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Completed

NCT Number: NCT03736031

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

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.

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Key information

Conditions

Palliative Care Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University Health Sciences Center El Paso

El Paso, Texas, 79905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention (Promotora)

Behavioral

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.

Primary outcomes

  1. Patient Health Questionnaire - 9 (PHQ-9)

    Time frame: The PHQ-9 was administered at baseline and then again about six weeks later when study participation is completed..

    Patient Health Questionnaire -9 (PHQ-9); the score can range from 0 - 27; the lower score indicates a better outcome

  2. Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal)

    Time frame: The FACIT-Pal was administered at baseline and then again about six weeks later when study participation is completed.

    Functional Assessment Chronic Illness Therapy (FACIT)-Palliative care (Pal), score range 0-184, a higher score means a better outcome.

Secondary outcomes

  1. Emergency Department Visits

    Time frame: six weeks after enrollment

    Frequency of visits will be analyzed as an intent-to-treat analysis

  2. Intensive Care Unit Admissions

    Time frame: six weeks after enrollment

    Frequency of visits will be analyzed as an intent-to-treat analysis

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center, El Paso

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 8, 2018
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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