Breast CancerNCT07549139
Overcoming Racial Disparities in Screening Mammography
A study testing Appointment mail reminder, Telephone counseling and Digital navigation video in people with Breast Cancer and Cancer of the Breast, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cancer of the Breast
- What is being tested?
- Appointment mail reminder, Telephone counseling and Digital navigation video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
Foluso Ademuyiwa, MD, MPH, MSCI, 314-362-5654, bisiademuyiwa@wustl.edu
Foluso Ademuyiwa, MD, MPH, MSCI
About this study
Official title: 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.
- Conditions
- Breast Cancer, Cancer of the Breast
- Being tested
- Appointment mail reminder, Telephone counseling, Digital navigation video, Automated phone call
- Keywords
- Breast cancer screening, Mammography, Black women, Disparities, No-show rates
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appointment mail reminderOther
Patient will receive an appointment reminder in the mail 7-10 days prior to the appointment.
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.
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.
Automated phone callOther
Patient will receive an automated reminder phone call for their appointment 1-3 days prior to the appointment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Appointment mail reminder; Other: Telephone counseling; Other: Digital navigation video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start31 Oct 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network, Novartis
- Responsible party
- Sponsor
- Investigators
- Foluso Ademuyiwa, MD, MPH, MSCI, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549139
- Sponsor's protocol ID
- 202604048
- Status last verified
- Aug 2026
- First submitted
- 17 Apr 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Approach to Promote Health Equity by Overcoming Racial Disparities in Screening Mammography
- ClinicalTrials.gov ID
- NCT07549139
- Acronym / sponsor ID
- 202604048
- Conditions
- Breast Cancer, Cancer of the Breast
- Keywords
- Breast cancer screening, Mammography, Black women, Disparities, No-show rates
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network, Novartis
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Usual Care | Active comparator | Other: Automated phone callPatients 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. |
| Arm 2: Culturally Tailored Patient Centric Program Methods | Experimental | Other: Appointment mail reminder, Other: Telephone counseling, Other: Digital navigation videoPatients 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Woman
- At least 40 years old
- Self-identify as Black
- English-speaking
- Scheduled for a screening mammogram within 8 weeks of study entry
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Appointment mail reminderPatient will receive an appointment reminder in the mail 7-10 days prior to the appointment. | Other | Arm 2: Culturally Tailored Patient Centric Program Methods |
| Telephone counselingThe telephone counseling will include an appointment reminder within 7 days of their appointment and identify and troubleshoot barriers to patient's mammography completion. | Other | Arm 2: Culturally Tailored Patient Centric Program Methods |
| Digital navigation videoThe 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. | Other | Arm 2: Culturally Tailored Patient Centric Program Methods |
| Automated phone callPatient will receive an automated reminder phone call for their appointment 1-3 days prior to the appointment. | Other | Arm 1: Usual Care |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Foluso Ademuyiwa, MD, MPH, MSCI principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appointment mail reminder, Telephone counseling and Digital navigation video in people with Breast Cancer and Cancer of the Breast, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Foluso Ademuyiwa, MD, MPH, MSCI (314-362-5654, bisiademuyiwa@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No-show rate (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.