90 Participants NeededMy employer runs this trial

Cognitive Training for Multiple Myeloma

TO
Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether an online program can improve thinking and memory in people with specific types of cancer. It targets individuals with multiple myeloma or B-cell non-Hodgkin lymphoma that have recurred or are unresponsive to treatment. The program, called I-CAN (Intervention to enhance Cognitive Augmentation and Neuroplasticity), serves as a brain exercise to help patients manage the mental side effects of their cancer treatment. Participants should be comfortable reading English and plan to receive CAR-T therapy. As an unphased trial, this study provides patients the chance to contribute to innovative research that could enhance cognitive health during cancer treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the I-CAN cognitive training intervention is safe?

Research has shown that cognitive training programs like I-CAN are generally safe. Studies have found that these programs can enhance brain function without harmful side effects. They help the brain form new connections, boosting memory, attention, and other mental skills.

While specific safety details about I-CAN are not provided, similar programs have been well-received by participants, with few, if any, negative effects reported. Participants in these programs usually experience improvements in thinking skills with minimal risk.

For those considering joining a trial with I-CAN, current evidence suggests it is a safe way to potentially enhance brain abilities, especially during challenging treatments like CAR-T therapy.12345

Why are researchers excited about this trial?

Unlike the standard treatments for multiple myeloma, which typically involve chemotherapy, stem cell transplants, or CAR-T therapy, I-CAN focuses on enhancing cognitive function through neuroplasticity. This approach is unique because it utilizes online cognitive training sessions to support brain health, potentially improving patients' mental sharpness before and after CAR-T therapy. Researchers are excited about I-CAN because it offers a non-invasive way to address cognitive challenges associated with multiple myeloma, providing a holistic boost to patients' overall treatment experience.

What evidence suggests that the I-CAN cognitive training is effective for improving cognitive outcomes in relapsed or refractory multiple myeloma or B-cell non-Hodgkin lymphoma?

Research has shown that programs like I-CAN can improve brain function, particularly in attention and memory. In this trial, participants will engage in the I-CAN program, which aims to strengthen brain connections and enhance thinking skills by focusing on processing speed and accuracy. Studies indicate that such programs can significantly boost cognitive abilities and slow mental decline. Specifically, the I-CAN program has noticeably improved attention and slowed cognitive decline, as measured by tests like the Montreal Cognitive Assessment. Overall, this type of cognitive training appears promising in helping patients manage mental side effects from treatments like CAR-T therapy.16789

Who Is on the Research Team?

AE

Ashley E Rosko, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with multiple myeloma or B-cell non-Hodgkin lymphoma that has come back or not responded to treatment, and who are about to receive CAR T-cell therapy. Participants should be able to use online tools and complete cognitive training activities.

Inclusion Criteria

English literacy
I am 18 years old or older.
I am expected to receive an FDA-approved CAR-T cell therapy.
See 1 more

Exclusion Criteria

Patients expected to live less than 6 months
Patients with major medical disorder known to affect cognition, such as stroke, encephalitis, traumatic brain injury, brain surgery
I am currently receiving medication injected into my spinal fluid.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Cognitive Training

Participants engage in online I-CAN cognitive training sessions for 4 weeks before CAR-T therapy

4 weeks
Online sessions, approximately 2.5 hours per week

CAR-T Therapy

Participants receive chimeric antigen receptor T-cell therapy

1 week
In-person hospital stay for infusion

Post-Treatment Cognitive Training

Participants continue online I-CAN cognitive training sessions for 4 weeks after CAR-T therapy

4 weeks
Online sessions, approximately 2.5 hours per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cognitive assessments and healthcare utilization

12 months
Follow-up visits at 1, 3, and 12 months post-infusion

What Are the Treatments Tested in This Trial?

Interventions

  • I-CAN (Intervention to enhance Cognitive Augmentation and Neuroplasticity)

Trial Overview

The study tests an online cognitive training program (I-CAN) given before and after CAR T-cell therapy, aiming to improve thinking skills in patients. It also includes surveys, biospecimen collection, and review of medical records.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Supportive care (I-CAN)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Citations

A Cognitive Training Intervention for Improving Cognitive and ...

The I-CAN intervention, when delivered before and after therapy, may help reduce the cognitive side effects of treatment in patients with ...

Evaluating the Effectiveness of Cognitive Interventions for ...

Extensive research indicates that cognitive interventions can lead to a general improvement in cognitive functioning throughout the lifespan.

The Prevalence of Treatment-Related Cognitive Changes ...

Cognitive decline is “prevalent” in patients with multiple myeloma during the first 6 months of treatment, but not during the “maintenance phase” of treatment ...

A Study Using The Montreal Cognitive Assessment

The intervention demonstrated a significant improvement in attention as measured by MoCA and a slower progression of cognitive decline as ...

Cilta-cel Safety Enhancement: Modifiable Risk Factors for Delayed Neurotoxicity and Non-Relapse Mortality

This large real-world cohort study of 761 patients establishes non-response to bridging therapy and peak ALC ≥3000/μL as critical, potentially ...

Augmenting cognitive training in older adults (The ACT Study)

Cognitive training holds promise for reducing the adverse effects of cognitive aging, enhancing neuroplasticity, cognitive efficiency, functional capacity, and ...

Neuroplasticity-Based Cognitive Remediation for ...

Studies suggest that while up to up to 75% exhibit cognitive decline during treatment, many patients will return to their pre-chemo level of functioning 1 year ...