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

NCT03736031 | Completed Results

• 1 other identifier: E18031
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Palliative Care

Keywords

cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Emergency Department Visits

  six weeks after enrollment

• Intensive Care Unit Admissions

  six weeks after enrollment

Study Arms (2)

Intervention (Promotora)

EXPERIMENTAL

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)

Self-Education (Control)

NO INTERVENTION

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.

Interventions

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.

Intervention (Promotora)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under 17 years of age
• Not Hispanic
• Is not a patient of UMC or TTUHSC El Paso

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

Texas Tech University Health Sciences Center El Paso

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Associate Director of Ob/Gyn Research
• Organization: Texas Tech University Health Sciences Center at El Paso

elp-obgynresearch@ttuhsc.edu

915-215-5103

Study Officials

• Christina Bracamontes, MS

  Texas Tech University HSC El Paso

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: November 8, 2018
• Study Start: May 8, 2018
• Primary Completion: October 4, 2019
• Study Completion: June 30, 2020
• Last Updated: October 26, 2020
• Results First Posted: October 26, 2020

Record last verified: 2020-10

Locations

US (1)