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Developing and Evaluating Culturally Relevant Interventions to Improve Breast Cancer Screening

NCT ID: NCT05665660

Last Updated: 2025-12-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2025-10-20

Brief Summary

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The goal of this study is to evaluate the relative benefits of an intervention to promote breast cancer screening among women in the White Mountain Apache (WMA) community. Women will be randomized to receive CARE, a culturally tailored mammography education module, or CARE+COACH, which is the CARE education module plus access to an Apache paraprofessional women's health coach (i.e., patient navigator). The CARE intervention was developed through a community-based participatory research process. The primary outcome is mammography uptake within 2 months of a referral.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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mammography cancer screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Women randomized to receive CARE who have not received a mammography at 3 months will be offered CARE+COACH to facilitate completion of their screening and contacted at 4 months.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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CARE - Intervention arm for mammography education

CARE is a culturally tailored mammography education module.

Group Type EXPERIMENTAL

CARE

Intervention Type BEHAVIORAL

CARE is a culturally tailored mammography education module.

CARE + COACH - Intervention arm for mammography education + a patient navigator

CARE + COACH is the CARE education module in addition to a COACH, which is access to an Apache paraprofessional women's health coach. The Coach functions like a patient navigator.

Group Type EXPERIMENTAL

CARE + COACH

Intervention Type BEHAVIORAL

CARE + COACH is a culturally tailored mammography education module + access to an Apache paraprofessional women's health coach who functions as a patient navigator

Interventions

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CARE

CARE is a culturally tailored mammography education module.

Intervention Type BEHAVIORAL

CARE + COACH

CARE + COACH is a culturally tailored mammography education module + access to an Apache paraprofessional women's health coach who functions as a patient navigator

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Referral for screening mammography from a Whiteriver Indian Health Service provider
* Self-identify as American Indian or Alaska Native (AIAN)
* Female
* Live on within 60 miles of the Fort Apache Indian Reservation

Exclusion Criteria

* Women who have received a mammogram within the prior 12 months
* Women with a personal history of breast cancer
* Unable to participate in full intervention or evaluation due to an anticipated event (e.g., planned move)
* Unwilling to be randomized
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Native American Research Center for Health

OTHER

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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Allison Barlow, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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Center for Indigenous Health

Whiteriver, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00022667

Identifier Type: -

Identifier Source: org_study_id