Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Multiple Myeloma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory Multiple Myeloma
Conditions
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.
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.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of blood samples
OTHERCognitive Intervention
Participate in I-CAN training sessions
OTHERElectronic Health Record Review
Ancillary studies
OTHERSurvey Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
National Institutes of Health (NIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention to enhance cognitive augmentation and neuroplasticity (I-CAN) adherence (feasibility) | 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. |
| Retention | 12 months post-infusion, up to 14 months | Descriptive statistics will be used to examine retention, defined as % follow-up assessments completed. |
| I-CAN satisfaction (feasibility) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Change in Montreal Cognitive Assessment (MoCA) | 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. |
| Change in depression | 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. |
| Change in anxiety | 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. |
| Change in frailty | 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. |
| Healthcare utilization (Number of ER visits) | 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. |
| Healthcare utilization (Hospital admissions/readmissions) | 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. |
| Healthcare utilization (Length of Hospital Stay) | 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. |
| Return to function | 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). |
| Direct and indirect costs | Up to 14 months | Economic evaluation of direct medical costs of healthcare utilization and indirect costs of age-specific work ability/productivity gains/losses. |
| Income changes due to changes in work productivity | 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. |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORAshley E Rosko, MD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed