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
- 56
- 试验地点
- 1
- 主要终点
- Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients- Eligibility 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 (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 Functioning (TOPF)62 for comparison; (3) >1 month post brain surgery and/or radiation therapy, if applicable;
- •Estimated premorbid intelligence using TOPF >
- •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
- •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
研究组 & 干预措施
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)
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)
结局指标
主要结局
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?
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?
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)
- 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)
- 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)