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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-03016 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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This clinical trial evaluates whether an online cognitive training intervention (Intervention to enhance Cognitive Augmentation and Neuroplasticity [I-CAN]), delivered before and after treatment with chimeric antigen receptor T-cell therapy, works to improve cognitive and neurological outcomes in patients with multiple myeloma or B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Cancer treatment can have significant short and long-term side effects, including cognitive and neurological side effects such as impairments in attention, memory, language, and executive function. The I-CAN program is a form of cognitive training. Cognitive training is a therapeutic approach designed to improve and restore cognitive functioning, based on the brain's ability to reorganize and form new neural connections to accomplish tasks. I-CAN provides five core elements necessary for training the brain to create new neural connections including speed of processing, accuracy of processing, adaptivity, generalizability, and engagement. The I-CAN intervention, when delivered before and after therapy, may help reduce the cognitive side effects of treatment in patients with relapsed or refractory multiple myeloma or B-cell non-Hodgkin lymphoma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (I-CAN) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intervention to enhance cognitive augmentation and neuroplasticity (I-CAN) adherence (feasibility) | Descriptive statistics will be used to examine adherence, defined as the percent completion of I-CAN cognitive training before and after infusion. | At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5) |
| Retention | Descriptive statistics will be used to examine retention, defined as % follow-up assessments completed. | 12 months post-infusion, up to 14 months |
| I-CAN satisfaction (feasibility) | Descriptive statistics will be used to examine acceptability, defined as % satisfaction on Client Satisfaction Questionnaire. | At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Assessment of Cancer Therapy-Cognition Perceived Cognitive Impairment (FACT-Cog PCI) | Descriptive statistics and trend plots will be used to examine the FACT-Cog PCI scores over time. Linear mixed models (LMM) for repeated measures will be used to model each neurocognitive measure (FACT-Cog-PCI scores) as a linear function of fixed-effect of time, adjusting for within-subject clustering from repeated measures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center | Contact | 800-293-5066 | OSUCCCClinicaltrials@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ashley E Rosko, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Cognitive Intervention | Other | Participate in I-CAN training sessions |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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| At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5) |
| Change in Montreal Cognitive Assessment (MoCA) | Descriptive statistics and trend plots will be used to examine the MoCA scores over time. LMM for repeated measures will be used to model each neurocognitive measure (MoCA scores) as a linear function of fixed-effect of time, adjusting for within-subject clustering from repeated measures. | At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5) |
| Change in depression | Evaluated by 20-item Center for Epidemiological Studies Depression Scale. Descriptive statistics and trend plots will be used to examine changes over time. LMM for repeated measures will be used to model each outcome as a linear function of fixed-effect of time, adjusting for within-subject clustering from repeated measures. | At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5) |
| Change in anxiety | Evaluated by 8-item Patient-Reported Outcomes Measurement Information System Short Form version1.0 - Anxiety 8a. Descriptive statistics and trend plots will be used to examine changes over time. LMM for repeated measures will be used to model each outcome as a linear function of fixed-effect of time, adjusting for within-subject clustering from repeated measures. | At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5) |
| Change in frailty | Evaluated using Fried's frailty phenotype. Descriptive statistics and trend plots will be used to examine changes over time. LMM for repeated measures will be used to model each outcome as a linear function of fixed-effect of time, adjusting for within-subject clustering from repeated measures. | At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5) |
| Healthcare utilization (Number of ER visits) | Number of ER visits for each participant will be assessed at each time point. Data will be collated by review of medical records. | Up to 14 months |
| Healthcare utilization (Hospital admissions/readmissions) | Number of hospital admissions / readmissions for each participant will be assessed at each time point. Data will be collated by review of medical records. | Up to 14 months |
| Healthcare utilization (Length of Hospital Stay) | Length of hospital stay for each participant admitted to the hospital will be assessed at each time point. Data will be collated by review of medical records. | Up to 14 months |
| Return to function | Return to work compared to published data will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (physical functioning, social functioning, role functioning). | Up to 14 months |
| Direct and indirect costs | Economic evaluation of direct medical costs of healthcare utilization and indirect costs of age-specific work ability/productivity gains/losses. | Up to 14 months |
| Income changes due to changes in work productivity | Income changes due to changes in work productivity will be estimated using annual salaries calculated based on educational attainment-matched national averages obtained from Current Population Survey Annual Social and Economic Supplements conducted by the United States Census Bureau. | Up to 14 months |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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