Status:
COMPLETED
C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
American Psychological Foundation
American Cancer Society, Inc.
Conditions:
Glioma, Mixed
Mild Neurocognitive Disorder
Eligibility:
All Genders
18+ years
Brief Summary
The goal of Phase IIa Trial is to determine the feasibility and acceptability of telehealth C-SMART for patients with primary brain tumor and mild neurocognitive deficits (N=36) and their caregivers (...
Eligibility Criteria
Inclusion
- 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 ICCTF clinical trials battery and Test of Premorbid Functioning for comparison
- \>1 month post brain surgery and/or radiation therapy, if applicable
- Estimated premorbid intelligence \>75.
- Patients must be age 18+ and primarily English speaking
Exclusion
- 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; based on EAB results
- Clinically significant insomnia 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.
- To participate in the fMRI portion of this study participants cannot have any metal in their bodies. For the fMRI subset, participants cannot have metal in their body as the MRI scan could cause them harm and if female of childbearing years, they cannot be pregnant as the MRI scan may pose risk to the unborn fetus.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 23 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05984667
Start Date
September 15 2023
End Date
July 23 2025
Last Update
August 1 2025
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298