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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

2026년 5월 19일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

90

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • Ohio
      • Columbus, Ohio, 미국, 43210
        • 모병
        • Ohio State University Comprehensive Cancer Center
        • 수석 연구원:
          • Ashley E. Rosko, MD
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
절차: 생물 표본 수집
혈액 샘플 채취
다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
다른: 설문조사 관리
보조 연구
다른: 전자 건강 기록 검토
보조 연구
다른: Cognitive Intervention
Participate in I-CAN training sessions

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Intervention to enhance cognitive augmentation and neuroplasticity (I-CAN) adherence (feasibility)
기간: 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
기간: 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)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Functional Assessment of Cancer Therapy-Cognition Perceived Cognitive Impairment (FACT-Cog PCI)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ohio State University Comprehensive Cancer Center

협력자

National Institutes of Health (NIH)

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 28일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2027년 12월 31일

연구 등록 날짜

최초 제출

2026년 5월 2일

QC 기준을 충족하는 최초 제출

2026년 5월 19일

처음 게시됨 (실제)

2026년 5월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 19일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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정황

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약물 개입

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위치

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