Actively Recruiting
Intervention to Enhance Cognitive Augmentation and Neuroplasticity (I-CAN) Program for Patients with Relapsed or Refractory Multiple Myeloma or B-cell Non-Hodgkin Lymphoma Undergoing CAR-T Therapy
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-05-27
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Ohio State University Comprehensive Cancer Center
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an online cognitive training program called Intervention to enhance Cognitive Augmentation and Neuroplasticity (I-CAN) in patients with relapsed or refractory multiple myeloma or B-cell non-Hodgkin lymphoma undergoing chimeric antigen receptor T-cell (CAR-T) therapy. The study aims to see if this training, delivered before and after CAR-T treatment, can help improve cognitive and neurological outcomes affected by cancer treatment side effects such as attention, memory, language, and executive function problems. Participants complete online I-CAN training sessions totaling about 20 hours over 8 weeks, with 2.5 hours per week before and after CAR-T therapy. The program focuses on improving brain function through speed and accuracy of processing, adaptability, generalizability, and engagement. Alongside training, blood samples are collected at various points during the study to explore molecular markers related to aging and cognition. Throughout the study, participants are assessed using cognitive tests like the Functional Assessment of Cancer Therapy-Cognition Perceived Cognitive Impairment (FACT-Cog PCI) and Montreal Cognitive Assessment (MoCA), as well as measures of anxiety, depression, frailty, and healthcare use. Follow-up visits occur at 1, 3, and 12 months after CAR-T infusion to monitor adherence, satisfaction, cognitive changes, and other health outcomes over up to 14 months.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Diagnosed with relapsed or refractory multiple myeloma or B-cell non-Hodgkin lymphoma
- Expected to receive FDA-approved CAR-T cellular treatment
- Able to read and understand English
You will not qualify if you...
- Patients expected to live less than 6 months
- Major medical disorders affecting cognition such as stroke, encephalitis, traumatic brain injury, or brain surgery
- Confirmed Alzheimer's disease or other dementia
- Previous central nervous system radiation
- Active intrathecal therapy at time of enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - 8 weeks
Participants engage in the I-CAN cognitive training program for 4 weeks before and 4 weeks after CAR-T therapy, totaling approximately 20 hours over 8 weeks.
Weekly online training sessions totaling about 2.5 hours per week
Duration - Duration of CAR-T therapy administration
Participants receive FDA-approved CAR-T cellular treatment for their hematologic malignancy.
Visits as part of routine CAR-T therapy care (visit details vary)
Duration - Up to 14 months
Participants undergo blood sample collection and assessments of cognition, frailty, anxiety, and other health measures throughout the study.
Multiple visits for blood draws and assessments at baseline, 1, 2, 3, 5, and 14 months post-infusion
Duration - 12 months
Participants are followed up at 1, 3, and 12 months after CAR-T infusion to monitor cognitive and neurological outcomes as well as healthcare utilization and return to function.
3 follow-up visits at 1, 3, and 12 months post-infusion
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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