Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 2/7/2015 |
| Start Date: | March 2012 |
| Contact: | Barbara Kahn-Mills |
| Phone: | 310 825 2520 |
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.
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.
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.
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.
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
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