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Questionnaires and Cognitive Assessments Following Mammography

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ClinicalTrials.gov Identifier: NCT03412370
Recruitment Status : Terminated (Insufficient Accrual)
First Posted : January 26, 2018
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Health Status Unknown Other: Cognitive Assessment Other: Questionnaire Administration

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.


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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Symptom Tracking in Women Following Mammography
Actual Study Start Date : July 27, 2017
Actual Primary Completion Date : September 21, 2017
Actual Study Completion Date : September 21, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Cognitive Assessment
Complete cognitive assessments

Other: Questionnaire Administration
Complete questionnaires




Primary Outcome Measures :
  1. Number of patients invited who agree to participate [ Time Frame: Up to 2 years ]
    Number of patients invited will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women who have just completed a mammography
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412370


Locations
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United States, California
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Joan Broderick, Ph.D. University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03412370     History of Changes
Other Study ID Numbers: 1B-17-2
NCI-2017-02234 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1B-17-2 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No