NCT03412370

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

January 19, 2018

Last Update Submit

January 23, 2019

Conditions

Health Status Unknown

Outcome Measures

Primary Outcomes (1)

  • Number of patients invited who agree to participate

    Number of patients invited will be reported.

    Up to 2 years

Study Arms (1)

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 AssessmentOther: Questionnaire Administration

Interventions

Cognitive AssessmentOTHER

Complete cognitive assessments

Observational (questionnaires, cognitive assessment)
Questionnaire AdministrationOTHER

Complete questionnaires

Observational (questionnaires, cognitive assessment)

Eligibility Criteria

Age21 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who have just completed a mammography

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Interventions

Mental Status and Dementia Tests

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Joan Broderick, Ph.D.

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

January 26, 2018

Study Start

July 27, 2017

Primary Completion

September 21, 2017

Study Completion

September 21, 2017

Last Updated

January 25, 2019

Record last verified: 2019-01

Locations

US(1)