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

Primary Purpose

Breast Cancer, Cognitive Symptoms, Memory Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computer-based Cognitive Training
Sponsored by
Posit Science Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Cognitive Impairment, Chemofog, Chemobrain, Post-chemotherapy cognitive impairment

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Posit Science Corporation

Outcomes

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

Full Information

First Posted
October 10, 2006
Last Updated
June 23, 2008
Sponsor
Posit Science Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00387062
Brief Title
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

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Posit Science Corporation

4. Oversight

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cognitive Symptoms, Memory Disorders
Keywords
Breast Cancer, Cognitive Impairment, Chemofog, Chemobrain, Post-chemotherapy cognitive impairment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Computer-based Cognitive Training
Primary Outcome Measure Information:
Title
Examination of the quantitative training program progression data
Title
Safety
Secondary Outcome Measure Information:
Title
Quality of life health assessments
Title
Functional outcomes assessments
Title
Perceived stress assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry W Mahncke, PhD
Organizational Affiliation
Posit Science Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Posit Science Corporation
City
San Francisco
State/Province
California
ZIP/Postal Code
94104
Country
United States

12. IPD Sharing Statement

Citations:
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Citation
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Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment

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