Developing and Evaluating Culturally Relevant Interventio... | NCT05665660

Studies
Developing and Evaluating Culturally Relevant Interventions to Improve Breast Cancer Screening

NCT05665660

Sponsor

Johns Hopkins Bloomberg School of Public Health

Status

Completed

Last Update Posted

Dec 24, 2025Actual

Enrollment

323Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

CARE
CARE + COACH

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2023Actual

Primary Completion Date

Sep 26, 2025Actual

Completion Date

Oct 20, 2025Actual

First Submitted Date

Dec 19, 2022

First Submission Date that Met QC Criteria

Dec 19, 2022

First Posted Date

Dec 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2025

Last Update Posted Date

Dec 24, 2025Actual

Name	Class
Native American Research Center for Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

323Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CARE	Behavioral	CARE is a culturally tailored mammography education module.	CARE - Intervention arm for mammography education

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allison Barlow, PhD	Johns Hopkins Bloomberg School of Public Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Indigenous Health		Whiteriver	Arizona	85941	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided