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

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ClinicalTrials.gov Identifier: NCT03736031
Recruitment Status : Completed
First Posted : November 8, 2018
Results First Posted : October 26, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center, El Paso

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.

Condition or disease Intervention/treatment Phase
Palliative Care Behavioral: Intervention (Promotora) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: With Love: Using Promotoras for a Hispanic Community Palliative Care Intervention - A Pilot Study (Promotora Palliative)
Actual Study Start Date : May 8, 2018
Actual Primary Completion Date : October 4, 2019
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: Intervention (Promotora)
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)
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.

No Intervention: Self-Education (Control)
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736031


Locations
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United States, Texas
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
Investigators
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Study Director: Christina Bracamontes, MS Texas Tech University HSC El Paso
  Study Documents (Full-Text)

Documents provided by Texas Tech University Health Sciences Center, El Paso:
Study Protocol  [PDF] March 28, 2019
Informed Consent Form  [PDF] October 16, 2018
Statistical Analysis Plan  [PDF] March 28, 2019

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Responsible Party: Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT03736031    
Other Study ID Numbers: E18031
First Posted: November 8, 2018    Key Record Dates
Results First Posted: October 26, 2020
Last Update Posted: October 26, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Texas Tech University Health Sciences Center, El Paso:
cancer