Phase II Randomized Controlled Trial of C-SMART Versus BE Well for Patients With Brain Tumors on Neurocognitive and Neuroimaging Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients and caregivers- Enrollment Rate
研究概览
简要总结
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 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 Functioning62 for comparison; (3) >1 month post brain surgery and/or radiation therapy, if applicable;
- •Estimated premorbid intelligence >
- •Patients must be age 18+ and
- •Primarily English speaking.
排除标准
- •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
- •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.
- •Participants cannot have metal in their body as the MRI scan could cause them harm
- •If female of childbearing years, they cannot be pregnant as the MRI scan may pose risk to the unborn fetus
- •Caregiver Inclusion Criteria
- •Must enroll with a patient (see criteria above)
- •Must be age 18+ and
- •Primarily English speaking
- •Caregiver Exclusion Criteria
研究组 & 干预措施
Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Patient
Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.
干预措施: C-SMART (Behavioral)
Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Caregiver
Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.
干预措施: C-SMART (Behavioral)
Brain health Education and Wellness (BE Well) - Patient
Time-matched educational videos focused on maximizing brain health in the context of brain tumor.
干预措施: BE Well (Behavioral)
Brain health Education and Wellness (BE Well) - Caregiver
Time-matched educational videos focused on maximizing brain health in the context of brain tumor.
干预措施: BE Well (Behavioral)
结局指标
主要结局
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients and caregivers- Enrollment Rate
时间窗: From screening to intervention initiation, 8 weeks
The percentage of participants that enroll
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients and caregivers -- intervention completion rate
时间窗: From baseline to end of intervention, 16 weeks
The percentage of participants that complete the the protocol assigned interventions
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients and caregivers- Participant satisfaction ratings
时间窗: 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?"
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients and caregivers- Participant recommendation ratings.
时间窗: 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?
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients- Eligibility Rate
时间窗: From time participant indicates interest to screening completion, 4 weeks
The percentage of participants that are eligible to enroll
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients - Enrollment Rate
时间窗: From screening to intervention initiation, 8 weeks
The percentage of participants that enroll
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients -- retention rate
时间窗: From baseline to end of study, 28 weeks
The percentage of participants that complete the post-intervention data collection
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients -- intervention completion rate
时间窗: From baseline to end of intervention, 16 weeks
The percentage of participants that complete the the protocol assigned interventions
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients - Participant satisfaction ratings
时间窗: 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?"
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients - Participant recommendation ratings.
时间窗: 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?
次要结局
- Investigate effect of interventions on neurocognitive tests Hopkins Verbal Learning Test (verbal learning and memory)(Baseline to post-intervention assessment, up to 28 weeks)
- Investigate effect of interventions on neurocognitive test Controlled Oral Word Association (verbal fluency)(Baseline to post-intervention assessment, up to 28 weeks)
- Investigate effect of interventions on neurocognitive test Trail Making (attention and task switching)(Baseline to post-intervention assessment, up to 28 weeks)
- Investigate effect of interventions on subjective cognition(Baseline to post-intervention assessment, up to 20 weeks)
- Investigate effect of interventions on fatigue(Baseline to post-intervention assessment, up to 20 weeks)
- Structural brain changes(From baseline to post-outcome assessment, 28 weeks)
- Structural brain changes(From baseline to post-outcome assessment, 28 weeks)
- Investigate effect of interventions on fatigue(Baseline to post-intervention assessment, up to 20 weeks)
- Investigate effect of interventions on neurocognitive tests Hopkins Verbal Learning Test (verbal learning and memory)(Baseline to post-intervention assessment, up to 28 weeks)
- Investigate effect of interventions on neurocognitive test Controlled Oral Word Association (verbal fluency)(Baseline to post-intervention assessment, up to 28 weeks)
- Investigate effect of interventions on neurocognitive test Trail Making (attention and task switching)(Baseline to post-intervention assessment, up to 28 weeks)
- Investigate effect of interventions on neurocognitive test(Baseline to post-intervention assessment, up to 28 weeks)
- Investigate effect of interventions on neurocognitive test WAIS-IV Digit Span Tests (auditory working memory)(Baseline to post-intervention assessment, up to 28 weeks)
- Investigate effect of interventions on neurocognitive test Neuropsychological Assessment Battery Naming Test (naming abilities)(Baseline to post-intervention assessment, up to 28 weeks)
- Investigate effect of interventions on neurocognitive test Delis-Kaplan Executive Function System Color-Word Inference Test (inhibition and switching)(Baseline to post-intervention assessment, up to 28 weeks)
- Investigate effect of interventions on subjective cognition(Baseline to post-intervention assessment, up to 20 weeks)
- Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor - Enrollment Rate(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(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(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.(From baseline to post-intervention survey completion, 20 weeks)