Developing and Evaluating Culturally Relevant Interventions to Improve Breast Cancer Screening

NCT05665660 | Completed

• 1 other identifier: IRB00022667
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

mammography; cancer screening

Outcome Measures

Primary Outcomes (1)

• Mammography uptake

  Mammography uptake within 2 months of referral

  2 months

Study Arms (2)

CARE - Intervention arm for mammography education

EXPERIMENTAL

CARE is a culturally tailored mammography education module.

Behavioral: CARE

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

EXPERIMENTAL

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

Interventions

CARE BEHAVIORAL

CARE is a culturally tailored mammography education module.

CARE - Intervention arm for mammography education

CARE + COACH 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

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

Eligibility Criteria

• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Native American Research Center for Health: collaborator
• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Center for Indigenous Health

Whiteriver, Arizona, 85941, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Allison Barlow, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 27, 2022
• Study Start: June 6, 2023
• Primary Completion: September 26, 2025
• Study Completion: October 20, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)