- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07549139
Overcoming Racial Disparities in Screening Mammography
August 9, 2026 updated by: Washington University School of Medicine
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
Study Type
Interventional
Enrollment (Estimated)
176
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Foluso Ademuyiwa, MD, MPH, MSCI
- Phone Number: 314-362-5654
- Email: bisiademuyiwa@wustl.edu
Study Locations
-
-
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
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Sub-Investigator:
- Debbie Bennett, MD
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Sub-Investigator:
- Ashley Housten, OTD, OTR, MSCI, MPA
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Sub-Investigator:
- Ying Liu, MD, PhD
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Sub-Investigator:
- Shaili Tapiavala, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
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.
|
Patient will receive an appointment reminder in the mail 7-10 days prior to the appointment.
The telephone counseling will include an appointment reminder within 7 days of their appointment and identify and troubleshoot barriers to patient's mammography completion.
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
Time Frame: 6 months after randomization
|
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
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Foluso Ademuyiwa, MD, MPH, MSCI, Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 31, 2026
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
April 30, 2028
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)
August 12, 2026
Last Update Submitted That Met QC Criteria
August 9, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.