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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called ENABLE Cornerstone to determine its effectiveness in helping family caregivers of people with advanced cancer. The goal is to enhance caregivers' well-being, as they often experience distress while supporting loved ones with cancer. Lay navigators (trained non-professionals) guide caregivers through stress management, caregiving skills, and future planning over six sessions. The trial seeks caregivers assisting someone with advanced-stage cancer, particularly those who are African-American or live in rural areas. Participants must speak English and provide unpaid care regularly. As a Phase 3 trial, this program represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking support system for caregivers.

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 prior data suggests that the ENABLE Cornerstone intervention is safe for family caregivers of persons with advanced cancer?

Research has shown that the ENABLE Cornerstone program is generally safe for family caregivers. Previous studies with similar programs found that caregivers handle the program well. These studies also indicate that caregivers value the support and education about mental and emotional health provided by trained helpers. No major reports of harm or serious side effects have emerged from the program. This suggests that the ENABLE Cornerstone program is a safe choice for those considering joining a clinical trial to reduce caregiver stress and improve coping skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional palliative care for cancer, which typically involves professional healthcare providers, ENABLE Cornerstone is unique because it empowers lay coaches to deliver supportive care. This approach taps into the potential of trained non-professionals to provide emotional and practical support, making palliative care more accessible to patients. Researchers are excited about this method because it could expand the reach of palliative care, offering personalized support and improving quality of life for more people facing cancer.

What evidence suggests that the ENABLE Cornerstone intervention is effective for family caregivers of persons with advanced cancer?

Research has shown that the ENABLE Cornerstone program, which participants in this trial may receive, can assist family members caring for patients with advanced cancer. In past studies, family caregivers who participated in the program managed stress better and enhanced their caregiving skills. Trained community members, known as lay navigators, provide support and education through this program. It has proven particularly beneficial for African-American and rural caregivers. By focusing on practical skills and emotional support, the program offers a simpler alternative to more complex programs run by professionals. Early results indicate that caregivers feel more prepared to handle caregiving challenges, improving the quality of life for both caregivers and patients. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 am currently receiving hospice care.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6872851/

The project ENABLE Cornerstone randomized pilot trial A lay navigator-led, early palliative care coaching intervention for family caregivers of African-American and rural-dwelling patients with newly-diagnosed ...

2. uab.edu uab.edu/medicine/palliativecare/images/ProjectENABLE.pdf

Project ENABLE (Educate, Nurture, Advise Before Life Ends) Over 300 patients enrolled over 4 years: Half of the patients received ENABLE and half received usual cancer care. Family caregivers did not receive a specific ...

3. ruralhealthinfo.org ruralhealthinfo.org/project-examples/956

Project ENABLE (Educate, Nurture, Advise, Before Life Ends) Over 300 patients enrolled over 4 years: Half of the patients received ENABLE and half received usual cancer care. Family caregivers did not ...

4. bmcpalliatcare.biomedcentral.com bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-024-01353-2

ENABLE-SG (Educate, Nurture, Advise, Before Life Ends for ... The primary outcome is patient quality of life 6 months after baseline. Secondary patient-reported outcomes include mood, coping, palliative ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04318886

Lay Coach-Led Early Palliative Care for Underserved ... This proposed hybrid type I randomized effectiveness-implementation trial will determine whether ENABLE Cornerstone compared to usual care can improve ...

6. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/programDetails.do?programId=3590238

Project ENABLE II Designed to enhance the quality of life for individuals with a new diagnosis of advanced-stage or recurrent cancer.