Community Health Worker Based Intervention to Improve Palliative Care

Study Overview
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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 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.

Official Title
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Community Health Worker Based Intervention to Improve Palliative Care

Conditions
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Cancer, End Stage Cancer, Malignancy, Advanced Cancer

Intervention / Treatment
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* Other: Community Health Worker (CHW) based palliative care


Participation Criteria
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Eligibility Criteria
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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 Patient 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>Standard cancer care | |
| Experimental: Standard care + DeCIDE PC intervention<br>Community health worker support and standard cancer care | Other: Community Health Worker (CHW) based palliative care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who completed Advance Directives | Advanced care planning | 6 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) score | Quality of Life; Score range: 0-184 [per scoring document, for total score] Higher scores signify better quality of life | 6 months after enrollment | 
| Number of participants who utilize hospice care | Hospice care utilization within 14 days of death (Yes/No) | 6 months after enrollment | 
| Goals of care as assessed by Quality of communication (QOC) scale | Goals of Care; Score range: 0-10 [scored 0-10 for each of 19 components] Higher scores signify: higher quality communication with physician | 6 months after enrollment | 
| Symptom Intensity as assessed by the Edmonton Symptom Assessment Score (ESAS) | Symptom; Score range: 0-10 [scored 0-10 for 10 components] Higher scores signify: higher intensity of cancer symptoms (worse symptoms) | 6 months after enrollment | 
| Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D) | 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. | 6 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palliative care, community health worker