NCT04996316

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,141

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Sep 2022Aug 2026

First Submitted

Initial submission to the registry

August 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 7, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2.6 years

First QC Date

August 2, 2021

Last Update Submit

February 10, 2026

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Rates of mammography screening referral

    Up to 5 years

  • Screening completed

    Up to 5 years

  • Mammography results

    Up to 5 years

  • Number of above average risk MammoScreen users who received a genetic counseling referral

    Up to 5 years

  • Number of above average risk MammoScreen users who completed a genetic counseling visit

    Up to 5 years

  • +1 more secondary outcomes

Study Arms (2)

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: Electronic Health Record ReviewOther: InterviewOther: Survey AdministrationOther: 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.

Other: Electronic Health Record ReviewOther: InterviewOther: Media Intervention

Interventions

Survey AdministrationOTHER

Complete survey

Clinical staff (interview, training, survey)
Training and EducationOTHER

Undergo training

Clinical staff (interview, training, survey)
Electronic Health Record ReviewOTHER

Health record reviewed

Clinical staff (interview, training, survey)Patients (interview, MammoScreen)
InterviewOTHER

Participate in interview

Clinical staff (interview, training, survey)Patients (interview, MammoScreen)
Media InterventionOTHER

Use MammoScreen

Patients (interview, MammoScreen)

Eligibility Criteria

Age40 Years - 74 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women between the ages of 40 and 74

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Interviews as TopicEducational Status

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Karen Eden, Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 2, 2021

First Posted

August 9, 2021

Study Start

September 7, 2022

Primary Completion

April 30, 2025

Study Completion (Estimated)

August 31, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

US(1)