Table 2 World Health Organization Trial Registration Data Set (Version 1.3.1)

Primary Registry and Trial Identifying Number

Registered on ClinicalTrials.gov, NCT05407844

Date of Registration in Primary Registry

First posted on June 7, 2022

Secondary Identifying Numbers

Not applicable

Source(s) of Monetary or Material Support

This study is funded by the National Cancer Institute (NCI)

Grant number: 1R01CA252101-01A1

Primary Sponsor

The study sponsor is Johns Hopkins University

Secondary Sponsor(s)

Not applicable

Contact for Public Queries

OM (omonton1@jh.edu)

TM (tmasroo1@jh.edu)

Contact for Scientific Queries

FJ (fjohnst4@jhmi.edu)

Public Title

Community Health Worker Intervention for Disparities in Palliative Care (DeCIDE PC)

Scientific Title

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

Countries of Recruitment

United States

Health Condition(s) or Problem(s) Studied

Disparities in the access to and utilization of palliative care among African American patients with advanced solid organ malignancy

Intervention(s)

Intervention group: Community Health Worker Intervention for Disparities in Palliative Care (DeCIDE PC); theory-driven, stakeholder-informed palliative care intervention, which utilizes CHWs as care team members to enhance the receipt of palliative care for African Americans with advanced cancer

Comparator group: Enhanced standard of care; standard of care and a palliative care brochure

Key Inclusion and Exclusion Criteria

Inclusion criteria for patients: Adult (≥ 18 years old) patients who (1) self-identify as African American, (2) have advanced solid organ malignancy (AJCC stage III or IV), (3) are English speaking, (4) have intact cognition and an ability to provide informed consent, and (5) have not had any palliative care experience within the last year

Exclusion criteria for patients include: (1) age < 18 years old, (2) unable to read or comprehend English, (3) unable to provide informed consent, and (4) palliative care experience within the last year

Inclusion criteria for caregivers: Adult (≥ 18 years old) caregivers who (1) provide informal (unpaid) care to an eligible African American cancer patient (related or unrelated), (2) are English speaking, and (3) have intact cognition and an ability to provide informed consent

Exclusion criteria for caregivers include: (1) age < 18 years old, (2) unable to read or comprehend English, and (3) unable to provide informed consent

Study Type

Type of study: Interventional

Study design: Multicenter, randomized, assessor-blind, parallel-groups, pragmatic, hybrid type 1 effectiveness-implementation trial involving patients from three oncology practices in the United States

Date of First Enrollment

September 2023 (anticipated)

Sample Size

Target sample size: 160 patient-caregiver dyads (total 320 participants)

Recruitment Status

Pending: Participants are not yet being recruited or enrolled at any site

Primary Outcome(s)

Outcome Name: Advance care planning

Metric/method of measurement: Self-reported or documented Advance Directive or a documented discussion of care preferences between the patient and caregiver or healthcare team

Timepoints: Baseline, 2 months, 6 months

Key Secondary Outcomes

Outcome Name: Quality of life

Metric/method of measurement: Quality of Life measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care

Timepoints: Baseline, 2 months, 6 months

Ethics Review

Status: Approved

Date of approval: March 31, 2022

Completion Date

Not applicable

Summary Results

Not applicable

IPD Sharing Statement

Plan to share IPD: Yes

Plan description: We plan to make the full protocol, deidentified participant-level data, and the statistical code available from the corresponding author on reasonable request