此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

C-SMART与BE Well针对脑肿瘤患者的疗效对比

2026年9月21日 更新者：Virginia Commonwealth University

针对脑肿瘤患者神经认知和神经影像学结果的C-SMART与BE Well方案二期随机对照试验

The goal of this clinical trial is to learn about the acceptability and feasibility of Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) and Brain health Education and Wellness (BE Well) in adults with brain tumors and their caregivers.

Participants will be assigned to one of the two groups:

  • Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) is a recently developed virtual intervention combining both cognitive rehabilitation with mindfulness meditation training. The manualized program consists of 8 weekly 1:1 tele intervention sessions, targeting cognitive weaknesses identified from baseline cognitive testing.
  • Brain health Education and Wellness (BE Well) intervention consists of 8 weekly videos focused on maximizing brain health in the context of brain tumor.

Participants will also be asked to:

  • participate in two in-person visits involving an MRI (if eligible for research MRIs) and neurocognitive tests
  • complete a survey the the beginning and end of the study
  • if in BE Well group, answer a few questions after watching each video

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

56

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Virginia
      • Richmond、Virginia、美国、23298
        • 招聘中
        • Virginia Commonwealth University
        • 接触：
        • 首席研究员：
          • Sarah Braun, Ph.D

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Patient Inclusion Criteria:

  • Patient of Virginia Commonwealth University Neuro-Oncology clinic
  • Confirmed primary brain tumor diagnosis by histology or neuro-oncologist review of imaging
  • At least one domain of neurocognitive function >1.5 SD below the average or the individual's estimated premorbid functioning, using the expanded International Cognition and Cancer Task Force (ICCTF) clinical trials battery and Test of Premorbid Functioning (TOPF)62 for comparison; (3) >1 month post brain surgery and/or radiation therapy, if applicable;
  • Estimated premorbid intelligence using TOPF >75.
  • Patients must be age 18+ and
  • Primarily English speaking.

Patient Exclusion Criteria:

  • Presence of major neurocognitive impairment that would prevent participation in the intervention, and/or severe aphasia, and/or inability to understand and provide informed consent
  • Referred participants who are suspected to have major neurocognitive impairment will be administered the Telephone Interview for Cognitive Status (TICS) during the pre-screening phase. Scores of <20 indicate major neurocognitive impairment and will result in exclusion from study participation;
  • Inability to attend weekly telehealth appointments
  • Clinically significant insomnia symptoms coupled with report that insomnia is more interfering than cognitive symptoms
  • < 1 month post brain surgery and/or radiation therapy
  • Unstable internet connection or an inability to work teleconferencing software. Participants will be supplied an iPad if they do not have an adequate device.
  • Exclusion criteria for the MRI portion of the study includes (6)implants, objects, or devices that are not MR safe, as the MRI scan could cause them harm.
  • Additionally, if female of childbearing years, they cannot be pregnant as the MRI scan may pose risk to the unborn fetus. Those participants who have implants, objects, or devices that are not MRI safe and/or are pregnant but are otherwise eligible will participate in all other study activities, excluding MRI.

Caregiver Inclusion Criteria

  • Must enroll with a patient (see criteria above)
  • Must be age 18+ and
  • Primarily English speaking

Caregiver Exclusion Criteria

-N/A

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Patient

Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.
行为的：C-SMART

Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing
实验性的：Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Caregiver

Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.
行为的：C-SMART

Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing
实验性的：Brain health Education and Wellness (BE Well) - Patient

Time-matched educational videos focused on maximizing brain health in the context of brain tumor.
行为的：BE Well

Eight weekly 45- to 60-minute video lectures
实验性的：Brain health Education and Wellness (BE Well) - Caregiver

Time-matched educational videos focused on maximizing brain health in the context of brain tumor.
行为的：BE Well

Eight weekly 45- to 60-minute video lectures

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients- Eligibility Rate
大体时间：From time participant indicates interest to screening completion, 4 weeks

The percentage of participants that are eligible to enroll
From time participant indicates interest to screening completion, 4 weeks
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients - Enrollment Rate
大体时间：From screening to intervention initiation, 8 weeks

The percentage of participants that enroll
From screening to intervention initiation, 8 weeks
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients -- retention rate
大体时间：From baseline to end of study, 28 weeks

The percentage of participants that complete the post-intervention data collection
From baseline to end of study, 28 weeks
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients -- intervention completion rate
大体时间：From baseline to end of intervention, 16 weeks

The percentage of participants that complete the the protocol assigned interventions
From baseline to end of intervention, 16 weeks
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients - Participant satisfaction ratings
大体时间：From baseline to post-intervention survey completion, 20 weeks

Participant ratings of satisfaction. Participants will rate the following questions on a scale from completely disagree to completely agree: C-SMART/BE Well Meets my approval; C-SMART/BE Well is appealing to the patient; "I like C-SMART/BE Well"; "I welcome C-SMART/BE Well". Additionally, participants will answer the following question on a scale from extremely dissatisfied to extremely satisfied: "When you signed up for the study, you were told that you would be randomized to either C-SMART or BE Well Videos. How satisfied are you with the group you were randomized to?"
From baseline to post-intervention survey completion, 20 weeks
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients - Participant recommendation ratings.
大体时间：From baseline to post-intervention survey completion, 20 weeks

Participant ratings of intervention recommendation Participants will answer the following question: Would "you" (the patient) recommend C-SMART/BE Well to other brain tumor patients?
From baseline to post-intervention survey completion, 20 weeks

次要结果测量

结果测量
措施说明
大体时间
Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor - Enrollment Rate
大体时间：From screening to intervention initiation, 8 weeks

The percentage of participants that enroll
From screening to intervention initiation, 8 weeks
Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor patients -- retention rate
大体时间：From baseline to end of study, 28 weeks

The percentage of participants that complete the post-intervention data collection
From baseline to end of study, 28 weeks
Assess the acceptability of the C-SMART and BE Well protocols in caregivers of brain tumor patients - Participant satisfaction ratings
大体时间：From baseline to post-intervention survey completion, 20 weeks

Participant ratings of satisfaction. Participants will rate the following questions on a scale from completely disagree to completely agree: C-SMART/BE Well Meets my approval; C-SMART/BE Well is appealing to the patient; "I like C-SMART/BE Well"; "I welcome C-SMART/BE Well". Additionally, participants will answer the following question on a scale from extremely dissatisfied to extremely satisfied: "When you signed up for the study, you were told that your loved one would be randomized to either C-SMART or BE Well Videos. How satisfied are you with the group your loved one was randomized to?"
From baseline to post-intervention survey completion, 20 weeks
Assess the acceptability of the C-SMART and BE Well protocols in caregivers of brain tumor patients - Participant recommendation ratings.
大体时间：From baseline to post-intervention survey completion, 20 weeks

Participant ratings of intervention recommendation. Participants will answer the following question: Would "you" (the caregiver) recommend C-SMART/BE Well to other caregivers?
From baseline to post-intervention survey completion, 20 weeks
Investigate effect of interventions on neurocognitive tests Hopkins Verbal Learning Test (verbal learning and memory)
大体时间：Baseline to post-intervention assessment, up to 28 weeks

Changes in neurocognitive assessment scores (pre vs post intervention) between groups based on the Hopkins Verbal Learning Test (verbal learning and memory) neurocognitive test. Participant performance on the verbal learning and memory task will consist of three learning trials and a delay. A high score on the learning trials but a very low score on the delayed recall would show that the person can learn but has difficulty retrieving previously learned information.
Baseline to post-intervention assessment, up to 28 weeks
Investigate effect of interventions on neurocognitive test Controlled Oral Word Association (verbal fluency)
大体时间：Baseline to post-intervention assessment, up to 28 weeks

Changes in neurocognitive assessment scores (pre vs post intervention) between groups based on the Controlled Oral Word Association (verbal fluency) neurocognitive test. Participant performance on the verbal fluency task will consist of generating words in 60 seconds on phonemic trials (words that start with a specific letter) and semantic trials (words that fall into a specific category). Scores are the number of correctly retrieved words. A higher raw score indicates greater verbal fluency.
Baseline to post-intervention assessment, up to 28 weeks
Investigate effect of interventions on neurocognitive test Trail Making (attention and task switching)
大体时间：Baseline to post-intervention assessment, up to 28 weeks

Changes in neurocognitive assessment scores (pre vs post intervention) between groups based on Trail Making (processing speed and task switching). Participant performance will consist of time (in seconds) to complete a processing speed and switching task in which participants are asked to draw lines in sequential order, and then switch between two overlearned sequences. A shorter time to completion would indicate greater processing speed and task switching.
Baseline to post-intervention assessment, up to 28 weeks
Investigate effect of interventions on subjective cognition
大体时间：Baseline to post-intervention assessment, up to 20 weeks

Changes in subjective cognition (pre vs post intervention) between groups based on the Neuro-Qol Short Form the National Institutes of Health (NIH) toolbox. Participants rate their experience of cognitive slips on 4 questions from "never" to "very often", and 4 questions from "no difficulty" to "cannot do". Higher scores indicate greater subjective cognition. Scores range from 8-40. Raw scores can be converted into standardized scores (T-scores) with a mean of 50 and a standard deviation (SD) of 10. Thus, a person who has a T-score of 60 is one SD above the average of the US general population.
Baseline to post-intervention assessment, up to 20 weeks
Investigate effect of interventions on fatigue
大体时间：Baseline to post-intervention assessment, up to 20 weeks

Changes in fatigue (pre vs post intervention) between groups based on the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue short form. Participants rate their experience of fatigue on 4 items from "not at all" to "very much". Higher scores indicate greater fatigue. Scores range from 4-20. Raw scores can be converted into standardized scores (T-scores) with a mean of 50 and a standard deviation (SD) of 10. Thus, a person who has a T-score of 60 is one SD above the average of the US general population.
Baseline to post-intervention assessment, up to 20 weeks
Structural brain changes
大体时间：From baseline to post-outcome assessment, 28 weeks

Change in brain volume (pre vs. post intervention) between groups based on brain imaging (MRI) data. The volume of lateral ventricle in the hemisphere opposite to the tumor will be measured, using 3D Slicer (https://www.slicer.org) to calculate the ventricular volume at each time point which will serve as an index of diffuse cerebral volume loss.
From baseline to post-outcome assessment, 28 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Virginia Commonwealth University

合作者

American Psychological Foundation

调查人员

  • 首席研究员：Sarah Braun, Ph.D、Virginia Commonwealth University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月1日

初级完成 (估计的)

2027年10月31日

研究完成 (估计的)

2027年10月31日

研究注册日期

首次提交

2025年10月31日

首先提交符合 QC 标准的

2025年10月31日

首次发布 (实际的)

2025年11月4日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月21日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • MCC-25-22557
  • HM300000218 (其他标识符：Virginia Commonwealth University)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

There are no plans to share individual patient data "IPD" at this time.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅