NCT07549139

Brief Summary

The purpose of this study is to increase screening mammography among Black women by implementing and evaluating a culturally tailored patient-centric program designed to address barriers to screening. By performing a randomized clinical trial, this study aims to develop effective strategies to improve adherence to screening mammography and contribute to reducing health disparities in breast cancer outcomes.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
18mo left

Started May 2026

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 31, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

April 17, 2026

Last Update Submit

April 17, 2026

Conditions

Breast CancerCancer of the Breast

Keywords

Breast cancer screeningMammographyBlack womenDisparitiesNo-show rates

Outcome Measures

Primary Outcomes (1)

  • No-show rate

    Defined as the proportion of participants who do not complete (or do not reschedule) their screening mammogram appointment within 6 months of randomization.

    6 months after randomization

Study Arms (2)

Arm 1: Usual Care

ACTIVE COMPARATOR

Patients will receive the institution's usual care for screening mammogram, which consists of an automated reminder phone call from the breast health center 1-3 days prior to a scheduled appointment.

Other: Automated phone call

Arm 2: Culturally Tailored Patient Centric Program Methods

EXPERIMENTAL

Patients will receive mail reminders at 7-10 days prior to appointment, tailored telephone counseling to both serve as an appointment reminder and to identify and troubleshoot salient barriers to mammography completion, and a digital navigation video explaining the rationale for and the actual mammography procedure. All study procedures are carried out remotely with no additional research visits for participants.

Other: Appointment mail reminderOther: Telephone counselingOther: Digital navigation video

Interventions

Appointment mail reminderOTHER

Patient will receive an appointment reminder in the mail 7-10 days prior to the appointment.

Arm 2: Culturally Tailored Patient Centric Program Methods
Telephone counselingOTHER

The telephone counseling will include an appointment reminder within 7 days of their appointment and identify and troubleshoot barriers to patient's mammography completion.

Arm 2: Culturally Tailored Patient Centric Program Methods
Digital navigation videoOTHER

The digital navigation video will explain the rationale for the mammogram and the mammography procedure. Digital navigation video will be sent by SMS text message 1-3 days prior to the appointment.

Arm 2: Culturally Tailored Patient Centric Program Methods
Automated phone callOTHER

Patient will receive an automated reminder phone call for their appointment 1-3 days prior to the appointment.

Arm 1: Usual Care

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman
  • At least 40 years old
  • Self-identify as Black
  • English-speaking
  • Scheduled for a screening mammogram within 8 weeks of study entry
  • Able to understand and willing to sign an IRB approved written informed consent document.

You may not qualify if:

  • A previous history of breast cancer
  • Scheduled for a diagnostic mammogram
  • Has a documented or uncorrectable cognitive, hearing, or visual impairment.
  • Too ill to participate (diagnosed with or suffering from a condition that, in the judgment of the investigator, may limit participation in the study).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Foluso Ademuyiwa, MD, MPH, MSCI

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Foluso Ademuyiwa, MD, MPH, MSCI

CONTACT

314-362-5654bisiademuyiwa@wustl.edu

Study Design

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

Study Record Dates

First Submitted

April 17, 2026

First Posted

April 23, 2026

Study Start (Estimated)

May 31, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)