Breast CarcinomaNCT04996316
MammoScreen Breast Cancer Risk Assessment and Decision Aid for Breast Cancer Screening and Referrals
An observational study of Breast Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This study collects information to implement MammoScreen for Breast Cancer Screening and Referrals. MammoScreen is a risk assessment questionnaire that identifies individuals at average and increased risk for breast cancer and guides their screening decisions. Read more about this study
- Who is it for?
- Ages 40 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Electronic Health Record Review, Interview and Media Intervention
- How many people
- 1,141 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2022to 31 Aug 2026
- Phase
- Observational
- 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 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women between the ages of 40 and 74
Who may be able to join
- Women between the ages of 40 and 74
- Enrolled in MyChart
- Able to read English
Who cannot join
- Personal history of breast or ovarian cancer
- Currently Pregnant
- Currently in Hospice
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
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Implementing USPSTF Recommendations for Breast Cancer Screening and Prevention by Integrating Clinical Decision Support Tools With the Electronic Health Record
This study collects information to implement MammoScreen for Breast Cancer Screening and Referrals. MammoScreen is a risk assessment questionnaire that identifies individuals at average and increased risk for breast cancer and guides their screening decisions.
Read the detailed description
PRIMARY OBJECTIVES:
- Uptake of MammoScreen (the proportion of women who enroll and use MammoScreen, also referred to as Reach.
II. Identification of women with above-average risk for breast cancer by MammoScreen integrated with the electronic health record (EHR).
SECONDARY OUTCOMES:
- Rates of mammography screening referral. II. Screening completed and mammography results stratified by risk category. III. Among those who meet criteria, genetic counseling referral, visit completed and genetic test done.
OUTLINE:
CLINICAL STAFF: During development some clinical team members will participate in usability testing (up to 30 minutes) of the electronic health record interface with MammoScreen. Some participants will undergo training sessions of about 20 minutes, then participate in interviews lasting up to 30 minutes at baseline prior to MammoScreen launch. Clinical staff also participate in interviews up to 30 minutes after MammoScreen launch during years 2-4. Participants complete surveys during the maintenance phase about six months after the last reminders are sent.
PATIENTS: Patients (enrolled from OHSU IMC) participate in interviews lasting up to 1 hour. Patients medical records are reviewed. Patients will be invited via MyChart to use the MammoScreen. Reminders will be sent via MyChart to non-respondents at 2 and 4 weeks. Patients will use MammoScreen one time right after enrollment. Some patients may also participate in interviews up to 1 hour each during years 3-5.
- Conditions
- Breast Carcinoma
- Being tested
- Electronic Health Record Review, Interview, Media Intervention, Survey Administration, Training and Education
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Health record reviewed
InterviewOther
Participate in interview
Media InterventionOther
Use MammoScreen
Survey AdministrationOther
Complete survey
Training and EducationOther
Undergo training
| Study group | Role | What they receive |
|---|---|---|
| Clinical staff (interview, training, survey) | Before implementation, some participants will complete usability testing of the interface in the electronic health record and MammoScreen. Participants undergo training sessions over 20 minutes and participate in interviews over 30 minutes at baseline, prior to MammoScreen launch. Clinical staff also participate in interviews over 30 minutes after MammoScreen launch during years 2-4. Participants complete surveys during the maintenance phase, about six months after the last reminders are sent. Receives: Other: Electronic Health Record Review; Other: Interview; Other: Survey Administration; Other: Training and Education | |
| Patients (interview, MammoScreen) | Patients participate in interviews up to 1 hour. Patients medical records are reviewed. Patients use the MammoScreen at enrollment. Some Patients will also participate in interviews up to 1 hour, each during years 3-5. Receives: Other: Electronic Health Record Review; Other: Interview; Other: Media Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of MammoScreen
Defined as the proportion of women who enroll and use MammoScreen. Proportions of invitations for newly eligible women and uptake of MammoScreen during the maintenance period, overall and by clinical team, will be characterized along with 95% exact confidence intervals.
Measured: Up to 5 years
Number of women with above-average risk for breast cancer identified by MammoScreen integrated with the electronic health record
Measured: Up to 5 years
Secondary outcomes (6)
Rates of mammography screening referral
Measured: Up to 5 years
Screening completed
The proportions of patients who open, and complete MammoScreen and 95% confidence intervals will be calculated. Demographic and clinical characteristics of patients who complete MammoScreen versus those who do not will be compared using a two-sample t-test or chi-square test as appropriate. Variation in completing MammoScreen by patient (e.g., age) and provider characteristics (e.g., panel size) will be explored.
Measured: Up to 5 years
Mammography results
Will be stratified by risk category. Will be analyzed similarly using proportions and 95% confidence intervals, and a regression model if allowed by data.
Measured: Up to 5 years
Number of above average risk MammoScreen users who received a genetic counseling referral
Will be analyzed similarly using proportions and 95% confidence intervals, and a regression model if allowed by data.
Measured: Up to 5 years
Number of above average risk MammoScreen users who completed a genetic counseling visit
Measured: Up to 5 years
Number of above average risk MammoScreen users who had a genetic test done
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start7 Sep 2022
- Primary completion30 Apr 2025
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Oregon Health and Science University
- Responsible party
- Principal investigator, Karen Eden, Ph.D., OHSU Knight Cancer Institute
- Investigators
- Karen Eden, Ph.D., Principal investigator, Department of Medical Informatics and Clinical Epidemiology, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996316
- Sponsor's protocol ID
- STUDY00022698
- Other IDs
- NCI-2021-06583, STUDY00022698, R01HS027796
- Status last verified
- Feb 2026
- First submitted
- 2 Aug 2021
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing USPSTF Recommendations for Breast Cancer Screening and Prevention by Integrating Clinical Decision Support Tools With the Electronic Health Record
- ClinicalTrials.gov ID
- NCT04996316
- Acronym / sponsor ID
- STUDY00022698
- Conditions
- Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,141 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Oregon Health and Science University
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 9 Aug 2021 (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.
This study collects information to implement MammoScreen for Breast Cancer Screening and Referrals. MammoScreen is a risk assessment questionnaire that identifies individuals at average and increased risk for breast cancer and guides their screening decisions.
Detailed description
PRIMARY OBJECTIVES:
- Uptake of MammoScreen (the proportion of women who enroll and use MammoScreen, also referred to as Reach.
II. Identification of women with above-average risk for breast cancer by MammoScreen integrated with the electronic health record (EHR).
SECONDARY OUTCOMES:
- Rates of mammography screening referral. II. Screening completed and mammography results stratified by risk category. III. Among those who meet criteria, genetic counseling referral, visit completed and genetic test done.
OUTLINE:
CLINICAL STAFF: During development some clinical team members will participate in usability testing (up to 30 minutes) of the electronic health record interface with MammoScreen. Some participants will undergo training sessions of about 20 minutes, then participate in interviews lasting up to 30 minutes at baseline prior to MammoScreen launch. Clinical staff also participate in interviews up to 30 minutes after MammoScreen launch during years 2-4. Participants complete surveys during the maintenance phase about six months after the last reminders are sent.
PATIENTS: Patients (enrolled from OHSU IMC) participate in interviews lasting up to 1 hour. Patients medical records are reviewed. Patients will be invited via MyChart to use the MammoScreen. Reminders will be sent via MyChart to non-respondents at 2 and 4 weeks. Patients will use MammoScreen one time right after enrollment. Some patients may also participate in interviews up to 1 hour each during years 3-5.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical staff (interview, training, survey) | – | Other: Electronic Health Record Review, Other: Interview, Other: Survey Administration, Other: Training and EducationBefore implementation, some participants will complete usability testing of the interface in the electronic health record and MammoScreen. Participants undergo training sessions over 20 minutes and participate in interviews over 30 minutes at baseline, prior to MammoScreen launch. Clinical staff also participate in interviews over 30 minutes after MammoScreen launch during years 2-4. Participants complete surveys during the maintenance phase, about six months after the last reminders are sent. |
| Patients (interview, MammoScreen) | – | Other: Electronic Health Record Review, Other: Interview, Other: Media InterventionPatients participate in interviews up to 1 hour. Patients medical records are reviewed. Patients use the MammoScreen at enrollment. Some Patients will also participate in interviews up to 1 hour, each during years 3-5. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women between the ages of 40 and 74
Key inclusion criteria (3 listed)
- Women between the ages of 40 and 74
- Enrolled in MyChart
- Able to read English
Key exclusion criteria (3 listed)
- Personal history of breast or ovarian cancer
- Currently Pregnant
- Currently in Hospice
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 |
|---|---|---|
| Electronic Health Record ReviewHealth record reviewed | Other | Clinical staff (interview, training, survey), Patients (interview, MammoScreen) |
| InterviewParticipate in interview | Other | Clinical staff (interview, training, survey), Patients (interview, MammoScreen) |
| Media InterventionUse MammoScreen | Other | Patients (interview, MammoScreen) |
| Survey AdministrationComplete survey | Other | Clinical staff (interview, training, survey) |
| Training and EducationUndergo training | Other | Clinical staff (interview, training, survey) |
Primary outcome
Uptake of MammoScreen
Time frame: Up to 5 years
Defined as the proportion of women who enroll and use MammoScreen. Proportions of invitations for newly eligible women and uptake of MammoScreen during the maintenance period, overall and by clinical team, will be characterized along with 95% exact confidence intervals.
Number of women with above-average risk for breast cancer identified by MammoScreen integrated with the electronic health record
Time frame: Up to 5 years
6 secondary outcomes
Rates of mammography screening referral
Time frame: Up to 5 years
Screening completed
Time frame: Up to 5 years
Mammography results
Time frame: Up to 5 years
Number of above average risk MammoScreen users who received a genetic counseling referral
Time frame: Up to 5 years
Number of above average risk MammoScreen users who completed a genetic counseling visit
Time frame: Up to 5 years
Number of above average risk MammoScreen users who had a genetic test done
Time frame: Up to 5 years
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 13 Feb 2026.
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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.
Karen Eden, Ph.D. principal investigator
Department of Medical Informatics and Clinical Epidemiology, OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by OHSU Knight Cancer Institute 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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 13 Feb 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of MammoScreen (time frame: Up to 5 years). The study lists 2 primary outcomes in all. 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 13 Feb 2026.