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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674437
Recruitment Status : Enrolling by invitation
First Posted : September 17, 2018
Last Update Posted : July 30, 2020
Sponsor:
Collaborator:
Dr. Susan Love Research Foundation
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date September 12, 2018
First Posted Date September 17, 2018
Last Update Posted Date July 30, 2020
Actual Study Start Date September 11, 2018
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2018)
validate computerized cognitive measures (Cogsuite Battery) [ Time Frame: 2 years ]
These will include 14 correlations, across the two cohorts and 7 tests (Modified Attention Network Test, N-Back Test, Stop-signal Test, Mental Rotation Test, Verbal Fluency Test, Motor Function Test, and Processing Speed Test).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Breast Cancer Survivors
Intervention
  • Behavioral: Traditional Neurocognitive Assessments
    Traditional Neurocognitive Assessments given with pen and paper
  • Behavioral: Online Cognitive Battery (Cogsuite)
    Cognition (Cogsuite) for a battery that consists of seven measurements.
Study Groups/Cohorts
  • Breast Cancer Survivors
    Each main cohort has 2 sub-groups: One sub-group in each main cohort will complete the traditional neurocognitive assessments and the Cogsuite Assessment at the MSK Counseling Center, and the other sub-group will complete the Cogsuite Assessment off-site, on their own computers, in a quiet space that is free of distractions.
    Interventions:
    • Behavioral: Traditional Neurocognitive Assessments
    • Behavioral: Online Cognitive Battery (Cogsuite)
  • Healthy Controls
    Each main cohort has 2 sub-groups: One sub-group in each main cohort will complete the traditional neurocognitive assessments and the Cogsuite Assessment at the MSK Counseling Center, and the other sub-group will complete the Cogsuite Assessment off-site, on their own computers, in a quiet space that is free of distractions.
    Interventions:
    • Behavioral: Traditional Neurocognitive Assessments
    • Behavioral: Online Cognitive Battery (Cogsuite)
  • Healthy 21-25 year olds
    Healthy participants between the ages of 21 and 25 will be administered the Cogsuite Battery remotely (once only).
    Interventions:
    • Behavioral: Traditional Neurocognitive Assessments
    • Behavioral: Online Cognitive Battery (Cogsuite)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: July 28, 2020)
480
Original Estimated Enrollment
 (submitted: September 12, 2018)
280
Estimated Study Completion Date September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Breast Cancer survivors
Ages 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03674437
Other Study ID Numbers 18-294
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Dr. Susan Love Research Foundation
Investigators
Principal Investigator: James Root, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date July 2020