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  • Cancer Type: Multiple
  • Study Type: Other
  • NCT#:
  • Phase: N/A
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  • Overview

    Study Title:

    Chimeric Antigen Receptor T-Cell Therapy: Neurocognitive Effects and Patient-Reported Outcomes

    Summary:

    The purpose of this study is to assess self-reported side-effects and neurocognitive (brain, mood, and thinking) functioning among patients treated with chimeric antigen receptor T-cell (CAR-T) therapy. In order to study side-effects and functioning among people receiving CAR-T therapy, the study team will collect and compare information from participants who receive CAR-T therapy as well as from people who have no history of cancer.

    Objective:

    The goal of the current study is to better understand changes in PROs and cognition in 204 adult CAR T-cell therapy recipients (CART+) compared to 102 non-cancer controls (CA-) frequency-matched on age, biological sex, and education. Aims are as follows: Aim 1: To examine baseline differences and longitudinal changes in patient-reported outcomes and cognition in CAR T-cell therapy recipients and non-cancer controls. Aim 2: To identify demographic, contextual, and clinical risk factors associated with worse cognition in CAR T-cell therapy recipients compared to non-cancer controls. Aim 3: To determine behavioral protective factors associated with better cognition among CAR T-cell therapy recipients and non-cancer controls.

  • Inclusion Criteria

      Inclusion Criteria:
    • At least 18 years of age
    • Diagnosed with hematologic cancer (e.g.,diffuse large B-cell lymphoma, multiple myeloma),
    • Scheduled to receive CAR T cell therapy at Moffitt Cancer Center
    • Have internet access at home
    • Able to speak and read English,
    • Able to provide written informed consent.
  • Exclusion Criteria

      Exclusion Criteria:
    • Patients with documented or observable neurological disorder (e.g., Parkinson’s disease, dementia), or uncontrolled sleep disorder (e.g., sleep apnea, restless leg syndrome)

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