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

NCT ID: NCT03674437

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 441 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-11
• Study Completion Date: 2026-09-30

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.

Conditions

Breast Cancer Survivors

Keywords

Quality of Life; Cognitive Function; 18-294

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Traditional Neurocognitive Assessments

Intervention Type: BEHAVIORAL

Traditional Neurocognitive Assessments given with pen and paper

Online Cognitive Battery (Cogsuite)

Intervention Type: BEHAVIORAL

Cognition (Cogsuite) for a battery that consists of seven measurements.

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.

Traditional Neurocognitive Assessments

Intervention Type: BEHAVIORAL

Traditional Neurocognitive Assessments given with pen and paper

Online Cognitive Battery (Cogsuite)

Intervention Type: BEHAVIORAL

Cognition (Cogsuite) for a battery that consists of seven measurements.

Healthy 21-25 year olds

Healthy participants between the ages of 21 and 25 will be administered the Cogsuite Battery remotely. These participants will not be matched to any other groups and will not be asked for their full medical histories. They will only complete the assessment only once.

Traditional Neurocognitive Assessments

Intervention Type: BEHAVIORAL

Traditional Neurocognitive Assessments given with pen and paper

Online Cognitive Battery (Cogsuite)

Intervention Type: BEHAVIORAL

Cognition (Cogsuite) for a battery that consists of seven measurements.

Interventions

Traditional Neurocognitive Assessments

Traditional Neurocognitive Assessments given with pen and paper

Intervention Type: BEHAVIORAL

Online Cognitive Battery (Cogsuite)

Cognition (Cogsuite) for a battery that consists of seven measurements.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Susan Love Research Foundation

OTHER

Sponsor Role: collaborator

ENFORMIA INC.

UNKNOWN

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Root, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

18-294

Identifier Type: -

Identifier Source: org_study_id