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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Breast Carcinoma
• Intervention / Treatment: Other: Interview; Other: Survey Administration; Other: Electronic Health Record Review; Other: Training and Education; Other: Media Intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 1141

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women between the ages of 40 and 74

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Interview; Participate in interview; Other: Survey Administration; Complete survey; Other: Electronic Health Record Review; Health record reviewed; Other: Training and Education; Undergo training
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.	Other: Interview; Participate in interview; Other: Electronic Health Record Review; Health record reviewed; Other: Media Intervention; Use MammoScreen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 5 years
Number of women with above-average risk for breast cancer identified by MammoScreen integrated with the electronic health record		Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of mammography screening referral		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.	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.	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.	Up to 5 years
Number of above average risk MammoScreen users who completed a genetic counseling visit		Up to 5 years
Number of above average risk MammoScreen users who had a genetic test done		Up to 5 years

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University; Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Karen Eden, Ph.D., Department of Medical Informatics and Clinical Epidemiology, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Actual): April 30, 2025
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Socioeconomic Factors; Population Characteristics; Interviews as Topic; Educational Status
• Other Study ID Numbers: STUDY00022698 (Other Identifier: OHSU Knight Cancer Institute); NCI-2021-06583 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01HS027796 (U.S. AHRQ Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No