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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03412370
Other study ID # 1B-17-2
Secondary ID NCI-2017-022341B
Status Terminated
Phase
First received
Last updated
Start date July 27, 2017
Est. completion date September 21, 2017

Study information

Verified date January 2019
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date September 21, 2017
Est. primary completion date September 21, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cognitive Assessment
Complete cognitive assessments
Questionnaire Administration
Complete questionnaires

Locations

Country Name City State
United States USC / Norris Comprehensive Cancer Center Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients invited who agree to participate Number of patients invited will be reported. Up to 2 years
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