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

NCT ID: NCT06957535

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-02

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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TEAM

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

Group Type ACTIVE_COMPARATOR

TEAM

Intervention Type BEHAVIORAL

TEAM encompasses culturally tailored mammography education modules

TEAM + Navigation

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

Group Type EXPERIMENTAL

Navigation

Intervention Type BEHAVIORAL

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

TEAM

Intervention Type BEHAVIORAL

TEAM encompasses culturally tailored mammography education modules

Interventions

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Navigation

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

Intervention Type BEHAVIORAL

TEAM

TEAM encompasses culturally tailored mammography education modules

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Genentech Foundation

UNKNOWN

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katie Nelson, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Navajo Nation Center for Indigenous Health

Chinle, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Katie Nelson, PhD

Role: CONTACT

410-955-6931

Facility Contacts

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Kristen Mitchell, MS

Role: primary

928-674-5051

Other Identifiers

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IRB00031873

Identifier Type: -

Identifier Source: org_study_id

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