Cognitive Strategies, Mindfulness & Rehabilitation (C-SMART) versus Brain Health Education and Wellness (BE Well) for adults with brain tumors
Phase II Randomized Controlled Trial of C-SMART Versus BE Well for Patients With Brain Tumors on Neurocognitive and Neuroimaging Outcomes
This project will test whether an 8-week individualized telehealth program combining cognitive rehabilitation and mindfulness (C-SMART) helps adults with brain tumors more than an 8-week brain health education video program (BE Well).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT07224503 on ClinicalTrials.gov |
What this trial studies
Adults with primary brain tumors who show at least one domain of cognitive impairment are assigned to one of two 8-week interventions: C-SMART, which delivers 8 weekly one-on-one telehealth sessions targeting cognitive weaknesses identified at baseline, or BE Well, which provides 8 weekly brain health education videos. Participants complete baseline and end-of-study surveys and undergo two in-person visits for MRI and standardized neurocognitive testing. The C-SMART program is manualized and combines cognitive rehabilitation techniques with mindfulness meditation training tailored to each participant's test results. Feasibility, acceptability, and preliminary signals of cognitive or functional benefit are collected to inform larger trials.
Who should consider this trial
Good fit: Adults (18+) who are patients of the Virginia Commonwealth University Neuro-Oncology clinic with a confirmed primary brain tumor, primarily English-speaking, premorbid IQ >75, at least one cognitive domain >1.5 SD below expected, and more than one month after surgery or radiation when applicable.
Not a fit: Patients with major neurocognitive impairment that prevents participation, severe aphasia, inability to provide informed consent, or inability to attend weekly telehealth appointments are unlikely to benefit from the interventions.
Why it matters
Potential benefit: If successful, C-SMART could reduce cognitive problems and improve daily functioning and coping by teaching targeted cognitive strategies alongside mindfulness skills compared with education alone.
How similar studies have performed: Related cognitive rehabilitation and mindfulness programs have shown benefits for cancer-related cognitive complaints, but combining these approaches and delivering them virtually to brain tumor patients is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Sarah Braun, Ph.D — Virginia Commonwealth University
- Study coordinator: Sarah Braun, Ph.D
- Email: sarah.braun@vcuhealth.org
- Phone: 804-628-7028
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.