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Phase II Randomized Controlled Trial of C-SMART Versus BE Well for Patients With Brain Tumors on Neurocognitive and Neuroimaging Outcomes

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Must enroll with a patient (see criteria above)

• Must be age 18+ and

• Primarily English speaking

Locations
United States
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Sarah Braun, Ph.D
sarah.braun@vcuhealth.org
804-628-7028
Backup
Brighton Payne, BS
brightonph@vcu.edu
804-628-6799
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 42
Treatments
Experimental: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Patient
Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.
Experimental: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Caregiver
Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.
Experimental: Brain health Education and Wellness (BE Well) - Patient
Time-matched educational videos focused on maximizing brain health in the context of brain tumor.
Experimental: Brain health Education and Wellness (BE Well) - Caregiver
Time-matched educational videos focused on maximizing brain health in the context of brain tumor.
Related Therapeutic Areas
Sponsors
Collaborators: American Psychological Foundation
Leads: Virginia Commonwealth University

This content was sourced from clinicaltrials.gov