Clinical trial NCT04996316: MammoScreen Breast Cancer Risk Assessment and Decision Aid for Breast Cancer Screening and Referrals
Official title: Implementing USPSTF Recommendations for Breast Cancer Screening and Prevention by Integrating Clinical Decision Support Tools With the Electronic Health Record
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Oregon Health and Science University
First posted: 2021-08-09
Enrollment: 1141
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between the ages of 40 and 74

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.

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.

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

Primary outcomes:
measure: Uptake of MammoScreen
timeFrame: Up to 5 years
measure: Number of women with above-average risk for breast cancer identified by MammoScreen integrated with the electronic health record
timeFrame: Up to 5 years
Secondary outcomes:
measure: Rates of mammography screening referral
timeFrame: Up to 5 years
measure: Screening completed
timeFrame: Up to 5 years
measure: Mammography results
timeFrame: Up to 5 years
measure: Number of above average risk MammoScreen users who received a genetic counseling referral
timeFrame: Up to 5 years
measure: Number of above average risk MammoScreen users who completed a genetic counseling visit
timeFrame: Up to 5 years
measure: Number of above average risk MammoScreen users who had a genetic test done
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: Department of Medical Informatics and Clinical Epidemiology, OHSU Knight Cancer Institute
name: Karen Eden, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: