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Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Improving Cognition with group intervention
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Reduce Cognitive Complaints, improve cognitive function, post-treatment breast cancer patients

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group Intervention program

Wait-list control group

Arm Description

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.

Outcomes

Primary Outcome Measures

Cognitive function measured by neuropsychological assessment 2 months after group intervention

Secondary Outcome Measures

Full Information

First Posted
February 16, 2012
Last Updated
April 8, 2015
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Breast Cancer Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01540955
Brief Title
Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors
Official Title
Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Breast Cancer Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Reduce Cognitive Complaints, improve cognitive function, post-treatment breast cancer patients

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Intervention program
Arm Type
Experimental
Arm Title
Wait-list control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Improving Cognition with group intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive function measured by neuropsychological assessment 2 months after group intervention
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Ganz, M.D.
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors

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