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Clinical Trials/NCT05407844
NCT05407844
Enrolling By Invitation
Not Applicable

Community Health Worker Based Intervention to Improve Palliative Care

Wake Forest University Health Sciences6 sites in 1 country160 target enrollmentNovember 2, 2023

Overview

Phase
Not Applicable
Intervention
Standard care
Conditions
Cancer
Sponsor
Wake Forest University Health Sciences
Enrollment
160
Locations
6
Primary Endpoint
Number of participants who completed Advance Directives
Status
Enrolling By Invitation
Last Updated
8 days ago

Overview

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 (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.

Registry
clinicaltrials.gov
Start Date
November 2, 2023
End Date
September 1, 2027
Last Updated
8 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

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

Arms & Interventions

Standard care

Standard cancer care

Standard care + DeCIDE PC intervention

Community health worker support and standard cancer care

Intervention: Community Health Worker (CHW) based palliative care

Outcomes

Primary Outcomes

Number of participants who completed Advance Directives

Time Frame: 6 months after enrollment

Advanced care planning

Secondary Outcomes

  • 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)
  • Quality of life assessed by the 5-Level EuroQol 5-Dimensional (EQ-5D-5L)(6 months after enrollment)

Study Sites (6)

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