Assessing the Impact of a Community Health Worker on Hispanic Women's Reported Measures of Processes of Care in the Screening Mammography Setting
Phase: NA
Conditions: Breast Cancer, Screening Mammography, Community Health Worker
Sponsor: Vanderbilt University Medical Center

Promotora Navigator - Culturally Appropriate Patient Navigator
NCT03557801
June 6, 2018

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PROJECT TITLE: ........................................................................................................................................ 2 
BRIEF OVERVIEW/OBJECTIVES: ................................................................................................................ 2 
PROJECT PLAN: ........................................................................................................................................ 2 
Background: ......................................................................................................................................................................................................... 2 
Research Questions/Hypotheses: ................................................................................................................................................................ 3 
Methods: ................................................................................................................................................................................................................ 3 
Study Design: ........................................................................................................................................................................................................................... 3 
PN Identification and Education: .................................................................................................................................................................................... 3 
Inclusion/Exclusion Criteria: ........................................................................................................................................................................................... 3 
Recruitment: ............................................................................................................................................................................................................................ 4 
Hispanic Clinic Days: ............................................................................................................................................................................................................ 4 
Consent: ..................................................................................................................................................................................................................................... 5 
Baseline Assessment: ........................................................................................................................................................................................................... 5 
Randomization: ...................................................................................................................................................................................................................... 5 
Control Arm: ............................................................................................................................................................................................................................ 5 
Intervention Arm 1: .............................................................................................................................................................................................................. 5 
Intervention Arm 2: .............................................................................................................................................................................................................. 5 
Post Assessment 2-5 Days After Delivery of Results: ............................................................................................................................................ 5 
Delayed Chart Review: ........................................................................................................................................................................................................ 6 
Data Collection: ...................................................................................................................................................................................................................... 6 
Item Development: ............................................................................................................................................................................................................... 6 
Statistical Considerations: ................................................................................................................................................................................................. 6 
Sample Size: ............................................................................................................................................................................................................................. 6 
Anticipated Outcomes: ..................................................................................................................................................................................... 6 
Primary Outcome: ................................................................................................................................................................................................................. 6 
Secondary Outcome: ............................................................................................................................................................................................................ 7 
Timeline: ............................................................................................................................................................................................................... 7 
REFERENCES: ........................................................................................................................................... 7 
 
 
 

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Project Title: 
Impact of a Culturally Appropriate Patient Navigator (Promotora Navigator) on Trust and 
Communication in the Screening Mammography Setting 
 
Brief Overview/Objectives: 
 
1. To assess the relationship between level of trust in the healthcare system and active engagement in 
a mammography screening program in the local Hispanic population. 
2. To assess the relationship between health literacy and active engagement in a mammography 
screening program in the local Hispanic population. 
3. To determine whether a Promotora Navigator improves Hispanic women’s measures of trust in the 
healthcare system and provider compared to those receiving standard of care treatment in the 
screening mammography setting. 
4. To determine whether a Promotora Navigator improves Hispanic women’s measures of 
satisfaction with communication when compared to those receiving standard of care treatment in 
the screening mammography setting. 
Project Plan: 
Background: 
Although there has been interval improvement in reducing disparity in mammography utilization in 
medically underserved communities since the 1990s, significant disparities persist and should be 
addressed1.  Culturally adapted patient-targeted healthcare interventions can help reduce ethnic 
inequalities in access to cancer screening programs2.  “Promotoras”, culturally appropriate patient 
navigators have been shown to increase screening mammography rates in the Hispanic population3.  
However, there is little evidence on the impact of a Promotora Navigator (PN) program on patient 
trust in the healthcare system and satisfaction with communication in this setting.  This proposal aims 
to assess the impact of a PN on women’s trust in the healthcare system and satisfaction with 
communication when compared to those receiving standard of care.    
 
The study design is the final outcome of a Partnership Development Grant (PDG) awarded by the 
Meharry-Vanderbilt Community Engaged Research Core (CERC) to Dr. Lucy Spalluto of Vanderbilt 
University Medical Center and the Mid-South Division of the American Cancer Society.  This PDG 
provided an opportunity to engage numerous community stakeholders in collaboration.  The parent 
study was designed by both academic and community partners and then presented to a community 
engagement studio for refinement.  The final design outcome was submitted for and successfully 
awarded a CERC Community Engaged Research Grant.  Matthew Walker Comprehensive Health Center 
(MWCHC) will serve as a primary community partner moving forward, providing clinic facilities.  
MWCHC is an ideal community partner given the center’s proven record of providing healthcare 
services and health education to the local community, regardless of economic status. 
 

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As proposed, community partners benefit from education and potential development of a sustainable 
model for caring for women in developing minority groups.  The community will benefit from an 
increase in well woman screening provided to the local Hispanic population (including those in the 
control arm).  Academic partners will benefit from patient-centered outcomes data on the impact of 
the PN in the screening mammography setting. 
 
Research Questions/Hypotheses: 
Do trust in the healthcare system and/or health literacy impact engagement in a screening 
mammography program in the local Hispanic population?  We hypothesize that higher levels of trust 
and health literacy are positively related to engagement in a screening mammography program. 
 
Does a PN improve Hispanic women’s measures of trust in the healthcare system and satisfaction with 
communication in the screening mammography setting when compared to those receiving standard of 
care?  We hypothesize that women with access to a PN will have higher levels of trust in the healthcare 
system and satisfaction with communication than women receiving the standard of care. 
 
Methods: 
Study Design:  The study design is a randomized control trial.  In this pilot study, 100 participants will 
be randomized to either a) the intervention, in which they receive care from the PN or b) the control, 
in which they receive the standard of care.   
 
PN Identification and Education: 
A PN will be identified and trained by Claudia Barajas, VICC Community Health Educator.  Dr. Spalluto 
will supplement educational materials.   
 
Inclusion/Exclusion Criteria: 
Inclusion criteria will be Hispanic women meeting United States Preventive Services (USPSTF) criteria 
for screening mammography and criteria for clinical service coverage through the TN Breast and 
Cervical Cancer Screening Program. 
 
Inclusion Criteria: 
• 
Women 
• 
Identifying as Hispanic ethnicity 
• 
Age 40-64 if no previous mammogram in last two years 
 
**If uninsured or limited health insurance coverage, TN Breast and Cervical Cancer Screening 
Program will pay for mammogram 
- 
Annual household income of less than $41,150 for a family of 2 persons 
- 
Reside in Tennessee 
 
Exclusion Critiera: 
• 
Personal history of breast cancer 
• 
Current breast symptoms (palpable mass) 

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Recruitment:  
We aim to recruit 100 women total.  All participants will be informed that well woman screening is 
free under the TN Breast and Cervical Cancer Screening Program.  Participants will be offered $40 gift 
cards for compensation for participation. Two recruitment methods will be used.:  
 
1. The research team will identify and recruit women meeting inclusion criteria from the MWCHC 
electronic medical record.  Eligible participants identified from the MWCHC will be contacted 
via telephone.  [See recruitment material]. 
2. The research team will identify and recruit women from the local Hispanic community through 
churches, community organizations, and community events.   We will also use radio 
announcements and Facebook for recruitment [See recruitment material]. 
At the time of recruitment, women will be assisted in scheduling an appointment at MWCHC for well 
woman screening during a “Hispanic Clinic Day”. 
 
Hispanic Clinic Days:  
Women will be scheduled during one of five dedicated “Hispanic Clinic Days”.  Each clinic day will host 
up to 20 women, to a target 100 participants.  Each day there will be a morning session for 10 women 
and an afternoon session for 10 women.  The bilingual research assistant and bilingual PN will be 
present during the Hispanic Clinic Days.  At the start of each session, consent will be obtained from all 
potential participants, followed by baseline assessments, randomization and clinical care.  Gift cards 
will be distributed at time of written consent.  
 
 
 

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Consent: 
Written informed consent will be obtained for all participants by the research assistant in person at 
MWCHC [see attached consent].    
 
Baseline Assessment: 
Immediately following consent, all participants will complete a baseline assessment (English or 
Spanish according to participant preference) to collect demographic information, trust in healthcare 
system assessment, and health literacy assessment [see baseline survey].   This assessment will be 
collected by paper and pencil with the help of the research assistant. 
 
Randomization: 
Women will be randomized to the control arm, the intervention arm 1 (individual education), or the 
intervention arm 2 (group education) immediately following consent.  Randomization will be 
performed using the random number generator software available in the R statistical package (www.r-
project.org). 
 
Control Arm: 
Immediately following consent and completion of the baseline assessment, women in the control arm 
will receive standard of care well woman screening.  The control arm will receive screening results per 
MWCHC protocol. 
 
Intervention Arm 1: 
Immediately following consent and completion of the baseline assessment, women in the intervention 
arm 1 will participate in a 20-30 minute educational session [see educational slides] alone with the 
PN.  Well woman screening will follow the educational session.  The PN will be available to assist with 
questions and language interpretation as necessary. After standard delivery of screening results, the 
PN will contact these participants to answer any questions about their screening results and to assist 
with scheduling any additional tests necessary. 
 
Intervention Arm 2: 
Immediately following consent and completion of the baseline assessment, women in the intervention 
arm will participate in a 20-30  minute group educational session [see educational slides] from the 
PN.  Well woman screening will follow the educational session.  The PN will be available to assist with 
questions and language interpretation as necessary. After standard delivery of screening results, the 
PN will contact these participants to answer any questions about their screening results and to assist 
with scheduling any additional tests necessary. 
 
Post Assessment 2-5 Days After Delivery of Results: 
All participants will be contacted via telephone by the bilingual research assistant 2 -5 days after 
results are distributed by standard method for post assessment.   This will be conducted in English or 
Spanish according to participant preference.  This post assessment will repeat the measures of trust.   
It will also assess measures of satisfaction with care, satisfaction with communication, relationship 
with the promotora and intent to follow-up [see attached post assessment].  After the post 

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assessment, the existing Vanderbilt Ingram Cancer Center (VICC) Breast and Cervical Cancer pamphlet 
[see attached VICC Breast and Cervical Cancer pamphlet]. 
 
Delayed Chart Review: 
The bilingual research assistant will perform delayed chart review 2-4 weeks following delivery of 
results to assess whether patients needing follow-up diagnostic studies returned.  Delayed chart 
review may also occur in 2-3 years to assess adherence to continued screening. 
 
Data Collection: 
Baseline assessment data will be collected by paper and pencil (in Spanish or English language per 
patient request) immediately following consent at MWCHC.  The bilingual research assistant will be 
available to assist as necessary.  Post assessment data will be collected electronically in REDCap by 
bilingual research assistant via telephone.   Return for Follow-Up data will be accessed via patient 
medical record.  Data will be stored in a REDCap. 
 
Item Development: 
Baseline Assessment:  The baseline assessment will collect demographic information.  Additionally, 
the baseline assessment will assess trust in the healthcare system using the Healthcare System 
Distrust Scale4 and health literacy using the Self-Reported Health Literacy Scale5. 
 
Post Assessment:  Measures of healthcare system distrust will be repeated in the post assessment.  The 
post assessment will include multiple items to assess satisfaction with care using the Patient 
Satisfaction with Cancer Scale6, satisfaction with communication adapted from the Interpersonal 
Processes of Care Survey7, and satisfaction with the promotora8.  The post assessment will also assess 
intent to follow up. 
 
Statistical Considerations: 
Descriptive statistics will be used to analyze the demographic characteristics of participants.  
Comparison of knowledge in baseline and post assessments will be assessed with χ2, Student t tests 
and Fischer exact tests as necessary.   Open-ended responses will be analyzed qualitatively.  Post 
assessment comparison between “intervention” and “control” groups will be assessed with χ2, Student 
t tests and Fischer exact tests as necessary.  Open-ended responses will be analyzed qualitatively. 
 
Sample Size: 
For this pilot study, the proposed sample size of 50 patients/group provides at least 80% power to 
detect a 29% improvement of the success rate, i.e. 40% vs 69%, with 2 sided Type 1 error = 5%.  This 
calculation was based on the Chi squared test with the normal approximation correction for 
continuity. 
 
Anticipated Outcomes: 
Primary Outcome: 
Assess relationship between trust in healthcare system and engagement in screening mammography 
program in local Hispanic women. 

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Secondary Outcome: 
Assessment of PN impact on Hispanic women’s measures of satisfaction with communication when 
compared to those receiving standard of care treatment in the screening mammography setting. 
 
Timeline: 
Month 
 
1-2 
Identify and Educate Promotora Navigator, Identify and Educate Research Assistant 
3-6 
Recruitment  
Host Hispanic Clinic Days 
Collect Data 
7-8 
Delayed chart review for Return for Necessary Follow-Up 
Data analysis 
24-36 
Delayed chart review for follow-up screening 
References: 
1. 
Peek ME and Han JH.  Disparities in Screening Mammography.  Journal of General Internal Medicine.  2004;19:184-194. 
2. 
Escriba-Aguir VE, Rodriguez-Gomez M, and Ruiz-Perez I.  Effectiveness of patient-targeted interventions to promote cancer screening among 
ethnic minorities: A systematic review.  Cancer Epidemiology.  2016;44:22-39. 
3. 
Coronado GD, Beresford SA, McLerran D, et al.  Multilevel Intervention Raises Latina Participation in Mammography Screening:  Findings from 
Fortaleza Latina.  Cancer Epidemio Biomarker Prev.  2016;25(4):584-592. 
4. 
Shea JA, Micco E, Dean LT, et al.  Development of a Revised HealthCare System Distrust Scale.  J Gen Int Med.  2008;23(6):727-32. 
5. 
Sarkar U, Schillinger D, Lopex A.  Validation of Self-Reported Health Literacy Questions Among Diverse English and Spanish-Speaking 
Populations.  J Gen Intern Med.  2010;26(3): 265-71. 
6. 
Pascal JP, Fiscella K, Freund KM, et al.  Structural and Reliability Analysis of a Patient Satisfaction with Cancer-Related Care Measure.  Cancer 
2011;117:854-61. 
7. 
Stewart AL, Napoles-Springer AM, Gregorich SE, et al.  Interpersonal Processes of Care Survey: Patient-Reported Measures for Diverse Groups.  
Health Serv Res.  2007;42(3):1235-1256. 
8. 
Pascal JP, Fiscella FK, Winters PC et al.  Psychometric development and reliability analysis of a patient satisfaction with interpersonal 
relationship with navigator measure: a multi‐site patient navigation research program study.  Psycho-Oncology.  2011;21:986-992.