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Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors

This study is currently recruiting participants.
Verified January 2013 by Jonsson Comprehensive Cancer Center
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01540955
First received: February 16, 2012
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Behavioral: Improving Cognition with group intervention
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Cognitive function measured by neuropsychological assessment 2 months after group intervention [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group Intervention program Behavioral: Improving Cognition with group intervention
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.
No Intervention: Wait-list control group
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540955

Contacts
Contact: Barbara Kahn-Mills 310 825 2520

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Barbara Kahn-Mills     310-825-2520        
Principal Investigator: Patricia Ganz, M.D.            
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Breast Cancer Research Foundation
Investigators
Principal Investigator: Patricia Ganz, M.D. Jonsson Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01540955     History of Changes
Other Study ID Numbers: 11-003446, JCCCID256
Study First Received: February 16, 2012
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
Reduce Cognitive Complaints
improve cognitive function
post-treatment breast cancer patients

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013