Palliative Care
Conditions
Keywords
cancer
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.
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.
Interventions
BEHAVIORALIntervention (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.
Sponsors
Texas Tech University Health Sciences Center, El Paso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire - 9 (PHQ-9) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department Visits | six weeks after enrollment | Frequency of visits will be analyzed as an intent-to-treat analysis |
| Intensive Care Unit Admissions | six weeks after enrollment | Frequency of visits will be analyzed as an intent-to-treat analysis |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at an academic medical center between May 8, 2018 and August 15, 2019.
Pre-assignment details
Participant enrollment and randomization occured at the same time. There were no enrolled participants excluded from the study before assignment to groups.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 56 |
| 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. | 46 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 4 |
| Overall Study | Lost to Follow-up | 21 | 2 |
| Overall Study | Withdrawal by Subject | 9 | 0 |
Baseline characteristics
| Characteristic | Intervention (Promotora) | Self-Education (Control) | Total |
|---|---|---|---|
| Age, Continuous | 53.28 years STANDARD_DEVIATION 11.79 | 50.7 years STANDARD_DEVIATION 11.4 | 52.09 years STANDARD_DEVIATION 11.62 |
| Education College | 10 Participants | 3 Participants | 13 Participants |
| Education High School | 24 Participants | 26 Participants | 50 Participants |
| Education No Schooling | 2 Participants | 1 Participants | 3 Participants |
| Education Primary School | 10 Participants | 7 Participants | 17 Participants |
| Education University, College | 6 Participants | 6 Participants | 12 Participants |
| Education Vocational School | 4 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 56 Participants | 46 Participants | 102 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Divorced/ separated | 20 Participants | 8 Participants | 28 Participants |
| Marital Status Married | 25 Participants | 29 Participants | 54 Participants |
| Marital Status Single, never married | 11 Participants | 7 Participants | 18 Participants |
| Marital Status Widowed | 0 Participants | 2 Participants | 2 Participants |
| Pain Abdomen | 11 Participants | 11 Participants | 22 Participants |
| Pain Chest | 2 Participants | 4 Participants | 6 Participants |
| Pain Head | 2 Participants | 9 Participants | 11 Participants |
| Pain Knees | 10 Participants | 12 Participants | 22 Participants |
| Pain Lower Back | 9 Participants | 6 Participants | 15 Participants |
| Pain Neck | 5 Participants | 4 Participants | 9 Participants |
| Pain Upper Arms/ Shoulders | 6 Participants | 7 Participants | 13 Participants |
| Pain Upper Back | 7 Participants | 4 Participants | 11 Participants |
| Pain Wrist | 4 Participants | 7 Participants | 11 Participants |
| Region of Enrollment United States | 56 participants | 46 participants | 102 participants |
| Sex: Female, Male Female | 48 Participants | 10 Participants | 58 Participants |
| Sex: Female, Male Male | 8 Participants | 36 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 56 | 4 / 46 |
| other Total, other adverse events | 27 / 56 | 21 / 46 |
| serious Total, serious adverse events | 2 / 56 | 1 / 46 |
Outcome results
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.
Time frame: The FACIT-Pal was administered at baseline and then again about six weeks later when study participation is completed.
Population: Data was only analyzed for participants who completed both the survey at both timepoints (baseline and completion).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (Promotora) | Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) | Study Completion | 134.04 score on a scale | Standard Deviation 45.65 |
| Intervention (Promotora) | Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) | Baseline | 138.93 score on a scale | Standard Deviation 22.95 |
| Self-Education (Control) | Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) | Baseline | 126.43 score on a scale | Standard Deviation 27.38 |
| Self-Education (Control) | Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal) | Study Completion | 119.17 score on a scale | Standard Deviation 40.39 |
p-value: 0.81two-sample independent t-test
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
Time frame: The PHQ-9 was administered at baseline and then again about six weeks later when study participation is completed..
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention (Promotora) | Patient Health Questionnaire - 9 (PHQ-9) | Baseline | 5.23 score on a scale | Standard Deviation 4.7 |
| Intervention (Promotora) | Patient Health Questionnaire - 9 (PHQ-9) | Study Completion | 6.77 score on a scale | Standard Deviation 6.84 |
| Self-Education (Control) | Patient Health Questionnaire - 9 (PHQ-9) | Baseline | 8.83 score on a scale | Standard Deviation 6.72 |
| Self-Education (Control) | Patient Health Questionnaire - 9 (PHQ-9) | Study Completion | 7 score on a scale | Standard Deviation 5.89 |
p-value: 0.09two-sample independent t-test
Secondary
Emergency Department Visits
Frequency of visits will be analyzed as an intent-to-treat analysis
Time frame: six weeks after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (Promotora) | Emergency Department Visits | 1.05 visits | Standard Deviation 1.73 |
| Self-Education (Control) | Emergency Department Visits | 1.39 visits | Standard Deviation 1.74 |
p-value: 0.33t-test, 2 sided
Secondary
Intensive Care Unit Admissions
Frequency of visits will be analyzed as an intent-to-treat analysis
Time frame: six weeks after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention (Promotora) | Intensive Care Unit Admissions | 2 Participants |
| Self-Education (Control) | Intensive Care Unit Admissions | 1 Participants |
p-value: 1Fisher Exact