Clinical trial NCT01182506: Rehabilitation of Cognitive Changes in Breast Cancer Survivors
Official title: Rehabilitation of Cognitive Changes in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Cogmed Working Memory Training (CWMT)
cognitive
10-105
Breast cancer survivor
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: MARTELL FOUNDATION
First posted: 2010-08-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test a memory training program for breast cancer survivors who have problems with memory after receiving chemotherapy. Since breast cancer survivors have been reported to have trouble with their memory, a program to help these problems is important. Studies have shown that a 5-week software training program improved memory in pediatric cancer survivors and other disorders like stroke, but it has not been tested for breast cancer survivors. This study will see if breast cancer survivors can improve their memory and attention problems by using either one of two software versions of the program. One version is called Cogmed Working Memory Training, and the other is a comparison version of the software that has the same exercises but is less difficult. People who decide to participate in the study will be randomly given one of the two versions.


Eligibility criteria: 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.

Primary outcomes:
measure: Determine the efficacy of working memory training
timeFrame: 2 years
Secondary outcomes:
measure: Test whether or not working memory training in breast cancer survivors is associated with greater gains in the software's "Improvement Index".
timeFrame: 2 years
measure: Investigate whether breast cancer survivors perceive functional improvement following working memory training.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Elizabeth Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: