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

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

The goal of Phase Ib Trial is to determine the feasibility and acceptability of telehealth C-SMART for patients with primary brain tumor and mild neurocognitive deficits (N=18) and their caregivers (N=14) A subset (n=3) of participants will undergo rs-fMRI both pre- and post-C-SMART to test feasibility of advanced functional imaging in this population.

Study Overview

• Status: Completed
• Conditions: Brain Tumor; Mild Neurocognitive Disorder; Glioma, Mixed
• Intervention / Treatment: Behavioral: C-SMART

• Study Type: Observational
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with primary brain tumor and mild neurocognitive disorder (mNCD) and informal caregivers

Description

Patient 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

Patient 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.

Caregiver Inclusion Criteria

1. Must be an adult caregiver of an enrolled patient (see criteria above)
2. Primarily English speaking

Caregiver Exclusion Criteria

1. Paid caregiver (e.g. home health aide)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient; 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.	Behavioral: 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.
Caregiver; Informal caregiver that may enroll with the patient (not required)	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine feasibility of C-SMART recruitment	As evidenced by rates of participant screening, eligibility, and consent	10 months
Determine feasibility of C-SMART - Data collection procedures	As evidenced by the number of participants that complete the neurocognitive assessments pre- and post-intervention	10 months
Determine feasibility of C-SMART - Retention Rate	As evidenced by the number of patients that complete post-intervention measures	11 months
Determine acceptability of C-SMART intervention - Satisfaction - Recommendation	As evidenced by the number of patients that would recommend the intervention to others	10 months
Optimization of C-SMART research procedures	The number of participants that complete exit interviews will be audio recorded and transcribed verbatim. The PI and a second independent coder will separately review each transcript to identify common themes and develop a coding framework of free responses. All results will be reviewed for agreement and comparison to the raw data, and discrepancies will be resolved through discussion with the PI until reliability is reached (Kappa>.80)	8 months
Determine acceptability of C-SMART intervention - Satisfaction	After each intervention session, participants will be sent a link for a brief post-session satisfaction survey via secure email link. In this survey, participants will rate 1) topic applicability; 2) perceived benefit of session; 3) comfort with interventionist(s); 4) overall satisfaction and 5) likelihood of recommending the program to others. Responses are ranked on a Likert-type scale from 1 being "Not at all" to 5 being "A great deal". Higher scores indicate greater satisfaction with the intervention session.	10 months
Determine preliminary feasibility of longitudinal rs-fMRI procedures for a subset of patients	Completion rate of neuroimaging at post-intervention	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine feasibility of C-SMART research procedures - Patient reported outcome completion	Feasibility of research procedures will be assessed by the number of participants that complete the baseline survey, post-session survey, and the post-intervention survey.	10 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: American Cancer Society, Inc.; American Psychological Foundation
• Investigators: Principal Investigator: Sarah E Braun, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): July 23, 2025
• Study Completion (Actual): July 23, 2025

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Mindfulness; Cognitive rehabilitation; rs-fMRI
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Central Nervous System Neoplasms; Glioma; Brain Neoplasms; Neurocognitive Disorders
• Other Study ID Numbers: MCC-22-20126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data (IPD) to other researchers at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No