Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

19. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

90

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Ohio
      • Columbus, Ohio, Vereinigte Staaten, 43210
        • Rekrutierung
        • Ohio State University Comprehensive Cancer Center
        • Hauptermittler:
          • Ashley E. Rosko, MD
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verfahren: Sammlung von Bioproben
Entnahme von Blutproben durchführen
Andere Namen:
  • Biologische Probensammlung
  • Bioprobe gesammelt
  • Probenentnahme
Sonstiges: Umfrageverwaltung
Nebenstudien
Sonstiges: Überprüfung der elektronischen Patientenakte
Nebenstudien
Sonstiges: Cognitive Intervention
Participate in I-CAN training sessions

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intervention to enhance cognitive augmentation and neuroplasticity (I-CAN) adherence (feasibility)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Functional Assessment of Cancer Therapy-Cognition Perceived Cognitive Impairment (FACT-Cog PCI)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ohio State University Comprehensive Cancer Center

Mitarbeiter

National Institutes of Health (NIH)

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

28. April 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

31. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

2. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Mai 2026

Zuerst gepostet (Tatsächlich)

27. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Refraktäres B-Zell-Non-Hodgkin-Lymphom

Klinische Studien zur Sammlung von Bioproben

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Lithuania

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren