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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04996316
Other study ID # STUDY00022698
Secondary ID NCI-2021-06583ST
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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