L., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

A lay navigator-led, early palliative care intervention for African American and rural family caregivers of individuals with advanced cancer (Project Cornerstone): Results of a pilot randomized trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Patient perspectives on participation in the ENABLE II randomized controlled trial of a concurrent oncology palliative care intervention: benefits and burdens. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The Project ENABLE Cornerstone randomized controlled trial: study protocol for a lay navigator-led, early palliative care coaching intervention for African American and rural-dwelling advanced cancer family caregivers. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Developing a "toolkit" to measure implementation of concurrent palliative care in rural community cancer centers. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Palliative care referral and associated outcomes among patients with cancer in the last 2 weeks of life. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Adapting ENABLE for patients with advanced cancer and their family caregivers in Singapore: a qualitative formative evaluation. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Integration and activity of hospital-based palliative care consultation teams: the INSIGHT multicentric cohort study. [2018]