Questionnaires and Cognitive Assessments Following Mammog... | NCT03412370

Studies
Questionnaires and Cognitive Assessments Following Mammography

NCT03412370

Sponsor

University of Southern California

Status

Terminated

Last Update Posted

Jan 25, 2019Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Health Status Unknown

Interventions

Cognitive Assessment
Questionnaire Administration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
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		View source

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient Accrual

Expanded Access Info

Start Date

Jul 27, 2017Actual

Primary Completion Date

Sep 21, 2017Actual

Completion Date

Sep 21, 2017Actual

First Submitted Date

Jan 19, 2018

First Submission Date that Met QC Criteria

Jan 19, 2018

First Posted Date

Jan 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2019

Last Update Posted Date

Jan 25, 2019Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 Other: Questionnaire Administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Assessment	Other	Complete cognitive assessments	Observational (questionnaires, cognitive assessment)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients invited who agree to participate	Number of patients invited will be reported.	Up to 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Women who have just completed a mammography

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joan Broderick, Ph.D.	University of Southern California	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
USC / Norris Comprehensive Cancer Center		Los Angeles	California	90033	United States

Intervention Browse Module

MeSH Terms

ID	Term
D000073216	Mental Status and Dementia Tests

Ancestor Terms

ID	Term
D009483	Neuropsychological Tests
D011581	Psychological Tests
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided