With Love: Using Promotoras for a Hispanic Community Palliative Care Intervention - A Pilot Study (Promotora Palliative)
Phase: NA
Conditions: Palliative Care
Sponsor: Texas Tech University Health Sciences Center, El Paso

With Love: Using 
Promotoras for a 
Hispanic Community 
Palliative Care 
Promotora Palliative 
Care 
 
NCT03736031 
 
March 28, 2019 

Title: Con cariño: Using Promotoras for a Hispanic Community Palliative Care 
Intervention – A pilot study 
 
Objective/Hypothesis: We hypothesize that the intervention group (promotora-based) 
will, in comparison to a self-education group (no promotora), show improved quality of 
life and pain scores and decreased ED visits and ICU admissions. We anticipate that 
the promotora-based program will be cost-effective.  
 
Specific Aims: (1) To assess the impact of the promotora-based program compared to 
self-education (usual care) on quality of life scores, pain scores, ED visits, and ICU 
admissions as assessed via survey completion and the medical record. (2) To perform a 
cost-effectiveness analysis of this intervention. (3) To utilize our findings to establish a 
novel, culturally sensitive, outpatient, cancer palliative care program in an underserved, 
majority Latino, county hospital setting. 
 
Goals of the Research: We anticipate our intervention will increase the rate of 
palliative care service utilization among underserved Latino cancer patients residing on 
the US-Mexico border. We believe that by increasing the awareness of palliative care 
services that there will be a decrease in overall health care costs as well as an overall 
improvement in quality of life for the Hispanic cancer patients in our community. 
 
 
Background and Significance: Palliative care is defined as “care given to improve the 
quality of life of patients who have a serious or life-threatening disease”. The integration 
of palliative care early in the treatment course of advanced cancer patients has been 
shown to improve quality of life, increase survival among cancer patients, and decrease 
overall healthcare costs. (Hay et al., 2017, Temel et al., 2010). Access to end of life 
care; however, is not equal with significant disparities occurring among minorities and 
marginalized groups.  
 
A study involving patients with gynecological cancers found that non-white patients 
were less likely to enroll in hospice or palliative care despite a majority reporting wishing 
to die pain free and comfortable in their homes (Harris et al., 2009). Latinos are also 
less likely to have had end of life conversations with health care providers and may 
therefore be less informed regarding end of life issues such as advance directives. This 
is despite studies showing that end of life conversations improve advance care planning 
among Latinos (Shen et al., 2016). 
 
End of life costs are a great burden for many Latinos. Up to 25% or more of healthcare 
costs are amounted in a patient’s last year of life, making end of life care especially 
difficult for this group and others of low socioeconomic status (Riley & Lubitz, 2010). In 
a study by Hanchate et al., it was found that Latinos’ Medicare expenditures are 57% 
higher than Whites in their last six months of life ($21,166 vs $31,702 even with 
controlling for sex, age, morbidity-burden level, cause and site of death) (Hanchate, 
Kronman, Young-Xu, Ash, & Emmanuel, 2009). A lack of insurance and immigration 
status increases this burden. Currently there are 11.1 million undocumented immigrants 

in the US which account for 14.6% of the uninsured population. These individuals rarely 
have access to appropriate end of life care due to costs (Jaramillo & Hui, 2016). Along 
the US-Mexico border these figures are exponentially increased. In 2008, prior to the 
Affordable Care Act, nearly half of the US residents living along the Mexico-US border 
had no health insurance and about 63% of the uninsured were undocumented foreign-
born individuals (Su, Pratt, Stimpson, Wong, & Pagán, 2014). The uninsured rate 
decreased to 31% by 2012 among residents living in the US-Mexico border region; yet 
the majority remained unable to access health care (Shen, M., Gai, Y., & Feng, 2016). 
 
The lack of insurance, increased cancer-care burden, and cultural barriers are leaving 
many dying Latinos and their families vulnerable at one of the most difficult times. It is 
imperative that innovative approaches are considered to provide the best care at the 
end of life. Moreover, this could potentially decrease costs to Medicare and hospitals.  
      
Our aim is to test the cost effectiveness with respect to the healthcare system with an 
innovative approach for palliative care education intended to increase the quality of care 
at the end of life for Latinos in a US-Mexico border town. Our goal is to use promotoras 
(community health workers) to provide palliative services to patients diagnosed with 
advanced cancer. This model has demonstrated success in other behavioral 
modification programs such as those designed to increase cervical cancer screening 
rates, increase vaccination uptake, and medication adherence. In a program using lay 
navigators among elderly oncology patients with Medicare it was estimated that a total 
of 19 million dollars in costs per year was eliminated among the navigated patients. ED 
visits decreased by 6% per quarter in navigated compared to non-navigated patients, 
ICU admissions were reduced by 10.6%; and lastly, the cost of using a navigator gave a 
return on investment of 1:10 (Rocque et al., 2017).  
      
We believe that we can use promotoras in the context of a culturally-sensitive palliative 
education program. We hypothesize that this intervention will decrease healthcare costs 
through a reduction in ED visits and ICU admissions. Additionally, we hypothesize that 
promotora-based education regarding self-care will reduce depression, improve pain 
control, and improve overall quality of care as perceived by patients and families in a 
Latino underserved community. 
 
 
Innovation:  
 
El Paso, a town in the US-Mexico border, is home to over 800,000 residents of which 
82% are Hispanic/Latino, almost a quarter of its population does not have health 
insurance and 20% lives below the federal poverty line. El Paso along with many other 
border towns suffers from an increasing burden due to health disparities and lack of 
health access. It is estimated that along the Texas-Mexico border there is 1 general 
practitioner for over 6,000 people and this number broadens for many specialties. 
Cancer is currently the second leading cause of death in El Paso and the majority of 
these patients do not receive comprehensive palliative care services. We believed that 
due to the high burden of cancer and cancer related deaths, it was imperative that 

palliative services will be offered to these patients. Due to the many barriers that 
currently exist to providing health care among Latinos in the US-Mexico border such as 
physician shortage and lack of insurance, a new innovative way to provide these 
services had to be implemented.  
 
Promotoras, or lay community health care workers, have been imperative in bridging the 
gap of health care access and disease prevention along the US-Mexico border. The 
promotora model has been used successfully for disseminating health information, 
improving cancer screening, vaccinations, and implementation of many public health 
projects. We believe that this model can also be applied to providing palliative care 
services and education. This has not been done before. We believe that this new 
approach will help to improve access in remote areas where access to health care is 
limited and simultaneously be cost effective. 
 
 
Research Design and Methods:  
 
Study Population: Our study population will include men and women with advanced 
cancer or with a new change in prognosis i.e. metastasis or recurrence of primary 
cancer and/or their caregivers. Participants must be over the age of 18 years and self-
identify as Hispanic or Latino. Each patient must be capable of providing consent to 
participate on the project. The subjects will be recruited from Texas Tech clinics as well 
as from University Medical Center where they will be invited to participate.  
 
Sample Size:  
Promotora study: A total of 150 patients will be recruited and will be randomly assigned 
to either the control or intervention groups.  
 
Caregiver study: A total of 150 caregivers will be recruited.  
 
Recruitment plan:  
Promotora study: 
• 
Each patient will be recruited via the Texas Tech clinics and the University 
Medical Center (UMC): palliative care service, the UMC cancer navigation 
program, and the infusion center. Each patient and their caregivers will be invited 
and those who desire to participate will be contacted by the research staff 
personnel. A screening survey will be done to see if they first qualify. Patients 
already enrolled in inpatient or outpatient hospice will be excluded. Interested 
and qualifying individuals will be consented by the research staff. At this time, the 
participant will also complete baseline surveys: Demographics, Patient Health 
Questionnaire-9 (PHQ-9), and Functional Assessment of Chronic Illness 
Therapy-Palliative Care (FACIT-Pal). Participants can choose whether to fill out 
the surveys on their own (self-administer) or have a research staff member read 
the questions and mark the answer choices on their behalf (structured 
interview).  
 

 
• 
Participants will be randomized into either the intervention (also known as the 
study group or the promotora) group or the control (also known as self-education 
or control) group. Each 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 (demographics, PHQ-9, FACIT-Pal), interim (adverse events) 
and exit (adverse events, PHQ-9, FACIT-Pal) surveys. Information pertaining to 
hospitalizations and emergency room visits will be obtained from their medical 
records and public health records. The intervention group will have three face-to-
face meetings with the promotora. The control group will receive two phone calls. 
 
• 
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. Participants will be encouraged to bring support persons to the 
promotora meetings.   
o Meeting 1 topic: What is cancer, Medical Management, What is palliative 
care, Local resources, Goals and Expectations, Discussion. Total time: 45 
min 
o Meeting 2 topic: Taking care of self: physical activity, nutrition, pain 
management, Family Values, Total: 50 min 
o Meeting 3 topic: Caregiver burnout, patient’s wishes, revisit Goals and 
Expectations. Making hard decisions, planning for the future (Power of 
Attorney, Advance Directives). Local resources, support groups, the 
grieving process. Exit interview (Re-administration of FACIT-Pal and PHQ-
9 and advanced directives) Total: 45 min 
 
At the beginning of each meeting the patients will be asked about adverse events 
(hospitalizations and ED visits). This data will be validated against the 
information stored within the patient’s medical record 
 
 If the patient is in the control group, they will receive two phone calls. The first 
phone call will be to ask about adverse events that have occurred since 
enrollment into the study. The second call will be to ask about adverse events 
since the first phone call and to administer the exit interview (Re-administration of 
FACIT-Pal and PHQ-9).  
 
Caregiver study: 
All patients recruited to the study will be asked to identify their caregiver to take the 
caregiver financial survey. The caregiver may be of any race or gender. If the caregiver 
is with the participant and if they would like to participate, they will be told the survey is 
completely confidential, voluntary, and they may refuse to answer any question that will 
make them feel uncomfortable. If the caregiver is not with the participant, we will give 
the participant a study flyer with research staff contact information. The study may be 
administered via phone, in person, or via email, based on the caregivers' preference. If 

the caregiver would like to participate, they will assigned a participant identification 
number which will be randomly assigned by REDCap.  
 
Texas Hospital Inpatient Discharge Public Use Data File (PUDF) analysis: Because 
both arms of the study technically had an intervention simply participating in the study 
may have also had an impact. A way to assess this would be to compare the rate of 
hospital events at the end of life to the rate observed in the study. A retrospective chart 
review of Texas Hospital Inpatient Discharge Public Use Data File (PUDF) will be 
conducted in which patients have the principal discharge diagnosis field contained an 
ICD-9 code for a malignant neoplasm (codes 140* through 208*, where the asterisk 
represents a wild card operator) and the patient was discharged to either hospice-home 
or hospice–medical facility. 
 
Incentives: 
Promotora study: Each participant will receive $70 for completion of the entire survey 
set: Participants in the study group will receive $25 at randomization, $10 at the first 
meeting with the promotora, $10 for the second meeting with the promotora, and $25 for 
the third meeting with the promotora. Participants in the control group will receive $25 at 
randomization, $15 will be mailed after the first phone interview, and $30 will be mailed 
to participant after second/final phone interview.   
 
 
Caregiver study: The caregiver will not receive an incentive. 
 
Challenges:  
We anticipate that a potential difficulty will be participant retention. Additionally, as we 
will be recruiting many patients at the end of life, we recognize that hospitalization and 
death may prevent study completion. As participants are individuals with advanced 
stage cancer, death is a likely occurrence in many cases and will not be considered an 
adverse or unexpected event. We will accommodate timing issues by providing the 
educational meetings every other week. The participants will also be compensated for 
their time. Additionally, we will enable in person collection of survey materials at the 
location of patients who are either hospitalized, become confined at home, or who 
transfer into inpatient hospice over the course of the study. As the participants will have 
complex medical issues, we will have the support of a gynecologic-oncologist and a 
medical oncologist for any emergent medical concerns that may arise until the patient 
may be seen by his or her treating oncologist. We anticipate that the study will take 1 
year to complete accrual, 18 months to complete data acquisition and an additional 4-6 
months for data analysis, interpretation and reporting. We strongly believe this project 
will lay the groundwork for a larger, comprehensive, and culturally sensitive palliative 
program that may be generalized to other centers to decrease the cancer care burden 
in the Hispanic community. 
 
 
Statistical Analysis:  

For the caregiver portion of the study, we are conducting a pilot study with a working 
number of 150 participants.  
 
For the patient portion of the study; a required sample size of 150 eligible patients was 
estimated based on a preliminary power calculation. It was determined with an alpha of 
.05 and power of 0.8 that a reduction of Emergency Department visits of 79%, 39 
patients per arm would be required, however, as the differences in the FACT-G will be 
more subtle, we would like to recruit 75 patients per arm.  
 
For the PUDF portion of the study, we will be reviewing 588 records. 
 
The data will be analyzed as an intent-to-treat analysis. Because of the multiplicity of 
Quality of Life (QoL) outcome measures and potential correlations among the scales, 
each QoL scale was tested at a significance level of .01 (.05/5) to control for the overall 
type I error at .05. As the overall measure of QoL was the Functional Assessment of 
Cancer Therapy scale –General (FACT-G), it will be considered the primary QoL 
outcome.  
 
We will be performing a standard cost-effectiveness analysis using TreeAge software.  
 
Tentative timeline: 
 
 
Program Development 
May-September 2017 
 
IRB/Funding 
October-November 2017 
 
Hiring/Training 
April 2018 
 
Rolling recruitment 
May 2018-January 2020 
 
Program Implementation 
May 2018- January 2020 
 
Interim Data analysis, 
Final data analysis 
November 2019 (Interim), 
January 2020 (Final) 
 
Program evaluation 
January-February 2020 
 
Written Paper/Poster 
presentation 
January-March 2019 
 
 
References: 
 
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Ethnic Difference in End-of-Life Costs: Why do Minorities Cost More Than 
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Harris, P. A., Taylor, R., Thielke, R., Payne, J., Gonzalez, N., & Conde, J. G. (2009). 
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Hay, C. M., Lefkowits, C., Crowley-Matoka, M., Bakitas, M. A., Clark, L. H., Duska, L. 
R., … Schenker, Y. (2017). Gynecologic Oncologist Views Influencing Referral to 
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Jaramillo, S., & Hui, D. (2016). End-of-Life Care for Undocumented Immigrants With 
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http://doi.org/10.1016/j.jpainsymman.2015.11.009  
 
Riley, G. F., & Lubitz, J. D. (2010). Long-term trends in medicare payments in the last 
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M. Y., … Oncology, A. S. of C. (2017). Resource Use and Medicare Costs During 
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