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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04996316
• Other study ID #: STUDY00022698
• Secondary ID: NCI-2021-06583ST
• Status: Recruiting
• Start date: September 7, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2024
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1141
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 74 Years

Eligibility

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
• Double Mastectomy

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Other:
• Electronic Health Record Review
Health record reviewed
• Interview
Participate in interview
• Media Intervention
Use MammoScreen
• Survey Administration
Complete survey
• Training and Education
Undergo training

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Agency for Healthcare Research and Quality (AHRQ), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of women with above-average risk for breast cancer identified by MammoScreen integrated with the electronic health record (EHR)		Up to 5 years
Secondary	Rates of mammography screening referral		Up to 5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of above average risk MammoScreen users who completed a genetic counseling visit		Up to 5 years
Secondary	Number of above average risk MammoScreen users who had a genetic test done		Up to 5 years