Questionnaires and Cognitive Assessments Following Mammography

University of Southern California

Status: Terminated

Conditions: Health Status Unknown

Treatments: Other: Cognitive Assessment; Other: Questionnaire Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03412370

NCI-2017-02234 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

1B-17-2 (Other Identifier)

Details and patient eligibility

About

This pilot research trial studies how well questionnaires and cognitive assessments work in tracking patient symptoms following mammography. Gathering information over time through questionnaires and cognitive tests about symptoms patients may experience after a mammogram may help doctors understand the cause of these symptoms.

Full description

PRIMARY OBJECTIVES:

I. To determine the feasibility of Internet-based cognitive assessments as preliminary data prior to larger clinical trial.

OUTLINE:

Patients complete questionnaires and cognitive assessments over 45-60 minutes within 3 weeks following mammography and at about 3 months in patients for whom biopsy is not required, before biopsy and at about 3 months in patients for whom biopsy is required, and at 4-6 weeks after first chemotherapy infusion in patients receiving chemotherapy.

Enrollment: 6 patients

Sex: Female

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Mammography Breast Imaging Reporting and Data System (BI-RAD) 4-5; or BI-RAD 1-2
• Fluent in English
• Access to Internet
• Ability to understand and the willingness to sign a written informed consent

Exclusion criteria

• Prior abnormal mammography
• Prior cancer diagnosis
• Prior treatment with chemotherapy

Trial design

6 participants in 1 patient group

Observational (questionnaires, cognitive assessment)

Description:

Patients complete questionnaires and cognitive assessments over 45-60 minutes within 3 weeks following mammography and at about 3 months in patients for whom biopsy is not required, before biopsy and at about 3 months in patients for whom biopsy is required, and at 4-6 weeks after first chemotherapy infusion in patients receiving chemotherapy.

Treatment:

Other: Questionnaire Administration

Other: Cognitive Assessment