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NCT05984667 | RECRUITING | Glioma, Mixed

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

Virginia Commonwealth University

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 (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.

Condition or disease

Glioma, Mixed

Mild Neurocognitive Disorder

Brain Tumor

Intervention/treatment

C-SMART

Study Type : OBSERVATIONAL
Estimated Enrollment : 72 participants
Official Title : C-SMART for Patients With Primary Brain Tumors: A Feasibility and Acceptability Pilot of a Novel Neuropsychological Intervention
Actual Study Start Date : 2023-09-15
Estimated Primary Completion Date : 2026-09-30
Estimated Study Completion Date : 2026-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors

Location Details

NCT05984667

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Locations

RECRUITING

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23298