Community Health Worker Based Intervention to Improve Palliative Care

Not Applicable

• Conditions: Advanced Cancer; Cancer; Malignancy; End Stage Cancer
• Interventions: Other: Community Health Worker (CHW) based palliative care

• Registration Number: NCT05407844
• Lead Sponsor: Johns Hopkins University

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.

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 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 Timeline

• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-02
• Study First Posted: 2022-06-07
• Status Verified: 2023-11
• Study Start: 2023-11-02
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-08
• Primary Completion: 2027-06-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 310

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

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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)
• >18 years old
• English speaking
• Intact cognition and ability to provide informed consent

Caregiver Exclusion Criteria:

• Participants < 18 years of age

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care + DeCIDE PC intervention	Community Health Worker (CHW) based palliative care	Community health worker support and standard cancer care

Primary Outcome Measures

Name	Time	Method
Number of participants who completed Advance Directives	6 months after enrollment	Advanced care planning

Secondary Outcome Measures

Name	Time	Method
Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) score	6 months after enrollment	Quality of Life; Score range: 0-184 \[per scoring document, for total score\] Higher scores signify better quality of life
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)	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.
Goals of care as assessed by Quality of communication (QOC) scale	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
Symptom Intensity as assessed by the Edmonton Symptom Assessment Score (ESAS)	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)
Number of participants who utilize hospice care	6 months after enrollment	Hospice care utilization within 14 days of death (Yes/No)

Trial Locations

Locations (1)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States