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Can a lay coach ease the burden for cancer caregivers?

NCT ID NCT04318886

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This study tests a program called ENABLE Cornerstone, where specially trained lay coaches provide support to family caregivers of people with advanced cancer. The coaches help caregivers manage stress, improve coping skills, and plan for the future through phone or in-person sessions. Researchers want to see if this reduces caregiver distress and improves quality of life compared to usual care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ENABLE Cornerstone (behavioral coaching program)
What this could lead to
If successful, this could provide a low-cost, scalable way to support caregivers of advanced cancer patients, reducing their distress and improving their quality of life.
What could go wrong
This is a behavioral intervention, so results may vary widely. The study focuses on a specific underserved population, so findings may not apply to all caregivers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

387 people

The number who actually took part.

Started

Jan 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Multi-Year Funded Merit Award - Years 6-7: Because this R37 extension study proposes long-term follow-up of existing and future parent trial participants, the eligibility criteria of FCGs and patients is the same as for the parent trial as listed below. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.