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MammoScreen Breast Cancer Risk Assessment and Decision Aid for Breast Cancer Screening and Referrals

Implementing USPSTF Recommendations for Breast Cancer Screening and Prevention by Integrating Clinical Decision Support Tools With the Electronic Health Record

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04996316
Enrollment
1141
Registered
2021-08-09
Start date
2022-09-07
Completion date
2026-08-31
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma

Brief 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.

Detailed description

PRIMARY OBJECTIVES: I. 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: I. 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.

Interventions

Undergo training

OTHERSurvey Administration

Complete survey

OTHERElectronic Health Record Review

Health record reviewed

OTHERInterview

Participate in interview

OTHERMedia Intervention

Use MammoScreen

Sponsors

OHSU Knight Cancer Institute
Lead SponsorOTHER
Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Oregon Health and Science University
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 74 Years
Healthy volunteers
Yes

Inclusion criteria

* Women between the ages of 40 and 74 * Enrolled in MyChart * Able to read English

Exclusion criteria

* Personal history of breast or ovarian cancer * Currently Pregnant * Currently in Hospice

Design outcomes

Primary

MeasureTime frameDescription
Uptake of MammoScreenUp to 5 yearsDefined 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 recordUp to 5 years

Secondary

MeasureTime frameDescription
Screening completedUp to 5 yearsThe 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.
Mammography resultsUp to 5 yearsWill be stratified by risk category. Will be analyzed similarly using proportions and 95% confidence intervals, and a regression model if allowed by data.
Number of above average risk MammoScreen users who received a genetic counseling referralUp to 5 yearsWill be analyzed similarly using proportions and 95% confidence intervals, and a regression model if allowed by data.
Number of above average risk MammoScreen users who completed a genetic counseling visitUp to 5 years
Number of above average risk MammoScreen users who had a genetic test doneUp to 5 years
Rates of mammography screening referralUp to 5 years

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKaren Eden, Ph.D.

Department of Medical Informatics and Clinical Epidemiology, OHSU Knight Cancer Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026