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Rehabilitation of Cognitive Changes in Breast Cancer Survivors


N/A
18 Years
69 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Rehabilitation of Cognitive Changes in Breast Cancer Survivors


Note: Any participant who reports tics can be included, however participants will be told
tics may increase during the training period.

Inclusion Criteria:



Patients

- Female breast cancer survivors who have received adjuvant chemotherapy 1-10 years
from the time of recruitment either at MSKCC or elsewhere

- Stage I, II, III breast cancer as noted in pathology reports or by clinician
judgement.

- No evidence of disease at time of screening

- Age range 18 years old through <70 years old

- Must be able speak, read and write English well enough to complete written and verbal
assessments and neurocognitive tests. The software was developed and validated in
English and are not currently available in other languages. Translation of
questionnaires into other languages would require reestablishing the reliability and
validity of these measures.

- Must demonstrate cognitive deficiency, which is defined as 1.0 standard deviations
below normative data on at least one of the pre-screen phone assessments (WAIS-III
Digit Span, Symbol Digit Modalities Test, Controlled Oral Word Association Test, Rey
Auditory Verbal Learning Test) or must have 1.0 standard deviations difference from
the pre-morbid estimate of cognitive functioning, Wide Range Achievement Test 4:
Reading subtest, and one of the pre-screen phone assessment measures.

- Must have basic computer skills such as able to turn on a computer, open the program,
login, and use a mouse.

- Participants must have the ability to upload their data via the internet. A study
laptop can be loaned out to participants who do not have a computer or the
appropriate operating systems.

Collateral Participant (if such person is available to the participant, not a requirement
of the study) Family member or friend (i.e., collateral) identified by a patient who has
at least weekly face to face contact with the patient

- Collateral person is at least 18 years of age

- Family member or friend has adequate English fluency for completion of data
collection. The surveys were designed and validated in English and are not currently
available in other languages. Translation of questionnaires into other languages
would require reestablishing the reliability and validity of these measures.

- Able to provide informed consent

Exclusion Criteria:

Patients

- History of neurological disorder with cognitive symptoms (e.g., Alzheimer's disease,
Parkinson's disease, multiple sclerosis, seizure disorder) as per self report or as
documented in the electronic medical record.

- History of mental retardation, learning disorder bipolar disorder, schizophrenia,
substance use disorder(s), or uncontrolled depression as per self report or as
documented in the medical record.

- History of Traumatic Brain Injury with > or = to 30 minutes loss of consciousness or
cognitive sequelae as per self report or as documented in the medical record.

- History of Stroke as per self report or as documented in the medical record.

- Prior history or secondary diagnosis of other cancers except for basal cell carcinoma
or melanoma treated with surgery only

- History of multiple courses of chemotherapy.

- Evidence of recurrence at time of screening

- A hearing or visual deficit that impairs the ability to use the software.

- Significant cognitive or psychiatric disturbance sufficient, in the investigator's
judgment, to preclude providing informed consent.

- Males will be excluded as only a minority of men gets breast cancer. Thus, there
would not be enough men to have equivalent groups to statistically control for
possible gender effects.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Determine the efficacy of working memory training

Outcome Description:

in breast cancer survivors based on improved performance on neuropsychological tests of working memory.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Elizabeth Ryan, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

10-105

NCT ID:

NCT01182506

Start Date:

August 2010

Completion Date:

August 2013

Related Keywords:

  • Breast Cancer
  • Cogmed Working Memory Training (CWMT)
  • cognitive
  • 10-105
  • Breast cancer survivor
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021