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Trial Title:
C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors
NCT ID:
NCT05984667
Condition:
Glioma, Mixed
Mild Neurocognitive Disorder
Brain Tumor
Conditions: Official terms:
Brain Neoplasms
Glioma
Neurocognitive Disorders
Conditions: Keywords:
Mindfulness
Cognitive rehabilitation
rs-fMRI
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
C-SMART
Description:
The C-SMART intervention includes approximately 8 individual therapy sessions, each
approximately 60 minutes in length, delivered weekly. C-SMART intervention components
include cognitive rehabilitation and mindfulness training.
Arm group label:
C-SMART
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 (N=36) A subset (n=10) of participants will undergo rs-fMRI
both pre- and post-C-SMART to test feasibility of advanced functional imaging in this
population.
Criteria for eligibility:
Study pop:
Patients with primary brain tumor and mild neurocognitive disorder (mNCD)
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Confirmed primary brain tumor diagnosis by histology or neuro-oncologist review of
imaging
2. 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
3. >1 month post brain surgery and/or radiation therapy, if applicable
4. Estimated premorbid intelligence >75.
5. Patients must be age 18+ and primarily English speaking
Exclusion Criteria:
1. 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
2. Inability to attend weekly telehealth appointments; based on EAB results
3. Clinically significant insomnia symptoms
4. < 1 month post brain surgery and/or radiation therapy
5. Unstable internet connection or an inability to work teleconferencing software.
Participants will be supplied an iPad if they do not have an adequate device.
6. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Virginia Commonwealth University
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sarah Braun, Ph.D
Phone:
804-628-7028
Email:
sarah.braun@vcuhealth.org
Contact backup:
Last name:
Giuliana Zarrella
Phone:
8046254910
Email:
giuliana.zarrella@vcuhealth.org
Start date:
September 15, 2023
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Virginia Commonwealth University
Agency class:
Other
Collaborator:
Agency:
American Psychological Foundation
Agency class:
Other
Collaborator:
Agency:
American Cancer Society, Inc.
Agency class:
Other
Source:
Virginia Commonwealth University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05984667
