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C-SMART vs BE Well for Patients With Brain Tumors

RECRUITINGN/ASponsored by Virginia Commonwealth University
Actively Recruiting
PhaseN/A
SponsorVirginia Commonwealth University
Started2025-12-01
Est. completion2027-10-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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. 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 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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Brain TumorCancer

Locations1 site

Virginia Commonwealth University
Richmond, Virginia, 23298
Sarah Braun, Ph.D804-628-7028sarah.braun@vcuhealth.org

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