Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMasonic Cancer Center, University of Minnesota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
* ≥ 18 years of age at initiation of therapy
Planning to undergo inpatient CAR-T therapy for primary malignancy
Fluent in English (written or spoken)
Disqualifiers
* 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
Trial population
Patients planning to undergo CAR-T therapy for primary malignancy recruited through the University of Minnesota.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
38 Participants
are divided into 1 treatment groupGroup A: Observational1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients completing at least 80 percent of planned SALSA administrations during post CAR-T hospitalization
Descriptive statistics will be used to summarize the feasibility of SALSA in CAR-T patients. The overall completion rate of will be calculated for each patient, as well as the pattern of completions.
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Masonic Cancer Center, University of Minnesota
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov