C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors

Last updated: July 30, 2025
Sponsor: Virginia Commonwealth University
Overall Status: Completed

Phase

N/A

Condition

Cancer/tumors

Gliomas

Neurofibromatosis

Treatment

C-SMART

Clinical Study ID

NCT05984667
MCC-22-20126
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Confirmed primary brain tumor diagnosis by histology or neuro-oncologist review ofimaging

  2. At least one domain of neurocognitive function >1.5 SD below the average or theindividual's estimated premorbid functioning, using the expanded ICCTF clinicaltrials 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

Exclusion Criteria:

  1. Presence of major neurocognitive impairment that would prevent participation in theintervention, and/or severe aphasia, and/or inability to understand and provideinformed 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 metalin their bodies. For the fMRI subset, participants cannot have metal in their bodyas the MRI scan could cause them harm and if female of childbearing years, theycannot be pregnant as the MRI scan may pose risk to the unborn fetus.

Study Design

Total Participants: 33
Treatment Group(s): 1
Primary Treatment: C-SMART
Phase:
Study Start date:
September 15, 2023
Estimated Completion Date:
July 23, 2025

Connect with a study center

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

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