Early Identification of Cognitive Side-Effects of Immunotherapy
Masonic Cancer Center, University of Minnesota
Summary
This clinical trial evaluates the use of a tool kit, Stress, Affect, Language and Speech Analysis (SALSA), for early identification of cognitive side effects of immunotherapy compared to the standard of care assessment.
Description
PRIMARY OBJECTIVES: I. To investigate the use of a toolkit for automated administration and scoring of cognitive tests (Stress, Language and Speech Analysis, or SALSA) in adult cancer patients who are treated with commercial chimeric antigen receptor T cell therapy (CAR-T) products at University of Minnesota and are at risk of developing immune effector cell-associated neurotoxicity syndrome (ICANS). OUTLINE: This is an observational study. Patients complete SALSA assessment and ICE assessments on study. Patients also have their medical records reviewed on study.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * \* ≥ 18 years of age at initiation of therapy * Planning to undergo inpatient CAR-T therapy for primary malignancy * Fluent in English (written or spoken) Exclusion Criteria: * \* Subjects with speech or hearing impediment that would make them unable to be assessed with SALSA * Subjects with diagnosed cognitive impairment prior to CAR-T therapy * Unwilling or unable to sign voluntary written consent
Interventions
- OtherNon-Interventional Study
Non-interventional study
Location
- University of Minnesota/Masonic Cancer CenterMinneapolis, Minnesota