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

Recruiting

• Conditions: Glioma, Mixed; Brain Tumor; Mild Neurocognitive Disorder
• Interventions: Behavioral: C-SMART

• Registration Number: NCT05984667
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-09
• Study Start: 2023-09-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
C-SMART	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.

Primary Outcome Measures

Name	Time	Method
Determine feasibility of C-SMART recruitment	10 months	As evidenced by rates of participant screening, eligibility, and consent
Determine feasibility of C-SMART - Data collection procedures	10 months	As evidenced by the number of participants that complete the neurocognitive assessments pre- and post-intervention
Determine feasibility of C-SMART - Retention Rate	11 months	As evidenced by the number of patients that complete post-intervention measures
Determine acceptability of C-SMART intervention - Satisfaction	10 months	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.
Determine acceptability of C-SMART intervention - Satisfaction - Recommendation	10 months	As evidenced by the number of patients that would recommend the intervention to others
Optimization of C-SMART research procedures	8 months	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)
Determine preliminary feasibility of longitudinal rs-fMRI procedures for a subset of patients	10 months	Completion rate of neuroimaging at post-intervention

Secondary Outcome Measures

Name	Time	Method
Determine feasibility of C-SMART research procedures - Patient reported outcome completion	10 months	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.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States