NCT04996316

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
• Phase: —
• Study type: Observational
• Enrollment: 1,141 (estimated)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: Female
• Age: 40 Years – 74 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Electronic Health Record Review	Health record reviewed
OTHER	Interview	Participate in interview
OTHER	Media Intervention	Use MammoScreen
OTHER	Survey Administration	Complete survey
OTHER	Training and Education	Undergo training

Timeline

• Start date: 2022-09-07
• Primary completion: 2025-04-30
• Completion: 2026-08-31
• First posted: 2021-08-09
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States