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
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Study ID
- NCT07609030
- Status
- Recruiting
Conditions
- Recurrent B-Cell Non-Hodgkin Lymphoma
- Recurrent Multiple Myeloma
- Refractory B-Cell Non-Hodgkin Lymphoma
- Refractory Multiple Myeloma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo collection of blood samples
- Cognitive Intervention — OTHERParticipate in I-CAN training sessions
- Electronic Health Record Review — OTHERAncillary studies
- Survey Administration — OTHERAncillary studies
Study Details
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.
Key Dates
- Start date
- Apr 28, 2026
- Status verified
- May 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 90 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- 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.
Primary Outcome Measure
Intervention to enhance cognitive augmentation and neuroplasticity (I-CAN) adherence (feasibility) [ Time Frame: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5) ]
Central Contacts
- The Ohio State University Comprehensive Cancer Center800-293-5066
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Ashley E. Rosko, MD (PRINCIPAL_INVESTIGATOR) |
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