NCT07224503 · Virginia Commonwealth University
C-SMART vs BE Well for Patients With Brain Tumors
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
C-SMART
Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing
BEHAVIORAL
BE Well
Eight weekly 45- to 60-minute video lectures
Primary outcome measures
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?
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 \>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
- 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 -N/A
Where
- Richmond, Virginia
Collaborators
American Psychological Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 25, 2026 · Source of record for eligibility and locations