Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCLA

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Improving Cognition with group intervention

Behavioral

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.

Primary outcomes

Cognitive function measured by neuropsychological assessment 2 months after group intervention

Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

Breast Cancer Research Foundation

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Feb 29, 2012
Registry last updated: Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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