Clinical trial NCT03674437: Evaluation of an Online, Remote Cognitive Battery for Use in Cancer Survivorship
Official title: Evaluation of an Online, Remote Cognitive Battery for Use in Cancer Survivorship
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer Survivors
Keywords: Quality of Life
Cognitive Function
18-294
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Dr. Susan Love Research Foundation
name: ENFORMIA INC.
First posted: 2018-09-17
Enrollment: 441
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSK patients will be recruited through the survivorship clinics after having been identified via a Dataline query and/or weekly clinic schedules or through direct referrals from a member of the patient"s treatment team.

Brief summary: 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.


Eligibility criteria: 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 (excluding gabapentin and including but not limited to antidepressants, and anxiolytics), on a daily basis 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 CRC 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, female
* As per medical record or self-report, age 40-65 at time of assessment
* 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 10 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 medical record or self-report, female
* As per medical record or self-report, age 40-65 at time of assessment
* As per self-report, no history of cancer except non-melanoma/basal cell skin cancer/squamous cell skin carcinoma, and at the discretion of the PI, early stage secondary cancer diagnoses treated only with surgery (for example, endometrial or cervical cancer)

For Healthy 21-25 year old Group:

* As per medical record or self-report, age 21-25 at time of assessment
* As per self-report, no history of cancer except non-melanoma/basal cell skin cancer/squamous cell skin carcinoma, and at the discretion of the PI, early stage secondary cancer diagnoses treated only with surgery (for example, endometrial or cervical cancer)

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 resulting in a structural lesion on neuropsych imaging, persistent cognitive difficulties impacting work or daily life or required cognitive rehabilitation.
* 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, except non-melanoma/basal cell skin cancer/squamous cell skin carcinoma and, at the discretion of the PI, early stage secondary cancer diagnoses treated only with surgery (for example, endometrial or cervical cancer)

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.

Primary outcomes:
measure: validate computerized cognitive measures (Cogsuite Battery)
timeFrame: 2 years
Secondary outcomes:
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: James Root, PhD
role: PRINCIPAL_INVESTIGATOR
References: