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
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Biospecimen Collection, Cognitive Intervention, Electronic Health Record Review, Survey Administration.
- Кому может быть актуально
- Состояния в реестре: Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Multiple Myeloma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory Multiple Myeloma. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Intervention to Enhance Cognitive Augmentation and Neuroplasticity (I-CAN)
Обзор
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.
Подробное описание
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.
Вмешательства
- Процедура Biospecimen Collection
Undergo collection of blood samples - Другое Cognitive Intervention
Participate in I-CAN training sessions - Другое Electronic Health Record Review
Ancillary studies - Другое Survey Administration
Ancillary studies
Первичные конечные точки
- Intervention to enhance cognitive augmentation and neuroplasticity (I-CAN) adherence (feasibility) [Срок оценки: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)]
- Retention [Срок оценки: 12 months post-infusion, up to 14 months]
- I-CAN satisfaction (feasibility) [Срок оценки: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)]
Вторичные конечные точки (11)
- Change in Functional Assessment of Cancer Therapy-Cognition Perceived Cognitive Impairment (FACT-Cog PCI) [Срок оценки: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)]
- Change in Montreal Cognitive Assessment (MoCA) [Срок оценки: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)]
- Change in depression [Срок оценки: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)]
- Change in anxiety [Срок оценки: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)]
- Change in frailty [Срок оценки: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)]
- Healthcare utilization (Number of ER visits) [Срок оценки: Up to 14 months]
- Healthcare utilization (Hospital admissions/readmissions) [Срок оценки: Up to 14 months]
- Healthcare utilization (Length of Hospital Stay) [Срок оценки: Up to 14 months]
- Return to function [Срок оценки: Up to 14 months]
- Direct and indirect costs [Срок оценки: Up to 14 months]
- Income changes due to changes in work productivity [Срок оценки: Up to 14 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- Ohio State University Comprehensive Cancer Center — Columbus
Идентификаторы
NCT: NCT07609030 · OSU-25086 · NCI-2026-03016