Community-led Navigation to Address Disparities in Mammography Among Native American Women

NCT06957535 | Recruiting

• 1 other identifier: IRB00031873
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the effectiveness of an intervention to promote breast cancer screening mammography among women in one community on the Navajo Nation. The intervention is Tablet-based Education to improve the Acceptance of Mammography (TEAM). TEAM encompasses culturally-tailored mammography education modules that were developed using a community-based participatory research process. Women will be randomized to receive TEAM or TEAM + Navigation. Navigation involves monthly 1:1 support from a Diné peer-navigator.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants with mammography

  Mammography uptake within 3 months of referral

  3 months post baseline

Study Arms (2)

TEAM

ACTIVE COMPARATOR

TEAM (Tablet-based Education to improve the Acceptance of Mammography)

Behavioral: TEAM

TEAM + Navigation

EXPERIMENTAL

TEAM (Tablet-based Education to improve the Acceptance of Mammography) and Navigation (provision of 1:1 support from a Diné peer-navigator)

Behavioral: Navigation; Behavioral: TEAM

Interventions

Navigation BEHAVIORAL

Navigation is provision of 1:1 support from a Diné peer-navigator

TEAM + Navigation

TEAM BEHAVIORAL

TEAM encompasses culturally tailored mammography education modules

TEAM; TEAM + Navigation

Eligibility Criteria

• Age: 40 Years - 74 Years
• Gender Eligibility Details: Self-identify as female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identify as American Indian or Alaska Native (AIAN)
• Identify as Female
• Are 40-74 years of age
• Are a registered patient at Chinle Comprehensive HealthCare Facility (CCHFC)
• Live within 80 miles of CCHFC
• Have not received a mammogram within the prior 12 months
• Do not have a personal history of breast cancer
• Are not planning to move in the next 6 months
• Willing to be randomized

You may not qualify if:

• Do not self-identify as American Indian or Alaska Native (AIAN)
• Do not identify as Female
• Are not 40-74 years of age
• Are not a registered patient at CCHCF
• Do not live within 80 miles of CCHCF
• Have received a mammogram within the prior 12 months
• Have a personal history of breast cancer
• Are planning to move in the next 6 months
• Unwilling to be randomized

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Genentech Foundation: collaborator

Study Sites (1)

Navajo Nation Center for Indigenous Health

Chinle, Arizona, 86503, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Katie Nelson, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Nelson, PhD

CONTACT

410-955-6931; knelso46@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)