Copy of A Human Touch

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

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

Sponsored by:	Posit Science Corporation
Information provided by:	Posit Science Corporation
ClinicalTrials.gov Identifier:	NCT00387062

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:

	Examination of the quantitative training program progression data
	Safety

Secondary Outcome Measures:

	Quality of life health assessments
	Functional outcomes assessments
	Perceived 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:

	Age 21 or older at the time of consent.
	Diagnosis of invasive breast cancer or recurrence warranting treatment with chemotherapeutic agents
	Cognitive decline, as reported by the patient, friends, or family.
	Fluent English speaker.
	Willing and able to commit to the 3-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.

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

Link

Note

If you experience symptoms of chemobrain, I strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this web site is meant to be helpful and educational, but is not a substitute for medical advice.

If you feel your medical team is not informed or supportive about chemobrain, I urge you to refer them to this web site or seek out a provider among those listed who are actively engaged in the research and writing on this complex matter.

No one should go through this alone.