Cognitive Rehabilitation Group Intervention for Breast Ca... | NCT01540955

Studies
Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors

NCT01540955

Sponsor

Jonsson Comprehensive Cancer Center

Status

Completed

Last Update Posted

Apr 10, 2015Estimated

Enrollment

48Actual

Phase

Phase 2

Conditions

Breast Cancer

Interventions

Improving Cognition with group intervention

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
JCCCID256	Other Identifier	Jonsson Comprehensive Cancer Center

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Feb 16, 2012

First Submission Date that Met QC Criteria

Feb 28, 2012

First Posted Date

Feb 29, 2012Estimated

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

Apr 8, 2015

Last Update Posted Date

Apr 10, 2015Estimated

Name	Class
Breast Cancer Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

There are over 2 million breast cancer survivors in the US today. Along with extended survival, many women experience short and long-term after effects of treatment, which may decrease their quality of life and contribute to other health problems. Cognitive complaints---difficulties with memory, concentration, and planning-are commonly reported after adjuvant treatments for breast cancer. This study is designed to test the efficacy of a 5 week group-based cognitive rehabilitation intervention on improving cognitive complaints and test performance, in comparison to women who will receive the same intervention at a later time (wait-list control). Women will also have an EEG test performed before and after the intervention program to see if improvements in cognitive complaints and performance can be documented by examining the EEG.

Detailed Description

Previous pilot work (non-randomized, pre-post design) has shown that this intervention was effective in improving post-intervention cognitive complaints and neuropsychological (NP) test performance. Because practice effects may influence NP performance, it is important to compare the intervention participants to women who are not exposed to the intervention. Thus, this randomized controlled trial will compare the active intervention to a control group of patients who will receive the intervention at a delayed time point. The primary outcomes are improvements in cognitive complaints and NP test performance 2 months after completion of the intervention program. Quantitative EEG (QEEG) measurements will be used as a secondary exploratory endpoint to see if this may be an effective biomarker of cognitive performance.

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group Intervention program	Experimental		Behavioral: Improving Cognition with group intervention
Wait-list control group	No Intervention	The wait-list-control group will also be able to participate in the group intervention, but not until after all the study visits have been completed.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Improving Cognition with group intervention	Behavioral	Participants attend 5 weekly group sessions that are 2 hours each, delivered by a trained therapist. Sessions focus on specific aspects of attention, memory, multi-tasking and encoding. Homework assignments are practiced between classes. Goals are set for improved functioning.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive function measured by neuropsychological assessment 2 months after group intervention		2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 21-65 years
stage I, II, III breast cancer diagnosis within the past 18 months to 5 years
currently disease free, but may be on endocrine therapy
with evidence of need of cognitive therapeutic intervention, as demonstrated by mild or greater cognitive deficiencies on an objective screening measure
reads and writes English
able to give informed consent
willing and able to attend 5 weekly group sessions and participate in pre and post-evaluation that will take place on the UCLA campus

Exclusion Criteria:

evidence of uncontrolled depression

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patricia Ganz, M.D.	Jonsson Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA		Los Angeles	California	90095	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided