Can a lay coach ease the burden for cancer caregivers?
NCT ID NCT04318886
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
- Can a video game teach cancer patients to tame their pain?
- Real-World melanoma care under the microscope
- Can a single psychedelic dose ease despair in advanced cancer?
- Do ICU family meetings for the very old vary across europe?
- Can tracking symptoms improve care for children with advanced cancer?
- Can a new pill boost Immunotherapy's power against advanced tumors?