With Love: Using Promotoras for a Hispanic Community Palliative Care Promotora Palliative Care

Study Overview
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Brief Summary
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Despite being strongly recommended, the integration of palliative care in oncology has not been widely adopted. Very few people have access to comprehensive palliative care. Access is even lower in rural and Hispanic communities. Even in communities with access, uptake is often low due to a lack of education on the part of both patients and providers regarding palliative care. This study aims to use an innovative approach to provide quality palliative care to oncology Hispanic patients by using community health workers also known as promotoras.

Detailed Description
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Palliative care has been highly recommended to be an integral part of oncology yet very few people have access to comprehensive palliative care. Access is even lower in rural, low socio-economic and Hispanic communities. Palliative care has been shown to decrease healthcare costs. This study will use an innovative approach to provide quality palliative care to gynecology-oncology Hispanic patients by using community health workers also known as promotoras. The promotora model has been shown to be successful in several behavioral modification programs. The investigators aim to use promotoras to deliver a comprehensive and culturally sensitive educational intervention that covers self-care in the presence of cancer, advance directives, pain management, and care taker awareness. The goal of the intervention will be to decrease number of emergency department visits and hospital admissions of patients with advanced cancer, and increase the rate of completion of advanced directives, as well as improve overall quality of life (as measured by standardized scales) when comparing the intervention group vs. the control (usual care) group. The investigators will additionally assess the cost effectiveness of this intervention.

Official Title
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With Love: Using Promotoras for a Hispanic Community Palliative Care Intervention - A Pilot Study (Promotora Palliative)

Conditions
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Palliative Care

Intervention / Treatment
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* Behavioral: Intervention (Promotora)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be 18 years or older Must be a Texas Tech University Health Sciences Center El Paso (TTUHSC El Paso) or University Medical Center (UMC) El Paso patient Must be Hispanic Must have a cancer diagnosis Exclusion Criteria: Under 17 years of age Not Hispanic Is not a patient of UMC or TTUHSC El Paso

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (Promotora)<br>The intervention group will have three face-to-face meetings with the promotora. Participant will continue to receive the standard of care for his or her oncologic diagnosis as determined by his or her treating oncologist over the course of the study. During the study period, all participants will complete baseline, interim and exit surveys covering demographics, quality of life and pain management. Information pertaining to hospitalizations and emergency room visits will be obtained from their medical records and public health records. | Behavioral: Intervention (Promotora)<br>* If the patient is in the intervention group, the promotora will call the patient in order to invite them to a meeting. Meetings will be arranged by the promotora and the patients. A total of 2 group meetings will be required by all participants and 1 family meeting.<br>|
| No Intervention: Self-Education (Control)<br>Participant will receive the standard of care for his or her oncologic diagnosis as determined by his or her treating oncologist over the course of the study. During the study period, all participants will complete baseline, interim and exit surveys covering demographics, quality of life and pain management. Information pertaining to hospitalizations and emergency room visits will be obtained from their medical records and public health records. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire - 9 (PHQ-9) | Patient Health Questionnaire -9 (PHQ-9); the score can range from 0 - 27; the lower score indicates a better outcome | The PHQ-9 was administered at baseline and then again about six weeks later when study participation is completed.. | 
| Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) | Functional Assessment Chronic Illness Therapy (FACIT)-Palliative care (Pal), score range 0-184, a higher score means a better outcome. | The FACIT-Pal was administered at baseline and then again about six weeks later when study participation is completed. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency Department Visits | Frequency of visits will be analyzed as an intent-to-treat analysis | six weeks after enrollment | 
| Intensive Care Unit Admissions | Frequency of visits will be analyzed as an intent-to-treat analysis | six weeks after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer