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NCT Number: NCT07609030

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

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.

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Key information

Conditions

Recurrent B-Cell Non-Hodgkin Lymphoma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Recurrent Multiple Myeloma Refractory B-Cell Non-Hodgkin Lymphoma Refractory Multiple Myeloma Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Ashley E. Rosko, MD

CONTACT

[email protected]

614-688-7397

Ashley E. Rosko, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood samples

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Cognitive Intervention

Other

Participate in I-CAN training sessions

Electronic Health Record Review

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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.

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

The Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Intervention to Enhance Cognitive Augmentation and Neuroplasticity (I-CAN)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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