Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment

This study is currently recruiting patients.
Verified by Posit Science Corporation October 2006

Purpose

The investigators hypothesize that continuous active interaction with environments that are demanding to sensory, cognitive, and motor systems, together with imbedded rewards for successful performance, will help improve memory and cognitive functioning in patients suffering from “chemobrain”.
Condition Intervention Phase
Breast Cancer
Cognitive Symptoms
Memory Disorders
 Device: Computer-based Cognitive Training
Phase I

Study Type: Interventional
Study Design: Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment, A Pilot Study

Further study details as provided by Posit Science Corporation:
Primary Outcome Measures: 
bulletExamination of the quantitative training program progression data
bulletSafety

Secondary Outcome Measures: 
bulletQuality of life health assessments
bulletFunctional outcomes assessments
bulletPerceived stress assessments

Total Enrollment:  20

Study start: October 2006;  Expected completion: June 2007

Breast cancer is the most common malignancy in women in the United States, with an estimated 211,240 new cases of invasive breast cancer diagnosed among women, and 1,700 diagnosed in men, in 2005. While cure rates have improved significantly, chemotherapy for breast cancer is associated with a number of negative side effects. One of which is a deficit in cognitive function, a condition commonly referred to as “chemobrain”. While the debate about cognitive decline being a result of chemotherapy is still ongoing, there is clear evidence of cognitive decline in women with breast cancer post-chemotherapy. Cognitive decline is often reported to affect memory, attention, executive functioning and information processing speed.

Studies suggest that incidence of “chemobrain” ranges from 17% – 75% in women who have undergone chemotherapy.This cognitive impairment affects quality of life by impacting patients’ ability to concentrate, make decisions and to fulfill family, career, and community responsibilities.

Although there is uncertainty about the mechanisms that can lead to this cognitive decline, there is a pressing need to identify interventions that will alleviate its symptoms and help breast cancer survivors recover their cognitive functioning and resume their roles and activities at the pre-cancer level.

Brain plasticity refers to the brain’s capacity for physical and functional change; it is this capacity that explains how experience induces learning throughout life. On the basis of a growing body of literature in the fields of psychophysics, neurology, neuropsychology, and brain plasticity, we hypothesize that the brain processing machinery can be refined, elaborated, and strengthened through rigorous training and learning. The purpose of this study is to investigate if such training can improve cognitive functioning.

We hypothesize that continuous active interaction with environments that are demanding to sensory, cognitive, and motor systems, together with imbedded rewards for successful performance will help improve memory and cognitive functioning in patients suffering from “chemobrain”.

Eligibility

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

bulletAge 21 or older at the time of consent.
bulletDiagnosis of invasive breast cancer or recurrence warranting treatment with chemotherapeutic agents
bulletCognitive decline, as reported by the patient, friends, or family.
bulletFluent English speaker.
bulletWilling and able to commit to the 3-month time requirement of the entire study period.
bulletWilling to provide informed consent
bulletWilling to participate in training of the program.
bulletAgrees to weekly contact

Exclusion Criteria:

bullet Severe hearing impairments that would:

bulletlimit the ability to receive instructions and support; and
bullethinder performance on the computer training program.
bulletSelf-report of untreated Axis I or II disorders (with the exception of depression, anxiety disorders, and panic disorders).
bullet Self-report of current diagnosis or history of major neurological illness including, but not limited to:

bulletAlzheimer’s disease
bulletParkinson’s disease
bulletMultiple sclerosis
bulletAmyotrophic lateral sclerosis
bulletHistory of a stroke, transient ischemic attack (TIA) or traumatic brain injury within the past year; or lifetime history of stroke, TIA, or traumatic brain injury that has left residual expressive or receptive language problems.
bulletSelf-report of fibromyalgia or symptoms of tremor severe enough to prevent the use of a computer mouse or other pointing device.
bulletUnwillingness to complete the required assessments.
bulletPatient is not capable of giving informed consent or unable to comprehend and/or follow instructions.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00387062

 

Sarah Kim      415-394-3100  Ext. 7671    sarah.kim@positscience.com

United States, California
      Posit Science Corporation, San Francisco,  California,  94104,  United States; Recruiting
Sarah Kim  415-394-3100  Ext. 7671    sarah.kim@positscience.com 
Cate Stasio  415-394-3100  Ext. 3546    cate.stasio@positscience.com 
Henry W Mahncke, PhD,  Principal Investigator

Study chairs or principal investigators

Henry W Mahncke, PhD,  Principal Investigator,  Posit Science Corporation   

More Information

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