NCT05407844

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
16mo left

Started Nov 2023

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

4 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Nov 2023Sep 2027

First Submitted

Initial submission to the registry

June 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 2, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3.6 years

First QC Date

June 2, 2022

Last Update Submit

April 23, 2026

Conditions

Keywords

palliative carecommunity health worker

Outcome Measures

Primary Outcomes (1)

  • Number of participants who completed Advance Directives

    Advanced care planning

    6 months after enrollment

Secondary Outcomes (6)

  • Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) score

    6 months after enrollment

  • Number of participants who utilize hospice care

    6 months after enrollment

  • Goals of care as assessed by Quality of communication (QOC) scale

    6 months after enrollment

  • Symptom Intensity as assessed by the Edmonton Symptom Assessment Score (ESAS)

    6 months after enrollment

  • Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)

    6 months after enrollment

  • +1 more secondary outcomes

Study Arms (2)

Standard care

NO INTERVENTION

Standard cancer care

Standard care + DeCIDE PC intervention

EXPERIMENTAL

Community health worker support and standard cancer care

Other: Community Health Worker (CHW) based palliative care

Interventions

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.

Standard care + DeCIDE PC intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

TidalHealth Peninsula Regional, Inc.

Salisbury, Maryland, 21801, United States

Location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (3)

  • 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.

    PMID: 30388060BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Neoplasms

Interventions

Community Health Workers

Intervention Hierarchy (Ancestors)

Allied Health PersonnelHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Fabian M Johnston, MD, MHS

    Atrium Health Wake Forest Baptist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 7, 2022

Study Start

November 2, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations