RECRUITING Not applicable ClinicalTrials.gov

C-SMART vs BE Well for Patients With Brain Tumors

Sponsor: Virginia Commonwealth University • ClinicalTrials.gov ID: NCT07224503

Registry updated: 2026-09-25

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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. 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

Interventions

C-SMART (Behavioral)
Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing
BE Well (Behavioral)
Eight weekly 45- to 60-minute video lectures

Eligibility 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 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

Conditions

Brain Tumor

Locations

Virginia Commonwealth University — Richmond, Virginia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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