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

This study has been completed.
Sponsor:
Information provided by:
Posit Science Corporation
ClinicalTrials.gov Identifier:
NCT00387062
First received: October 10, 2006
Last updated: June 23, 2008
Last verified: June 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment, A Pilot Study

Resource links provided by NLM:


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

Estimated Enrollment: 50
Study Start Date: October 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387062

Locations
United States, California
Posit Science Corporation
San Francisco, California, United States, 94104
Sponsors and Collaborators
Posit Science Corporation
Investigators
Principal Investigator: Henry W Mahncke, PhD Posit Science Corporation
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00387062     History of Changes
Other Study ID Numbers: OUT-113-2005; 06140-01
Study First Received: October 10, 2006
Last Updated: June 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Posit Science Corporation:
Breast Cancer
Cognitive Impairment
Chemofog
Chemobrain
Post-chemotherapy cognitive impairment

Additional relevant MeSH terms:
Breast Neoplasms
Memory Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014