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NCT07224503
C-SMART vs BE Well for Patients With Brain Tumors
Conditions: Brain Tumor
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 56
Sponsor: Virginia Commonwealth University
Location: Virginia Commonwealth University Richmond Virginia
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 (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
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 \
Source: ClinicalTrials.gov (NCT07224503). StuddyBuddy aggregates publicly available trial information.