Overcoming Racial Disparities in Screening Mammography

A Personalized Approach to Promote Health Equity by Overcoming Racial Disparities in Screening Mammography

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Cancer of the Breast
• Intervention / Treatment: Other: Automated phone call; Other: Appointment mail reminder; Other: Telephone counseling; Other: Digital navigation video

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Foluso Ademuyiwa, MD, MPH, MSCI; Phone Number: 314-362-5654; Email: bisiademuyiwa@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
      • Contact: Foluso Ademuyiwa, MD, MPH, MSCI; Phone Number: 314-362-5654; Email: bisiademuyiwa@wustl.edu
      • Principal Investigator: Foluso Ademuyiwa, MD, MPH, MSCI
      • Sub-Investigator: Debbie Bennett, MD
      • Sub-Investigator: Ashley Housten, OTD, OTR, MSCI, MPA
      • Sub-Investigator: Ying Liu, MD, PhD
      • Sub-Investigator: Shaili Tapiavala, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Usual Care; 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; Patient will receive an automated reminder phone call for their appointment 1-3 days prior to the appointment.
Experimental: Arm 2: Culturally Tailored Patient Centric Program Methods; 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 reminder; Patient will receive an appointment reminder in the mail 7-10 days prior to the appointment.; Other: Telephone counseling; The telephone counseling will include an appointment reminder within 7 days of their appointment and identify and troubleshoot barriers to patient's mammography completion.; Other: Digital navigation video; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Novartis; National Comprehensive Cancer Network
• Investigators: Principal Investigator: Foluso Ademuyiwa, MD, MPH, MSCI, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Mammography; Disparities; Black women; Breast cancer screening; No-show rates
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 202604048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No