Glioma, MixedC-SMARTNCT05984667
C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors
An observational study of Glioma, Mixed and Mild Neurocognitive Disorder, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The goal of Phase Ib Trial is to determine the feasibility and acceptability of telehealth C-SMART for patients with primary brain tumor and mild neurocognitive deficits (N=18) and their caregivers (N=14) A subset (n=3) of participants will undergo rs-fMRI both pre- and post-C-SMART to test feasibility of advanced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Mixed, Mild Neurocognitive Disorder, Brain Tumor
- What is being tested?
- C-SMART
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2023to 23 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with primary brain tumor and mild neurocognitive disorder (mNCD) and informal caregivers
Patient Inclusion Criteria:
- 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 ICCTF clinical trials battery and Test of Premorbid Functioning for comparison
- >1 month post brain surgery and/or radiation therapy, if applicable
- Estimated premorbid intelligence >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
- Inability to attend weekly telehealth appointments; based on EAB results
- Clinically significant insomnia 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.
- To participate in the fMRI portion of this study participants cannot have any metal in their bodies. For the fMRI subset, participants cannot have metal in their body as the MRI scan could cause them harm and if female of childbearing years, they cannot be pregnant as the MRI scan may pose risk to the unborn fetus.
Caregiver Inclusion Criteria
- Must be an adult caregiver of an enrolled patient (see criteria above)
- Primarily English speaking
Caregiver Exclusion Criteria
- Paid caregiver (e.g. home health aide)
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: C-SMART for Patients With Primary Brain Tumors: A Feasibility and Acceptability Pilot of a Novel Neuropsychological Intervention
The goal of Phase Ib Trial is to determine the feasibility and acceptability of telehealth C-SMART for patients with primary brain tumor and mild neurocognitive deficits (N=18) and their caregivers (N=14) A subset (n=3) of participants will undergo rs-fMRI both pre- and post-C-SMART to test feasibility of advanced functional imaging in this population.
- Conditions
- Glioma, Mixed, Mild Neurocognitive Disorder, Brain Tumor
- Being tested
- C-SMART
- Keywords
- Mindfulness, Cognitive rehabilitation, rs-fMRI
- Medical subject headings
- Glioma, Neurocognitive Disorders, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-SMARTBehavioural
The C-SMART intervention includes approximately 8 individual therapy sessions, each approximately 60 minutes in length, delivered weekly. C-SMART intervention components include cognitive rehabilitation and mindfulness training.
| Study group | Role | What they receive |
|---|---|---|
| Patient | C-SMART intervention will be provided via telehealth. Participants will complete in-person neurocognitive testing (baseline, post-intervention) as well as surveys (baseline, post-session, post-intervention) via secure email link. Exit interviews will be conducted by Zoom. Receives: Behavioral: C-SMART | |
| Caregiver | Informal caregiver that may enroll with the patient (not required) Receives: Behavioral: C-SMART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine feasibility of C-SMART recruitment
As evidenced by rates of participant screening, eligibility, and consent
Measured: 10 months
Determine feasibility of C-SMART - Data collection procedures
As evidenced by the number of participants that complete the neurocognitive assessments pre- and post-intervention
Measured: 10 months
Determine feasibility of C-SMART - Retention Rate
As evidenced by the number of patients that complete post-intervention measures
Measured: 11 months
Determine acceptability of C-SMART intervention - Satisfaction
After each intervention session, participants will be sent a link for a brief post-session satisfaction survey via secure email link. In this survey, participants will rate 1) topic applicability; 2) perceived benefit of session; 3) comfort with interventionist(s); 4) overall satisfaction and 5) likelihood of recommending the program to others. Responses are ranked on a Likert-type scale from 1 being "Not at all" to 5 being "A great deal". Higher scores indicate greater satisfaction with the intervention session.
Measured: 10 months
Determine acceptability of C-SMART intervention - Satisfaction - Recommendation
As evidenced by the number of patients that would recommend the intervention to others
Measured: 10 months
Optimization of C-SMART research procedures
The number of participants that complete exit interviews will be audio recorded and transcribed verbatim. The PI and a second independent coder will separately review each transcript to identify common themes and develop a coding framework of free responses. All results will be reviewed for agreement and comparison to the raw data, and discrepancies will be resolved through discussion with the PI until reliability is reached (Kappa>.80)
Measured: 8 months
Determine preliminary feasibility of longitudinal rs-fMRI procedures for a subset of patients
Completion rate of neuroimaging at post-intervention
Measured: 10 months
Secondary outcomes (1)
Determine feasibility of C-SMART research procedures - Patient reported outcome completion
Feasibility of research procedures will be assessed by the number of participants that complete the baseline survey, post-session survey, and the post-intervention survey.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start15 Sep 2023
- Primary completion23 Jul 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma, MixedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Foundation, American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Sarah E Braun, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984667
- Sponsor's protocol ID
- MCC-22-20126
- Acronym
- C-SMART
- Status last verified
- Jul 2025
- First submitted
- 1 Aug 2023
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) to other researchers at this time.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-SMART for Patients With Primary Brain Tumors: A Feasibility and Acceptability Pilot of a Novel Neuropsychological Intervention
- ClinicalTrials.gov ID
- NCT05984667
- Acronym / sponsor ID
- C-SMART / MCC-22-20126
- Conditions
- Glioma, Mixed, Mild Neurocognitive Disorder, Brain Tumor
- Keywords
- Mindfulness, Cognitive rehabilitation, rs-fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- American Psychological Foundation, American Cancer Society, Inc.
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 9 Aug 2023 (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 Phase Ib Trial is to determine the feasibility and acceptability of telehealth C-SMART for patients with primary brain tumor and mild neurocognitive deficits (N=18) and their caregivers (N=14) A subset (n=3) of participants will undergo rs-fMRI both pre- and post-C-SMART to test feasibility of advanced functional imaging in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Behavioral: C-SMARTC-SMART intervention will be provided via telehealth. Participants will complete in-person neurocognitive testing (baseline, post-intervention) as well as surveys (baseline, post-session, post-intervention) via secure email link. Exit interviews will be conducted by Zoom. |
| Caregiver | – | Behavioral: C-SMARTInformal caregiver that may enroll with the patient (not required) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary brain tumor and mild neurocognitive disorder (mNCD) and informal caregivers
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-SMARTThe C-SMART intervention includes approximately 8 individual therapy sessions, each approximately 60 minutes in length, delivered weekly. C-SMART intervention components include cognitive rehabilitation and mindfulness training. | Behavioural | Caregiver, Patient |
Primary outcome
Determine feasibility of C-SMART recruitment
Time frame: 10 months
As evidenced by rates of participant screening, eligibility, and consent
Determine feasibility of C-SMART - Data collection procedures
Time frame: 10 months
As evidenced by the number of participants that complete the neurocognitive assessments pre- and post-intervention
Determine feasibility of C-SMART - Retention Rate
Time frame: 11 months
As evidenced by the number of patients that complete post-intervention measures
Determine acceptability of C-SMART intervention - Satisfaction
Time frame: 10 months
After each intervention session, participants will be sent a link for a brief post-session satisfaction survey via secure email link. In this survey, participants will rate 1) topic applicability; 2) perceived benefit of session; 3) comfort with interventionist(s); 4) overall satisfaction and 5) likelihood of recommending the program to others. Responses are ranked on a Likert-type scale from 1 being "Not at all" to 5 being "A great deal". Higher scores indicate greater satisfaction with the intervention session.
Determine acceptability of C-SMART intervention - Satisfaction - Recommendation
Time frame: 10 months
As evidenced by the number of patients that would recommend the intervention to others
Optimization of C-SMART research procedures
Time frame: 8 months
The number of participants that complete exit interviews will be audio recorded and transcribed verbatim. The PI and a second independent coder will separately review each transcript to identify common themes and develop a coding framework of free responses. All results will be reviewed for agreement and comparison to the raw data, and discrepancies will be resolved through discussion with the PI until reliability is reached (Kappa>.80)
Determine preliminary feasibility of longitudinal rs-fMRI procedures for a subset of patients
Time frame: 10 months
Completion rate of neuroimaging at post-intervention
1 secondary outcome
Determine feasibility of C-SMART research procedures - Patient reported outcome completion
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) to other researchers 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. This study is not recruiting at the moment.
Sarah E Braun, PhD 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?
An observational study of Glioma, Mixed and Mild Neurocognitive Disorder, 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: finished, as of the sponsor's last update on 20 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine feasibility of C-SMART recruitment (time frame: 10 months). The study lists 7 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 20 Feb 2026.