Clinical trial NCT03736031: With Love: Using Promotoras for a Hispanic Community Palliative Care Promotora Palliative Care
Official title: With Love: Using Promotoras for a Hispanic Community Palliative Care Intervention - A Pilot Study (Promotora Palliative)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: cancer
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: The PHQ-9 was administered at baseline and then again about six weeks later when study participation is completed..
measure: Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal)
timeFrame: The FACIT-Pal was administered at baseline and then again about six weeks later when study participation is completed.
Secondary outcomes:
measure: Emergency Department Visits
timeFrame: six weeks after enrollment
measure: Intensive Care Unit Admissions
timeFrame: six weeks after enrollment
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center El Paso
state: Texas
Study officials:
affiliation: Texas Tech University HSC El Paso
name: Christina Bracamontes, MS
role: STUDY_DIRECTOR
References: