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
Intervention to Enhance Cognitive Augmentation and Neuroplasticity (I-CAN)
2 other identifiers
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2026
CompletedFirst Submitted
Initial submission to the registry
May 2, 2026
CompletedFirst Posted
Study publicly available on registry
May 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 27, 2026
May 1, 2026
1.7 years
May 2, 2026
May 19, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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)
Secondary Outcomes (11)
Change in Functional Assessment of Cancer Therapy-Cognition Perceived Cognitive Impairment (FACT-Cog PCI)
At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
Change in Montreal Cognitive Assessment (MoCA)
At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
Change in depression
At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
Change in anxiety
At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
Change in frailty
At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
- +6 more secondary outcomes
Study Arms (1)
Supportive care (I-CAN)
EXPERIMENTALPatients 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.
Interventions
Undergo collection of blood samples
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashley E Rosko, MD
Ohio State University Comprehensive Cancer Center
Central Study Contacts
The Ohio State University Comprehensive Cancer Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 2, 2026
First Posted
May 27, 2026
Study Start
April 28, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
May 27, 2026
Record last verified: 2026-05