Questionnaires and Cognitive Assessments Following Mammography

Terminated

• Conditions: Health Status Unknown
• Interventions: Other: Cognitive Assessment; Other: Questionnaire Administration

• Registration Number: NCT03412370
• Lead Sponsor: University of Southern California

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-07-27
• Primary Completion: 2017-09-21
• Study Completion: 2017-09-21
• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-26
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-23
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (questionnaires, cognitive assessment)	Cognitive Assessment	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.
Observational (questionnaires, cognitive assessment)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Number of patients invited who agree to participate	Up to 2 years	Number of patients invited will be reported.

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States