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

May 19, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Ashley E. Rosko, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Survey Administration
Ancillary studies
Other: Electronic Health Record Review
Ancillary studies
Other: Cognitive Intervention
Participate in I-CAN training sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
Time Frame: 12 months post-infusion, up to 14 months
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)
Time Frame: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Assessment of Cancer Therapy-Cognition Perceived Cognitive Impairment (FACT-Cog PCI)
Time Frame: 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.
At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
Change in Montreal Cognitive Assessment (MoCA)
Time Frame: 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 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.
At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
Change in depression
Time Frame: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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.
At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
Change in anxiety
Time Frame: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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.
At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
Change in frailty
Time Frame: At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
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.
At 1 month (T1), 2 months (T2), 3 months (T3), 5 months (T4) and 14 months (T5)
Healthcare utilization (Number of ER visits)
Time Frame: Up to 14 months
Number of ER visits for each participant will be assessed at each time point. Data will be collated by review of medical records.
Up to 14 months
Healthcare utilization (Hospital admissions/readmissions)
Time Frame: Up to 14 months
Number of hospital admissions / readmissions for each participant will be assessed at each time point. Data will be collated by review of medical records.
Up to 14 months
Healthcare utilization (Length of Hospital Stay)
Time Frame: Up to 14 months
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.
Up to 14 months
Return to function
Time Frame: Up to 14 months
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).
Up to 14 months
Direct and indirect costs
Time Frame: Up to 14 months
Economic evaluation of direct medical costs of healthcare utilization and indirect costs of age-specific work ability/productivity gains/losses.
Up to 14 months
Income changes due to changes in work productivity
Time Frame: Up to 14 months
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.
Up to 14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Ashley E Rosko, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 2, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-25086
  • NCI-2026-03016 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Refractory B-Cell Non-Hodgkin Lymphoma

Clinical Trials on Biospecimen Collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe