Promotora Navigator - Culturally Appropriate Patient Navigator

• ClinicalTrials.gov Identifier: NCT03557801
• Recruitment Status: Completed
• First Posted: June 15, 2018
• Results First Posted: July 31, 2019
• Last Update Posted: August 14, 2019
• Sponsor: Vanderbilt University Medical Center
• Information provided by (Responsible Party): Lucy Spalluto, Vanderbilt University Medical Center

Study Description

Brief Summary:

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 addressed. In the 40-65 year old age range, there is significant disparity in screening mammography utilization in Hispanic women compared to their white counterparts.

Culturally adapted patient-targeted healthcare interventions can help reduce ethnic inequalities in access to cancer screening programs. Promotoras, culturally appropriate patient navigators for the Hispanic community, have been shown to increase screening mammography rates in the Hispanic/Latino population.

However, there is little research exploring the interaction between these lay community health workers and community members. This proposal aims to assess this interaction by measuring the impact of a Promotora working with community members in either a group setting or individual setting. Understanding this interaction can lead to more effectively designed future community interventions. Primary outcomes in this study will include women's reported measures of interpersonal processes of care (communication and interpersonal style) during screening mammography care, trust in the healthcare system, and satisfaction with cancer screening care when compared to those receiving standard of care.

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Screening Mammography; Community Health Worker	Behavioral: Mammography with Community Health Worker (individual); Behavioral: Mammography with Community Health Worker (group); Other: Standard of Care Mammography	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Assessing the Impact of a Community Health Worker on Hispanic Women's Reported Measures of Processes of Care in the Screening Mammography Setting
• Actual Study Start Date: June 7, 2018
• Actual Primary Completion Date: October 15, 2018
• Actual Study Completion Date: October 15, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Standard of Care Mammography; 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 standard of care protocol.	Other: Standard of Care Mammography; 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 standard protocol.
Experimental: Mammography with Community Health Worker (individual); Immediately following consent and completion of the baseline assessment, women in the intervention arm 1 will participate in a 20-30 minute educational session alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.	Behavioral: Mammography with Community Health Worker (individual); Immediately following consent and completion of the baseline assessment, alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
Experimental: Mammography with Community Health Worker (group); Immediately following consent and completion of the baseline assessment, women in the intervention arm will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.	Behavioral: Mammography with Community Health Worker (group); Immediately following consent and completion of the baseline assessment, women in the intervention arm will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.

Outcome Measures

Primary Outcome Measures :

1. Patient Reported Measures From Interpersonal Processes of Care Survey [ Time Frame: Approximately 2 weeks after consent/screening mammogram. ]
   Selected scales (communication and interpersonal style) of the Interpersonal Processes of Care Survey will be the primary outcome. A total of 18 (corrected from orginal submission) questions will be administered. The questions are scored on a scale from 1-5 with higher scores indicating higher frequencies of the construct. The compiled scores will range from 5-90. Scales with negative associations (discrimination, hurried communication) will be reversed. Thus, higher scores for all items will indicate a more positive experience.

Secondary Outcome Measures :

1. Patient Reported Measures From the Distrust in the Healthcare System Scale. Reported at Baseline and Post Intervention. Also Reported as the Change Between Baseline and Intervention. [ Time Frame: Baseline, approximately 2 weeks after consent/screening mammogram. ]
   Distrust will be measured with the Revised Healthcare System Distrust Scale. This 9 question scale is divided into two subscales: competence and values. The questions are scored on a scale from 1-5. The total score will range 5-45, with higher scores indicating higher levels of trust. Baseline distrust measured at time of initial consent/screening. Post-intervention distrust measured at time of post-survey which took place approximately 2 weeks after screening (varied as to when patient could be reached for survey). Difference in distrust is subtracts the baseline score from the post score.
2. Patient Reported Measures From the Satisfaction With Cancer Related Care Scale. [ Time Frame: Approximately 2 weeks after consent/screening mammogram. ]
   Satisfaction with care will be measured with the Patient Satisfaction with Cancer-Related Care (PSCC) Measure. This is an 18 question measure. The questions are scored on a scale from 1-5. The total score will range 5-90, higher scores indicate higher satisfaction with care.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 64 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Women
• Identifying as Hispanic ethnicity
• Age 40-64
• Tennessee resident

Exclusion Criteria:

• Personal history of breast cancer
• Current breast symptoms (palpable mass)

Contacts and Locations

Locations

United States, Tennessee

Matthew Walker Comprehensive Health Center

Nashville, Tennessee, United States, 37208

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

• Principal Investigator: Lucy Spalluto, MD; Vanderbilt University Medical Center

  Study Documents (Full-Text)

Documents provided by Lucy Spalluto, Vanderbilt University Medical Center:

Study Protocol and Statistical Analysis Plan  [PDF] June 6, 2018

More Information

• Responsible Party: Lucy Spalluto, Assistant Professor, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03557801
• Other Study ID Numbers: 180276
• First Posted: June 15, 2018
• Results First Posted: July 31, 2019
• Last Update Posted: August 14, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No