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Lay Coach-Led Palliative Care for Cancer

Phase 3

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 weeks

Awards & highlights

Study Summary

This trial is testing 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. The goal is to improve family caregiver and patient outcomes, and to evaluate implementation costs, cost effectiveness and healthcare utilization.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since ENABLE Cornerstone is a non-medical intervention focusing on education and support rather than medication or medical procedures, there are no direct physical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I speak English and can complete initial health assessments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Distress (Family Caregiver)

Secondary outcome measures

Burden (Family Caregiver)

Distress (Patient)

Healthcare Utilization (Patient)

+2 more

Other outcome measures

Implementation costs and cost effectiveness

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Project ENABLE CornerstoneExperimental Treatment1 Intervention

Group II: Usual CareActive Control1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,280,766 Total Patients Enrolled

University of South AlabamaOTHER

42 Previous Clinical Trials

15,346 Total Patients Enrolled

Media Library

ENABLE Cornerstone Clinical Trial Eligibility Overview. Trial Name: NCT04318886 — Phase 3

Cancer Research Study Groups: Usual Care, Project ENABLE Cornerstone

Cancer Clinical Trial 2023: ENABLE Cornerstone Highlights & Side Effects. Trial Name: NCT04318886 — Phase 3

ENABLE Cornerstone 2023 Treatment Timeline for Medical Study. Trial Name: NCT04318886 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are volunteers for this clinical trial?

"That is correct, the online clinicaltrials.gov registry reflects that this study is open and recruiting patients. 588 individuals are needed for the trial at a single site; this research was first made public on January 7th, 2020 with December 4th, 2021 being the most recent update."

Answered by AI

Are there any risks associated with ENABLE Cornerstone?

"ENABLE Cornerstone received a score of 3 from our team at Power. This is because it is a Phase 3 trial, meaning that there is both some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Are researchers presently looking for new participants for this trial?

"The trial is open for recruitment, as indicated by clinicaltrials.gov. This information was last updated on December 4th, 2021, after the study's initial posting on January 7th, 2020."

Answered by AI

Recent research and studies

TrialsJournal

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, Avery C., Andres Azuero, Maria Pisu, Jennifer Young Pierce, Grant R. Williams, Richard A. Taylor, Rachel Wells, et al.. 2022. “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”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-022-06305-w.

clinicaltrials.govStudy

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

James N Dionne-Odom 2020. "Lay Coach-Led Early Palliative Care for Underserved Advanced Cancer Caregivers: The Project ENABLE Cornerstone RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04318886.