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| ID | Type | Description | Link |
|---|---|---|---|
| HM300000218 | Other Identifier | Virginia Commonwealth University |
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| Name | Class |
|---|---|
| American Psychological Foundation | OTHER |
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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:
Participants will also be asked to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Patient | Experimental | Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training. |
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| Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Caregiver | Experimental | Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training. |
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| Brain health Education and Wellness (BE Well) - Patient | Experimental | Time-matched educational videos focused on maximizing brain health in the context of brain tumor. |
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| Brain health Education and Wellness (BE Well) - Caregiver | Experimental | Time-matched educational videos focused on maximizing brain health in the context of brain tumor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-SMART | Behavioral | Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients- Eligibility Rate | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor - Enrollment Rate | 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 |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver Inclusion Criteria
Caregiver Exclusion Criteria
-N/A
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Braun, Ph.D | Contact | 804-628-7028 | sarah.braun@vcuhealth.org | |
| Brighton Payne, BS | Contact | 804-628-6799 | brightonph@vcu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Braun, Ph.D | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23298 | United States |
There are no plans to share individual patient data "IPD" at this time.
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Parallel Assignment, Patients with primary brain tumor and their caregivers. 42 participants (24 patients and 18 caregivers)[Anticipated]
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Double (Participant, Outcomes Assessor)
| BE Well | Behavioral | Eight weekly 45- to 60-minute video lectures |
|
| Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients - Participant recommendation ratings. | 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 |
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 | 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. | 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) | 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) | 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) | 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 | 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 | 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 | 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 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |