Trial Outcomes & Findings for With Love: Using Promotoras for a Hispanic Community Palliative Care Promotora Palliative Care (NCT NCT03736031)
NCT ID: NCT03736031
Last Updated: 2020-10-26
Results Overview
Patient Health Questionnaire -9 (PHQ-9); the score can range from 0 - 27; the lower score indicates a better outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
The PHQ-9 was administered at baseline and then again about six weeks later when study participation is completed..
Results posted on
2020-10-26
Participant Flow
Participants were enrolled at an academic medical center between May 8, 2018 and August 15, 2019.
Participant enrollment and randomization occured at the same time. There were no enrolled participants excluded from the study before assignment to groups.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
46
|
|
Overall Study
COMPLETED
|
24
|
40
|
|
Overall Study
NOT COMPLETED
|
32
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
21
|
2
|
|
Overall Study
Withdrawal by Subject
|
9
|
0
|
Baseline Characteristics
All questions were voluntary. If a participant refused to answer, they were able to skip the question.
Baseline characteristics by cohort
| Measure |
Intervention (Promotora)
n=56 Participants
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.
|
Self-Education (Control)
n=46 Participants
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.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.28 years
STANDARD_DEVIATION 11.79 • n=56 Participants
|
50.7 years
STANDARD_DEVIATION 11.4 • n=46 Participants
|
52.09 years
STANDARD_DEVIATION 11.62 • n=102 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=56 Participants
|
10 Participants
n=46 Participants
|
58 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=56 Participants
|
36 Participants
n=46 Participants
|
44 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
56 Participants
n=56 Participants
|
46 Participants
n=46 Participants
|
102 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=56 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=102 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=56 Participants
|
46 participants
n=46 Participants
|
102 participants
n=102 Participants
|
|
Education
No Schooling
|
2 Participants
n=56 Participants
|
1 Participants
n=46 Participants
|
3 Participants
n=102 Participants
|
|
Education
Primary School
|
10 Participants
n=56 Participants
|
7 Participants
n=46 Participants
|
17 Participants
n=102 Participants
|
|
Education
High School
|
24 Participants
n=56 Participants
|
26 Participants
n=46 Participants
|
50 Participants
n=102 Participants
|
|
Education
College
|
10 Participants
n=56 Participants
|
3 Participants
n=46 Participants
|
13 Participants
n=102 Participants
|
|
Education
Vocational School
|
4 Participants
n=56 Participants
|
3 Participants
n=46 Participants
|
7 Participants
n=102 Participants
|
|
Education
University, College
|
6 Participants
n=56 Participants
|
6 Participants
n=46 Participants
|
12 Participants
n=102 Participants
|
|
Marital Status
Married
|
25 Participants
n=56 Participants
|
29 Participants
n=46 Participants
|
54 Participants
n=102 Participants
|
|
Marital Status
Single, never married
|
11 Participants
n=56 Participants
|
7 Participants
n=46 Participants
|
18 Participants
n=102 Participants
|
|
Marital Status
Divorced/ separated
|
20 Participants
n=56 Participants
|
8 Participants
n=46 Participants
|
28 Participants
n=102 Participants
|
|
Marital Status
Widowed
|
0 Participants
n=56 Participants
|
2 Participants
n=46 Participants
|
2 Participants
n=102 Participants
|
|
Pain
Head
|
2 Participants
n=50 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
9 Participants
n=45 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
11 Participants
n=95 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
|
Pain
Chest
|
2 Participants
n=49 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
4 Participants
n=45 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
6 Participants
n=94 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
|
Pain
Abdomen
|
11 Participants
n=50 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
11 Participants
n=45 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
22 Participants
n=95 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
|
Pain
Wrist
|
4 Participants
n=50 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
7 Participants
n=46 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
11 Participants
n=96 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
|
Pain
Knees
|
10 Participants
n=50 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
12 Participants
n=45 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
22 Participants
n=95 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
|
Pain
Neck
|
5 Participants
n=50 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
4 Participants
n=45 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
9 Participants
n=95 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
|
Pain
Upper Back
|
7 Participants
n=50 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
4 Participants
n=45 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
11 Participants
n=95 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
|
Pain
Lower Back
|
9 Participants
n=50 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
6 Participants
n=45 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
15 Participants
n=95 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
|
Pain
Upper Arms/ Shoulders
|
6 Participants
n=51 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
7 Participants
n=45 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
13 Participants
n=96 Participants • All questions were voluntary. If a participant refused to answer, they were able to skip the question.
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Intervention (Promotora)
n=26 Participants
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.
|
Self-Education (Control)
n=41 Participants
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.
|
|---|---|---|
|
Patient Health Questionnaire - 9 (PHQ-9)
Baseline
|
5.23 score on a scale
Standard Deviation 4.7
|
8.83 score on a scale
Standard Deviation 6.72
|
|
Patient Health Questionnaire - 9 (PHQ-9)
Study Completion
|
6.77 score on a scale
Standard Deviation 6.84
|
7 score on a scale
Standard Deviation 5.89
|
PRIMARY outcome
Timeframe: 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).
Functional Assessment Chronic Illness Therapy (FACIT)-Palliative care (Pal), score range 0-184, a higher score means a better outcome.
Outcome measures
| Measure |
Intervention (Promotora)
n=26 Participants
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.
|
Self-Education (Control)
n=41 Participants
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.
|
|---|---|---|
|
Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal)
Baseline
|
138.93 score on a scale
Standard Deviation 22.95
|
126.43 score on a scale
Standard Deviation 27.38
|
|
Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal)
Study Completion
|
134.04 score on a scale
Standard Deviation 45.65
|
119.17 score on a scale
Standard Deviation 40.39
|
SECONDARY outcome
Timeframe: six weeks after enrollmentFrequency of visits will be analyzed as an intent-to-treat analysis
Outcome measures
| Measure |
Intervention (Promotora)
n=56 Participants
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.
|
Self-Education (Control)
n=46 Participants
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.
|
|---|---|---|
|
Emergency Department Visits
|
1.05 visits
Standard Deviation 1.73
|
1.39 visits
Standard Deviation 1.74
|
SECONDARY outcome
Timeframe: six weeks after enrollmentFrequency of visits will be analyzed as an intent-to-treat analysis
Outcome measures
| Measure |
Intervention (Promotora)
n=56 Participants
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.
|
Self-Education (Control)
n=46 Participants
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.
|
|---|---|---|
|
Intensive Care Unit Admissions
|
2 Participants
|
1 Participants
|
Adverse Events
Intervention (Promotora)
Serious events: 2 serious events
Other events: 27 other events
Deaths: 2 deaths
Self-Education (Control)
Serious events: 1 serious events
Other events: 21 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Intervention (Promotora)
n=56 participants at risk
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.
|
Self-Education (Control)
n=46 participants at risk
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.
|
|---|---|---|
|
General disorders
Hospital admission
|
3.6%
2/56 • 1 year
|
2.2%
1/46 • 1 year
|
Other adverse events
| Measure |
Intervention (Promotora)
n=56 participants at risk
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.
|
Self-Education (Control)
n=46 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
14/56 • 1 year
|
19.6%
9/46 • 1 year
|
|
General disorders
Pain
|
17.9%
10/56 • 1 year
|
19.6%
9/46 • 1 year
|
|
Blood and lymphatic system disorders
Swelling
|
5.4%
3/56 • 1 year
|
6.5%
3/46 • 1 year
|
Additional Information
Associate Director of Ob/Gyn Research
Texas Tech University Health Sciences Center at El Paso
Phone: 915-215-5103
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place