Promotora Navigator - Culturally Appropriate Patient Navigator

NCT03557801 | Completed Results

• 1 other identifier: 180276
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Screening Mammography; Community Health Worker

Outcome Measures

Primary Outcomes (1)

• Patient Reported Measures From Interpersonal Processes of Care Survey

  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.

  Approximately 2 weeks after consent/screening mammogram.

Secondary Outcomes (2)

• 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.

  Baseline, approximately 2 weeks after consent/screening mammogram.

• Patient Reported Measures From the Satisfaction With Cancer Related Care Scale.

  Approximately 2 weeks after consent/screening mammogram.

Study Arms (3)

Standard of Care Mammography

ACTIVE COMPARATOR

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

Mammography with Community Health Worker (individual)

EXPERIMENTAL

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)

Mammography with Community Health Worker (group)

EXPERIMENTAL

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)

Interventions

Mammography with Community Health Worker (individual) BEHAVIORAL

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.

Mammography with Community Health Worker (individual)

Mammography with Community Health Worker (group) BEHAVIORAL

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.

Mammography with Community Health Worker (group)

Standard of Care Mammography OTHER

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.

Standard of Care Mammography

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Matthew Walker Comprehensive Health Center

Nashville, Tennessee, 37208, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Community Health Workers; Population Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services; Demography; Population Characteristics

Results Point of Contact

• Title: Dr. Lucy Spalluto
• Organization: Vanderbilt University Medical Center

lucy.b.spalluto@vumc.org

615 343 1187

Study Officials

• Lucy Spalluto, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 15, 2018
• Study Start: June 7, 2018
• Primary Completion: October 15, 2018
• Study Completion: October 15, 2018
• Last Updated: August 14, 2019
• Results First Posted: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)