Brain TumorNCT07224503
C-SMART vs BE Well for Patients With Brain Tumors
A study testing C-SMART and BE Well in people with Brain Tumor, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- C-SMART and BE Well
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Sarah Braun, Ph.D, 804-628-7028, sarah.braun@vcuhealth.org
Sarah Braun, Ph.D
About this study
Official title: Phase II Randomized Controlled Trial of C-SMART Versus BE Well for Patients With Brain Tumors on Neurocognitive and Neuroimaging Outcomes
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:
Read more
- 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
- Conditions
- Brain Tumor
- Being tested
- C-SMART, BE Well
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-SMARTBehavioural
Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing
BE WellBehavioural
Eight weekly 45- to 60-minute video lectures
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Patient | Experimental | Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training. Receives: Behavioral: C-SMART |
| Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Caregiver | Experimental | Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training. Receives: Behavioral: C-SMART |
| Brain health Education and Wellness (BE Well) - Patient | Experimental | Time-matched educational videos focused on maximizing brain health in the context of brain tumor. Receives: Behavioral: BE Well |
| Brain health Education and Wellness (BE Well) - Caregiver | Experimental | Time-matched educational videos focused on maximizing brain health in the context of brain tumor. Receives: Behavioral: BE Well |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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?"
Measured: 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.
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?
Measured: From baseline to post-intervention survey completion, 20 weeks
Secondary outcomes (10)
Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor - Enrollment Rate
The percentage of participants that enroll
Measured: 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
The percentage of participants that complete the post-intervention data collection
Measured: 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?"
Measured: 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?
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to post-outcome assessment, 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start1 Dec 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment, Patients with primary brain tumor and their caregivers. 56 participants (32 patients and 24 caregivers)\[Anticipated\]
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Foundation
- Responsible party
- Sponsor
- Investigators
- Sarah Braun, Ph.D, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224503
- Sponsor's protocol ID
- MCC-25-22557
- Other IDs
- HM300000218
- Status last verified
- Sep 2026
- First submitted
- 31 Oct 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual patient data "IPD" at this time.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Controlled Trial of C-SMART Versus BE Well for Patients With Brain Tumors on Neurocognitive and Neuroimaging Outcomes
- ClinicalTrials.gov ID
- NCT07224503
- Acronym / sponsor ID
- MCC-25-22557
- Conditions
- Brain Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- American Psychological Foundation
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 4 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel Assignment, Patients with primary brain tumor and their caregivers. 56 participants (32 patients and 24 caregivers)[Anticipated]
| Arm | Type | Receives |
|---|---|---|
| Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Patient | Experimental | Behavioral: C-SMARTModular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training. |
| Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Caregiver | Experimental | Behavioral: C-SMARTModular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training. |
| Brain health Education and Wellness (BE Well) - Patient | Experimental | Behavioral: BE WellTime-matched educational videos focused on maximizing brain health in the context of brain tumor. |
| Brain health Education and Wellness (BE Well) - Caregiver | Experimental | Behavioral: BE WellTime-matched educational videos focused on maximizing brain health in the context of brain tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-SMARTEight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing | Behavioural | Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Caregiver, Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Patient |
| BE WellEight weekly 45- to 60-minute video lectures | Behavioural | Brain health Education and Wellness (BE Well) - Caregiver, Brain health Education and Wellness (BE Well) - Patient |
Primary outcome
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients- Eligibility Rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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?
10 secondary outcomes
Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor - Enrollment Rate
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: From baseline to post-intervention survey completion, 20 weeks
Investigate effect of interventions on neurocognitive tests Hopkins Verbal Learning Test (verbal learning and memory)
Time frame: Baseline to post-intervention assessment, up to 28 weeks
Investigate effect of interventions on neurocognitive test Controlled Oral Word Association (verbal fluency)
Time frame: Baseline to post-intervention assessment, up to 28 weeks
Investigate effect of interventions on neurocognitive test Trail Making (attention and task switching)
Time frame: Baseline to post-intervention assessment, up to 28 weeks
Investigate effect of interventions on subjective cognition
Time frame: Baseline to post-intervention assessment, up to 20 weeks
Investigate effect of interventions on fatigue
Time frame: Baseline to post-intervention assessment, up to 20 weeks
Structural brain changes
Time frame: From baseline to post-outcome assessment, 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. There are no plans to share individual patient data "IPD" at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Braun, Ph.D principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-SMART and BE Well in people with Brain Tumor, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Braun, Ph.D (804-628-7028, sarah.braun@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients- Eligibility Rate (time frame: From time participant indicates interest to screening completion, 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.