Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Cognitive function measured by neuropsychological assessment 2 months after group intervention
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group Intervention program
Intervention: Improving Cognition with group intervention (Behavioral)
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.
Outcomes
Primary Outcomes
Cognitive function measured by neuropsychological assessment 2 months after group intervention
Time Frame: 2 months
Secondary Outcomes
No secondary outcomes reported