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

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Mild Neurocognitive Disorder; Brain Tumor; Glioma, Mixed

Treatments: Behavioral: C-SMART

Study type: Observational

Funder types: Other

Identifiers

NCT05984667

MCC-22-20126

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

72 participants in 1 patient group

C-SMART

Description:

C-SMART intervention will be provided via telehealth. Participants will complete in-person neurocognitive testing (baseline, post-intervention) as well as surveys (baseline, post-session, post-intervention) via secure email link. Exit interviews will be conducted by Zoom.

Treatment:

Behavioral: C-SMART