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Observational Study of Cognitive Side Effects from Immunotherapy

This observational study is looking at how well a toolkit called SALSA (Stress, Affect, Language and Speech Analysis) can identify early cognitive (thinking and memory) side effects in people receiving CAR-T cell therapy for blood cancers or solid tumors. Researchers want to see if SALSA is better than standard methods at catching these side effects. You might be able to join if you are 18 or older, fluent in English, and planning to receive CAR-T therapy for your cancer. The study will measure the proportion of patients who complete at least 80% of their planned SALSA assessments during their hospital stay after CAR-T therapy, with results expected at 18 months. This study is currently unclear on its recruitment status.

Study design
This is an observational study with a planned enrollment of 38 participants. It is not a randomized study, meaning participants will not be assigned to different treatment groups.
What's involved
You would complete SALSA and ICE assessments, and your medical records would be reviewed. The duration of these activities is not specified.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 18 months, suggesting a follow-up period of at least that long.

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NCT06414278

Evaluation of Early Identification of Cognitive Side Effects of Immunotherapy

Recruiting
Not specifiedAges 18+Observational
Masonic Cancer Center, University of Minnesota
~38 participants
Updated 2026-01-13 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients completing at least 80 percent of planned SALSA administrations during post CAR-T hospitalization
Measured over 18 months

Conditions

Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm

Explore related trials

Hematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Veronika Bachanova · PRINCIPAL_INVESTIGATOR · Masonic Cancer Center, University of Minnesota

Who to contact

Veronika Bachanova
[email protected]
612-625-5469
Email the study team

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Eligibility criteria

Inclusion

\* ≥ 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

\* 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

What this trial measures

  • Proportion of patients completing at least 80 percent of planned SALSA administrations during post CAR-T hospitalization18 months

    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.