Evaluation of an Online, Remote Cognitive Battery for Use in Cancer Survivorship



Status:Enrolling by invitation
Healthy:No
Age Range:40 - 65
Updated:11/24/2018
Start Date:September 11, 2018
End Date:September 2020

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The purpose of this study is to measure changes in cognitive (mental) function in cancer
survivors using a brief, reliable, game-like set of tests that can be completed outside the
clinic, as an alternative to traditional neurocognitive assessments. This set of computerized
tests, the Cogsuite Assessment, is expected to improve our ability to identify cognitive
impairments in people who have been treated for cancer, so that we can (1) learn more about
which cognitive functions are affected by cancer treatment, and (2) guide that treatment more
effectively.


Inclusion Criteria:

For All Participants:

- As per medical record or self-report,Female

- As per medical record or self-report,Age 40-65 at time of assessment

- Score of < 11 on the Blessed Orientation-Memory-Concentration Test (BOMC)

- As per self-report, If currently taking psychoactive medications (including but not
limited to antidepressants, and anxiolytics), dose must have been stable for at least
two months prior to enrollment.

- English fluent (as per self-reported fluency of "very well")** ** Language
verification: For both patients and controls, prior to enrollment, all will be asked
the following two questions by an RSA to verify English fluency necessary for
participation in the study:

1. How well do you speak English? (must respond "Very well" when given the choices
of Very well, Well, Not well, Not at all, Don‟t know, or Refused)

2. What is your preferred language for healthcare? (must respond English)

For Patients:

- As per medical record or self-report, history of AJCC stages 0-3 breast cancer

- As per medical record or self-report, greater than six months post-treatment and
within 1.5 years of treatment completion (Note: "post-treatment" refers to completion
of surgery, radiation, and/or chemotherapy; a patient who is post-treatment but is on
endocrine therapy is still eligible to participate.)

For Healthy Controls:

- As per self-report, no history of cancer except non-melanoma/basal cell skin
cancer/squamous cell skin carcinoma

Exclusion Criteria:

For All Participants:

- As per medical record or self-report, diagnosis of neurodegenerative disorder that
affects cognitive function (e.g. Alzheimer‟s disease, Parkinson‟s disease, Multiple
Sclerosis, Dementia, Seizure Disorders, etc.).

- As per medical record or self-report, history of stroke or head injury requiring visit
to the emergency room or hospitalization

- As per self-report, fine motor/motor impairments that interfere with participant‟s
ability to use a keyboard.

- As per medical record or self-report, a diagnosis of a Schizophrenia Spectrum
Disorder, substance use disorder, Bipolar Disorder or Schizotypal personality
disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform
disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, and
Attenuated Psychotic Disorder.

- As per medical record or self-report, visual or auditory impairment that would
preclude ability to complete the assessments (e.g. history of significant macular
degeneration or being unable to correct hearing with hearing aids)

- As per self-report, use of methotrexate (Amethopterin, Rhematrex, Trexall) or
rituximab (Rituxan) for rheumatoid arthritis, psoriasis or Crohn‟s disease, or
cyclophosphamide (Cytoxan, Neosar) for Lupus.

For Patients only:

- As per medical record or self-report history of another type of cancer or more than
one previous breast cancer diagnosis, except non-melanoma/basal cell skin
cancer/squamous cell skin carcinoma

For all remote administrations:

- Minimum Hardware/Software Requirements*:

- Processor: Intel Core i3 Processer or greater

- Memory: 4GB RAM or greater

- Operating System: Recent version of Windows or OS X

- Browser: Google Chrome version 64 or higher

- Internet Speed: 1.5 Mbps recommended

- As per self-report, a quiet space (home or office, door closed) to complete the
assessments

- Enformia Cognition will provide a web URL (https://www.cogsuite.com/testme) that
participants can use to check if they have the minimum requirements. The URL will
clearly state if the user has adequate hardware using green and red text and
symbols. The test URL will also return a short 5 sequence numeric validation code
(xx-xxx) for each browser checked. The validation code will allow Enformia to
lookup the specific hardware that was tested. Research Associates can direct
prospects to the test web URL during their phone screen.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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mi
from
New York, NY
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