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Enrolling by Invitation

NCT Number: NCT04996316

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

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.

Enrolling by Invitation

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–74 year

Sex eligibility

Female

Study type

Observational

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic Health Record Review

Other

Health record reviewed

interview

Other

Participate in interview

Media Intervention

Other

Use MammoScreen

Survey Administration

Other

Complete survey

Training and education

Other

Undergo training

Primary outcomes

  1. Uptake of MammoScreen

    Time frame: Up to 5 years

    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.

  2. 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 outcomes

  1. Rates of mammography screening referral

    Time frame: Up to 5 years

  2. Screening completed

    Time frame: Up to 5 years

    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.

  3. Mammography results

    Time frame: Up to 5 years

    Will be stratified by risk category. Will be analyzed similarly using proportions and 95% confidence intervals, and a regression model if allowed by data.

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

    Time frame: Up to 5 years

    Will be analyzed similarly using proportions and 95% confidence intervals, and a regression model if allowed by data.

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

    Time frame: Up to 5 years

  6. Number of above average risk MammoScreen users who had a genetic test done

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Oregon Health and Science University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 9, 2021
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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