Community Health Worker Based Intervention to Improve Palliative Care (DeCIDE PC)

April 23, 2026 updated by: Wake Forest University Health Sciences
The study aims to find out if community health worker (CHW) support will improve palliative care outcomes in African American patients with advanced cancer, by comparing the quality of life of patients who are receiving standard care to those whose standard care is supplemented with CHW support.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This research is being done to establish the effectiveness of a Community Health Worker based palliative care intervention among African American patients with advanced solid organ malignancies and their care givers.

The investigators' long-term goal is to reduce the research-to-practice gap in utilization of evidence-based palliative care (PC) in African Americans with advanced cancer. The objectives of this study are to establish the effectiveness of a CHW-based palliative care intervention and develop generalizable knowledge on how contextual factors influence implementation.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University School of Medicine
      • Salisbury, Maryland, United States, 21801
        • TidalHealth Peninsula Regional, Inc.
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Atrium Health Wake Forest Baptist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Patient Inclusion Criteria:

  • Self-identified African American patients with advanced (AJCC stage III or IV) solid organ malignancy
  • >=18 years old
  • English speaking
  • Intact cognition and ability to provide informed consent

Patient Exclusion Criteria:

  • Participants < 18 years of age
  • Participants who are already receiving palliative care services

Caregiver Inclusion Criteria:

  • Adult (>=18 years old) caregivers providing informal (unpaid) care to an eligible African American cancer patient (related or unrelated)
  • English speaking
  • Intact cognition and ability to provide informed consent

Caregiver Exclusion Criteria:

  • Participants < 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard care
Standard cancer care
Experimental: Standard care + DeCIDE PC intervention
Community health worker support and standard cancer care
Other: Community Health Worker (CHW) based palliative care
Those in the intervention group will receive support from a dedicated CHW trained in motivational interviewing, components of palliative care communication, and social determinants of health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who completed Advance Directives
Time Frame: 6 months after enrollment
Advanced care planning
6 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who utilize hospice care
Time Frame: 6 months after enrollment
Hospice care utilization within 14 days of death (Yes/No)
6 months after enrollment
Goals of care as assessed by Quality of communication (QOC) scale
Time Frame: 6 months after enrollment
Goals of Care; Score range: 0-10 [scored 0-10 for each of 19 components] Higher scores signify: higher quality communication with physician
6 months after enrollment
Symptom Intensity as assessed by the Edmonton Symptom Assessment Score (ESAS)
Time Frame: 6 months after enrollment
Symptom; Score range: 0-10 [scored 0-10 for 10 components] Higher scores signify: higher intensity of cancer symptoms (worse symptoms)
6 months after enrollment
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: 6 months after enrollment
Symptom; The score is the sum of the 20 questions. Possible range is 0-60. A score of 16 points or more is considered depressed.
6 months after enrollment
Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) score
Time Frame: 6 months after enrollment
Quality of Life; Score range: 0-184 [per scoring document, for total score] Higher scores signify better quality of life
6 months after enrollment
Quality of life assessed by the 5-Level EuroQol 5-Dimensional (EQ-5D-5L)
Time Frame: 6 months after enrollment
it assesses five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a visual analogue scale (VAS). Each dimension has five levels ranging from 1 (no problem) to 5 (extreme problem). Score range 0 to 100, higher score indicates better quality of life.
6 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Fabian M Johnston, MD, MHS, Atrium Health Wake Forest Baptist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

June 2, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00119097
  • IRB00283002 (Other Identifier: Johns Hopkins (old IRB #))
  • 1R01CA252101-01A1 (U.S. NIH Grant/Contract)
  • 1R01MD016935-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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