Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Improving Cognition with group intervention

• Registration Number: NCT01540955
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-02-29
• Study Start: 2012-04
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Intervention program	Improving Cognition with group intervention	-

Primary Outcome Measures

Name	Time	Method
Cognitive function measured by neuropsychological assessment 2 months after group intervention	2 months

Trial Locations

Locations (1)

UCLA; 🇺🇸 Los Angeles, California, United States