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

Description

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.

Conditions

Glioma, Mixed, Mild Neurocognitive Disorder, Brain Tumor

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Study Overview

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Study Details

Study overview

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.

C-SMART for Patients With Primary Brain Tumors: A Feasibility and Acceptability Pilot of a Novel Neuropsychological Intervention

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

Condition
Glioma, Mixed
Intervention / Treatment

-

Contacts and Locations

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Virginia Commonwealth University,

Sarah E Braun, PhD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

2026-09-30