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Developing and Evaluating Culturally Relevant Interventions to Improve Breast Cancer Screening

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CARE

CARE + COACH

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring mammography, cancer screening

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Center for Indigenous HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CARE - Intervention arm for mammography education

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

Arm Description

CARE is a culturally tailored mammography education module.

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.

Outcomes

Primary Outcome Measures

Mammography uptake

Mammography uptake within 2 months of referral

Secondary Outcome Measures

Full Information

NCT ID

NCT05665660

First Posted

December 19, 2022

Last Updated

July 3, 2023

Sponsor

Johns Hopkins Bloomberg School of Public Health

1. Study Identification

Unique Protocol Identification Number

NCT05665660

Brief Title

Developing and Evaluating Culturally Relevant Interventions to Improve Breast Cancer Screening

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 6, 2023 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins Bloomberg School of Public Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

mammography, cancer screening

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CARE - Intervention arm for mammography education

Arm Type

Experimental

Arm Description

CARE is a culturally tailored mammography education module.

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

CARE

Intervention Description

CARE is a culturally tailored mammography education module.

Intervention Type

Behavioral

Intervention Name(s)

CARE + COACH

Intervention Description

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

Primary Outcome Measure Information:

Title

Mammography uptake

Description

Mammography uptake within 2 months of referral

Time Frame

2 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Women

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Allison Barlow, PhD

Phone

410-614-2072

abarlow@jhu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Joel Begay, MPH

Phone

720-512-9941

jbegay2@jhu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allison Barlow, PhD

Organizational Affiliation

Johns Hopkins Bloomberg School of Public Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Indigenous Health

City

Whiteriver

State/Province

Arizona

ZIP/Postal Code

85941

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francene Larzelere

Phone

928-594-6156

12. IPD Sharing Statement

Learn more about this trial

Developing and Evaluating Culturally Relevant Interventions to Improve Breast Cancer Screening

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