Community Health Worker Based Intervention to Improve Palliative Care

NCT ID: NCT05407844

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-02

Study Completion Date

2027-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer End Stage Cancer Malignancy Advanced Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard care

Standard cancer care

Group Type NO_INTERVENTION

No interventions assigned to this group

Standard care + DeCIDE PC intervention

Community health worker support and standard cancer care

Group Type EXPERIMENTAL

Community Health Worker (CHW) based palliative care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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


* 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

Exclusion Criteria

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


* Participants \< 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabian M Johnston, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Aarti Mathur, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

TidalHealth Peninsula Regional, Inc.

Salisbury, Maryland, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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Johnston FM, Neiman JH, Parmley LE, Conca-Cheng A, Freund KM, Concannon TW, Smith TJ, Cooper LA. Stakeholder Perspectives on the Use of Community Health Workers To Improve Palliative Care Use by African Americans with Cancer. J Palliat Med. 2019 Mar;22(3):302-306. doi: 10.1089/jpm.2018.0366. Epub 2018 Nov 2.

Reference Type BACKGROUND
PMID: 30388060 (View on PubMed)

Monton O, Drabo EF, Masroor T, Fuller S, Woods AP, Siddiqi A, Malone TB, Johnston FM. Economic evaluation of a hybrid type 1 effectiveness-implementation trial comparing a community health worker palliative care intervention to enhanced standard of care in African American patients across four cancer centres in the USA: a study protocol. BMJ Open. 2025 Nov 4;15(11):e096402. doi: 10.1136/bmjopen-2024-096402.

Reference Type DERIVED
PMID: 41193212 (View on PubMed)

Siddiqi A, Monton O, Woods A, Masroor T, Fuller S, Owczarzak J, Yenokyan G, Cooper LA, Freund KM, Smith TJ, Kutner JS, Colborn KL, Joyner R, Elk R, Johnston FM. Dissemination and Implementation of a Community Health Worker Intervention for Disparities in Palliative Care (DeCIDE PC): a study protocol for a hybrid type 1 randomized controlled trial. BMC Palliat Care. 2023 Sep 18;22(1):139. doi: 10.1186/s12904-023-01250-0.

Reference Type DERIVED
PMID: 37718442 (View on PubMed)

Other Identifiers

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1R01CA252101-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01MD016935-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00283002

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00119097

Identifier Type: -

Identifier Source: org_study_id

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