Palliative CareNCT03736031
With Love: Using Promotoras for a Hispanic Community Palliative Care Promotora Palliative Care
A study testing Intervention (Promotora) in people with Palliative Care, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Palliative Care
- What is being tested?
- Intervention (Promotora)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Under 17 years of age
- Not Hispanic
- Is not a patient of UMC or TTUHSC El Paso
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, 79905
About this study
Official title: With Love: Using Promotoras for a Hispanic Community Palliative Care Intervention - A Pilot Study (Promotora Palliative)
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.
Read the 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.
- Conditions
- Palliative Care
- Being tested
- Intervention (Promotora)
- Keywords
- cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention (Promotora)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Frequency of visits will be analyzed as an intent-to-treat analysis
Measured: six weeks after enrollment
Intensive Care Unit Admissions
Frequency of visits will be analyzed as an intent-to-treat analysis
Measured: six weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start8 May 2018
- Primary completion4 Oct 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Bracamontes, MS, Study director, Texas Tech University HSC El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736031
- Sponsor's protocol ID
- E18031
- Status last verified
- Oct 2020
- First submitted
- 4 Apr 2018
- Last updated
- 26 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- With Love: Using Promotoras for a Hispanic Community Palliative Care Intervention - A Pilot Study (Promotora Palliative)
- ClinicalTrials.gov ID
- NCT03736031
- Acronym / sponsor ID
- E18031
- Conditions
- Palliative Care
- Keywords
- cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- 8 May 2018 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Posted 26 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Promotora) | Experimental | Behavioral: 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. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Under 17 years of age
- Not Hispanic
- Is not a patient of UMC or TTUHSC El Paso
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention (Promotora) |
Primary outcome
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
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.
2 secondary outcomes
Emergency Department Visits
Time frame: six weeks after enrollment
Intensive Care Unit Admissions
Time frame: six weeks after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Bracamontes, MS study director
Texas Tech University HSC El Paso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention (Promotora) in people with Palliative Care, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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..). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020; AzTrials last refreshed its copy on 6 Nov 2026.