Developing and Evaluating Culturally Relevant Interventions to Improve Breast Cancer Screening

December 17, 2025 updated by: Johns Hopkins Bloomberg School of Public Health

Developing and Evaluating Scalable and Culturally Relevant Interventions to Improve Breast Cancer Screening Among White Mountain Apache Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

323

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Whiteriver, Arizona, United States, 85941
        • Center for Indigenous Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CARE - Intervention arm for mammography education
CARE is a culturally tailored mammography education module.
Behavioral: CARE
CARE is a culturally tailored mammography education module.
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mammography uptake
Time Frame: 2 months
Mammography uptake within 2 months of referral
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Native American Research Center for Health

Investigators

  • Principal Investigator: Allison Barlow, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2023

Primary Completion (Actual)

September 26, 2025

Study Completion (Actual)

October 20, 2025

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

December 19, 2022

First Posted (Actual)

December 27, 2022

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00022667

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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