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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency Department Visits | Frequency of visits will be analyzed as an intent-to-treat analysis | six weeks after enrollment |
| Intensive Care Unit Admissions | Frequency of visits will be analyzed as an intent-to-treat analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Bracamontes, MS | Texas Tech University HSC El Paso | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Tech University Health Sciences Center El Paso | El Paso | Texas | 79905 | United States |
Participant enrollment and randomization occured at the same time. There were no enrolled participants excluded from the study before assignment to groups.
Participants were enrolled at an academic medical center between May 8, 2018 and August 15, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | The PHQ-9 was administered at baseline and then again about six weeks later when study participation is completed.. |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital admission | General disorders | Systematic Assessment | This event was not related to the intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | This event was not related to the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director of Ob/Gyn Research | Texas Tech University Health Sciences Center at El Paso | 915-215-5103 | elp-obgynresearch@ttuhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 28, 2019 | Jul 9, 2020 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 16, 2018 | Jul 9, 2020 | ICF_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2019 | Sep 30, 2020 | SAP_004.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| six weeks after enrollment |
| Withdrawal by Subject |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Education | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Pain | All questions were voluntary. If a participant refused to answer, they were able to skip the question. | Count of Participants | Participants |
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| OG001 | 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. |
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|
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| Primary | 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. | Data was only analyzed for participants who completed both the survey at both timepoints (baseline and completion). | Posted | Mean | Standard Deviation | score on a scale | The FACIT-Pal was administered at baseline and then again about six weeks later when study participation is completed. |
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| Secondary | Emergency Department Visits | Frequency of visits will be analyzed as an intent-to-treat analysis | Posted | Mean | Standard Deviation | visits | six weeks after enrollment |
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| Secondary | Intensive Care Unit Admissions | Frequency of visits will be analyzed as an intent-to-treat analysis | Posted | Count of Participants | Participants | six weeks after enrollment |
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|
|
|
| 2 |
| 56 |
| 2 |
| 56 |
| 27 |
| 56 |
| EG001 | 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. | 4 | 46 | 1 | 46 | 21 | 46 |
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| Pain | General disorders | Systematic Assessment | This event was not related to the intervention. |
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| Swelling | Blood and lymphatic system disorders | Systematic Assessment | This event was not related to the intervention. |
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| Unknown or Not Reported |
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