Clinical trial NCT00387062: Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment
Official title: Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment, A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Cognitive Symptoms
Memory Disorders
Keywords: Breast Cancer
Cognitive Impairment
Chemofog
Chemobrain
Post-chemotherapy cognitive impairment
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
First posted: 2006-10-12
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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".

Detailed description: 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 criteria: Inclusion Criteria:

* Age 21 or older at the time of consent.
* Diagnosis of invasive breast cancer or recurrence warranting treatment with chemotherapeutic agents in the past 5 years.
* Cognitive decline, as reported by the patient, friends, or family.
* Fluent English speaker.
* Willing and able to commit to the 6-month time requirement of the entire study period.
* Willing to provide informed consent
* Willing to participate in training of the program.
* Agrees to weekly contact

Exclusion Criteria:

* Severe hearing impairments that would:

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

  * Alzheimer's disease
  * Parkinson's disease
  * Multiple sclerosis
  * Amyotrophic lateral sclerosis
* History 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.
* Self-report of fibromyalgia or symptoms of tremor severe enough to prevent the use of a computer mouse or other pointing device.
* Unwillingness to complete the required assessments.
* Patient is not capable of giving informed consent or unable to comprehend and/or follow instructions.

Primary outcomes:
measure: Examination of the quantitative training program progression data
measure: Safety
Secondary outcomes:
measure: Quality of life health assessments
measure: Functional outcomes assessments
measure: Perceived stress assessments
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Posit Science Corporation
state: California
Study officials:
affiliation: Posit Science Corporation
name: Henry W Mahncke, PhD
role: PRINCIPAL_INVESTIGATOR
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