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

NCT ID: NCT05984667

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2025-07-23

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.

Conditions

Glioma, Mixed; Mild Neurocognitive Disorder; Brain Tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

C-SMART

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.

C-SMART

Intervention Type: BEHAVIORAL

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.

Interventions

C-SMART

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Psychological Foundation

OTHER

Sponsor Role: collaborator

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah E Braun, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

MCC-22-20126

Identifier Type: -

Identifier Source: org_study_id