Questionnaires and Cognitive Assessments Following Mammography

NCT ID: NCT03412370

Last Updated: 2019-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-27

Study Completion Date

2017-09-21

Brief Summary

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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

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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.

Conditions

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Health Status Unknown

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (questionnaires, 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.

Cognitive Assessment

Intervention Type OTHER

Complete cognitive assessments

Questionnaire Administration

Intervention Type OTHER

Complete questionnaires

Interventions

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Cognitive Assessment

Complete cognitive assessments

Intervention Type OTHER

Questionnaire Administration

Complete questionnaires

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joan Broderick, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2017-02234

Identifier Type: REGISTRY

Identifier Source: secondary_id

1B-17-2

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1B-17-2

Identifier Type: -

Identifier Source: org_study_id

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