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

NCT05984667 | Completed DMC

• 1 other identifier: MCC-22-20126
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioma, Mixed; Brain Tumor; Mild Neurocognitive Disorder

Keywords

Mindfulness; Cognitive rehabilitation; rs-fMRI

Outcome Measures

Primary Outcomes (7)

• 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

  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 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 preliminary feasibility of longitudinal rs-fMRI procedures for a subset of patients

  Completion rate of neuroimaging at post-intervention

  10 months

Secondary Outcomes (1)

• Determine feasibility of C-SMART research procedures - Patient reported outcome completion

  10 months

Study Arms (2)

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

Caregiver

Informal caregiver that may enroll with the patient (not required)

Behavioral: C-SMART

Interventions

C-SMART 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.

Caregiver; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Confirmed primary brain tumor diagnosis by histology or neuro-oncologist review of imaging
• 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
• \>1 month post brain surgery and/or radiation therapy, if applicable
• Estimated premorbid intelligence \>75.
• Patients must be age 18+ and primarily English speaking

You may not qualify if:

• 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
• Inability to attend weekly telehealth appointments; based on EAB results
• Clinically significant insomnia symptoms
• \< 1 month post brain surgery and/or radiation therapy
• Unstable internet connection or an inability to work teleconferencing software. Participants will be supplied an iPad if they do not have an adequate device.
• 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.
• Must be an adult caregiver of an enrolled patient (see criteria above)
• Primarily English speaking
• \. Paid caregiver (e.g. home health aide)

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• American Psychological Foundation: collaborator
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Glioma; Neurocognitive Disorders; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Mental Disorders; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sarah E Braun, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: September 15, 2023
• Primary Completion: July 23, 2025
• Study Completion: July 23, 2025
• Last Updated: February 20, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)