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
19 de mayo de 2026 actualizado por: Ashley Rosko, Ohio State University Comprehensive Cancer Center
Intervention to Enhance Cognitive Augmentation and Neuroplasticity (I-CAN)
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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
90
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: The Ohio State University Comprehensive Cancer Center
- Número de teléfono: 800-293-5066
- Correo electrónico: OSUCCCClinicaltrials@osumc.edu
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Reclutamiento
- Ohio State University Comprehensive Cancer Center
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Investigador principal:
- Ashley E. Rosko, MD
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Contacto:
- Ashley E. Rosko, MD
- Número de teléfono: 614-688-7397
- Correo electrónico: Ashley.Rosko@osumc.edu
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Supportive care (I-CAN)
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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Someterse a la recolección de muestras de sangre.
Otros nombres:
Estudios complementarios
Estudios complementarios
Participate in I-CAN training sessions
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Intervention to enhance cognitive augmentation and neuroplasticity (I-CAN) adherence (feasibility)
Periodo de tiempo: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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Descriptive statistics will be used to examine adherence, defined as the percent completion of I-CAN cognitive training before and after infusion.
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At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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Retention
Periodo de tiempo: 12 months post-infusion, up to 14 months
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Descriptive statistics will be used to examine retention, defined as % follow-up assessments completed.
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12 months post-infusion, up to 14 months
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I-CAN satisfaction (feasibility)
Periodo de tiempo: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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Descriptive statistics will be used to examine acceptability, defined as % satisfaction on Client Satisfaction Questionnaire.
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At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Functional Assessment of Cancer Therapy-Cognition Perceived Cognitive Impairment (FACT-Cog PCI)
Periodo de tiempo: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
|
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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At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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Change in Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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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.
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At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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Change in depression
Periodo de tiempo: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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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.
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At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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Change in anxiety
Periodo de tiempo: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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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.
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At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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Change in frailty
Periodo de tiempo: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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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.
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At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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Healthcare utilization (Number of ER visits)
Periodo de tiempo: Up to 14 months
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Number of ER visits for each participant will be assessed at each time point.
Data will be collated by review of medical records.
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Up to 14 months
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Healthcare utilization (Hospital admissions/readmissions)
Periodo de tiempo: Up to 14 months
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Number of hospital admissions / readmissions for each participant will be assessed at each time point.
Data will be collated by review of medical records.
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Up to 14 months
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Healthcare utilization (Length of Hospital Stay)
Periodo de tiempo: Up to 14 months
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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.
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Up to 14 months
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Return to function
Periodo de tiempo: Up to 14 months
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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).
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Up to 14 months
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Direct and indirect costs
Periodo de tiempo: Up to 14 months
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Economic evaluation of direct medical costs of healthcare utilization and indirect costs of age-specific work ability/productivity gains/losses.
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Up to 14 months
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Income changes due to changes in work productivity
Periodo de tiempo: Up to 14 months
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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.
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Up to 14 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ashley E Rosko, MD, Ohio State University Comprehensive Cancer Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
28 de abril de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
2 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
19 de mayo de 2026
Publicado por primera vez (Actual)
27 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
19 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Neoplasias
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Enfermedades linfáticas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Linfoma No Hodgkin
- Linfoma
- Neoplasias De Células Plasmáticas
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Trastornos hemorrágicos
- Enfermedades hemic y linfáticas
- Linfoma de células B
- Mieloma múltiple
- Técnicas de investigación
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Manejo de muestras
Otros números de identificación del estudio
- OSU-25086
- NCI-2026-03016 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Colección de muestras biológicas
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