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A Cognitive Training Intervention for Improving Cognitive and Neurological Outcomes in Patients Undergoing Treatment for Relapsed or Refractory Multiple Myeloma or B-cell Non-Hodgkin Lymphoma

NCT07609030 · Ohio State University Comprehensive Cancer Center
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Official title
Intervention to Enhance Cognitive Augmentation and Neuroplasticity (I-CAN)
About this study
PRIMARY OBJECTIVE: I. To conduct a prospective single arm study of an Intervention to enhance Cognitive Augmentation and Neuroplasticity (I-CAN) program in 90 patients with relapsed B-cell hematologic malignancy receiving chimeric antigen receptor-T cell therapy (CAR-T). SECONDARY OBJECTIVES: I. To examine the neurocognitive change (Functional Assessment of Cancer Therapy-Cognition Perceived Cognitive Impairment \[FACT-Cog PCI\]; Montreal Cognitive Assessment \[MoCA\]) from baseline, following the I-CAN program at timepoint 2 (T2)-timepoint 5 (T5) in CAR T recipients. II. To examine the relationship of higher-grade neurotoxicity/cytokine release syndrome (CRS) with change in neurocognitive measures (FACT-Cog PCI, MoCA) from baseline, following the I-CAN program at T2-T5 in CAR T recipients. III. To examine the change in distress (anxiety and depression) and frailty (Fried Frailty Phenotype) from baseline, following the I-CAN program at T2-T5 in CAR-T recipients. IV. To determine the change in molecular markers of aging (Ohio State University \[OSU\] Senescence, epigenetic clock/DNAge, inflammatory cytokines, changes in peripheral blood T lymphocyte subsets) before and after CAR-T. V. To examine the association of molecular markers of aging with cognition and frailty (FACT-Cog PCI, Fried Frailty Phenotype) as well as other prognostic factors (e.g. age, disease, CRS/neurotoxicity) before and after CAR-T. VI. To explore the impact of the ICAN program on healthcare utilization (hospital re/admissions, emergency department visits) compared to age and diagnostic-matched historic control from baseline to T5 and examine return to work (role function/work productivity/absenteeism) at each time point, timepoint 1 (T1)-T5. OUTLINE: Patients participate in online I-CAN training sessions over approximately 2.5 hours per week for 4 weeks before and 4 weeks after CAR-T therapy for a total of 20 hours over 8 weeks. Patients also undergo collection of blood samples throughout the study. After completion of study treatment, patients are followed up at 1, 3, and 12 months post-infusion.
Eligibility criteria
Inclusion Criteria: * Patients \>= 18 years of age * Diagnosed with relapsed/refractory multiple myeloma (MM) or B-cell non-Hodgkin lymphoma (B-NHL) * Expected to receive an Food and Drug administration (FDA)-approved CAR-T cellular treatment * English literacy Exclusion Criteria: * Patients expected to live \< 6 months * Patients with major medical disorder known to affect cognition, such as stroke, encephalitis, traumatic brain injury, brain surgery * Confirmed Alzheimer disease or other dementia * Previous central nervous system (CNS) radiation * Active intrathecal therapy at time of enrollment
Study design
Enrollment target: 90 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-28
Estimated completion: 2027-12-31
Last updated: 2026-05-27
Interventions
Procedure: Biospecimen CollectionOther: Cognitive InterventionOther: Electronic Health Record ReviewOther: Survey Administration
Primary outcomes
  • Intervention to enhance cognitive augmentation and neuroplasticity (I-CAN) adherence (feasibility) (At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5))
  • Retention (12 months post-infusion, up to 14 months)
  • I-CAN satisfaction (feasibility) (At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5))
Sponsor
Ohio State University Comprehensive Cancer Center · other
With: National Institutes of Health (NIH)
Contacts & investigators
ContactThe Ohio State University Comprehensive Cancer Center · contact · OSUCCCClinicaltrials@osumc.edu · 800-293-5066
InvestigatorAshley E Rosko, MD · principal_investigator, Ohio State University Comprehensive Cancer Center
All locations (1)
Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States
A Cognitive Training Intervention for Improving Cognitive and Neurological Outcomes in Patients Undergoing Treatment for Relapsed or Refractory Multiple Myeloma or B-cell Non-Hodgkin Lymphoma · TrialPath