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Enrolling by invitation NCT04996316

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

Observational Breast Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electronic Health Record Review, Interview, Media Intervention, Survey Administration.
Who it may be relevant to
Registry conditions: Breast Carcinoma. Basic parameters: 40 years — 74 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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

Primary outcome measures

  • Uptake of MammoScreen [Time frame: Up to 5 years]
  • 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]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

United States · 1 center
  • OHSU Knight Cancer Institute — Portland

Identifiers

NCT: NCT04996316 · STUDY00022698 · NCI-2021-06583 · STUDY00022698 · R01HS027796

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗