Breast Cancer Clinical Trial

Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors

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.

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Full 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.

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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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

48

Study ID:

NCT01540955

Recruitment Status:

Completed

Sponsor:

Jonsson Comprehensive Cancer Center

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There is 1 Location for this study

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UCLA
Los Angeles California, 90095, United States

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Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

48

Study ID:

NCT01540955

Recruitment Status:

Completed

Sponsor:


Jonsson Comprehensive Cancer Center

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