C-SMART vs BE Well for Patients With Brain Tumors

Phase II Randomized Controlled Trial of C-SMART Versus BE Well for Patients With Brain Tumors on Neurocognitive and Neuroimaging Outcomes

The goal of this clinical trial is to learn about the acceptability and feasibility of Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) and Brain health Education and Wellness (BE Well) in adults with brain tumors and their caregivers.

Participants will be assigned to one of the two groups:

• Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) is a recently developed virtual intervention combining both cognitive rehabilitation with mindfulness meditation training. The manualized program consists of 8 weekly 1:1 tele intervention sessions, targeting cognitive weaknesses identified from baseline cognitive testing.
• Brain health Education and Wellness (BE Well) intervention consists of 8 weekly videos focused on maximizing brain health in the context of brain tumor.

Participants will also be asked to:

• participate in two in-person visits involving an MRI and neurocognitive tests
• complete a survey the the beginning and end of the study
• if in BE Well group, answer a few questions after watching each video

Study Overview

• Status: Recruiting
• Conditions: Brain Tumor
• Intervention / Treatment: Behavioral: C-SMART; Behavioral: BE Well

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Braun, Ph.D; Phone Number: 804-628-7028; Email: sarah.braun@vcuhealth.org
• Study Contact Backup: Name: Brighton Payne, BS; Phone Number: 804-628-6799; Email: brightonph@vcu.edu

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University
      • Contact: Sarah Braun, Ph.D; Phone Number: 804-628-7028; Email: sarah.braun@vcuhealth.org
      • Principal Investigator: Sarah Braun, Ph.D

Participation Criteria

Eligibility Criteria

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

Description

Patient Inclusion Criteria:

• Patient of Virginia Commonwealth University Neuro-Oncology clinic
• 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 International Cognition and Cancer Task Force (ICCTF) clinical trials battery and Test of Premorbid Functioning62 for comparison; (3) >1 month post brain surgery and/or radiation therapy, if applicable;
• Estimated premorbid intelligence >75.
• Patients must be age 18+ and
• Primarily English speaking.

Patient Exclusion Criteria:

• 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
• Clinically significant insomnia symptoms coupled with report that insomnia is more interfering than cognitive 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.
• Participants cannot have metal in their body as the MRI scan could cause them harm
• If female of childbearing years, they cannot be pregnant as the MRI scan may pose risk to the unborn fetus

Caregiver Inclusion Criteria

• Must enroll with a patient (see criteria above)
• Must be age 18+ and
• Primarily English speaking

Caregiver Exclusion Criteria

-N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Patient; Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.	Behavioral: C-SMART; Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing
Experimental: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Caregiver; Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.	Behavioral: C-SMART; Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing
Experimental: Brain health Education and Wellness (BE Well) - Patient; Time-matched educational videos focused on maximizing brain health in the context of brain tumor.	Behavioral: BE Well; Eight weekly 45- to 60-minute video lectures
Experimental: Brain health Education and Wellness (BE Well) - Caregiver; Time-matched educational videos focused on maximizing brain health in the context of brain tumor.	Behavioral: BE Well; Eight weekly 45- to 60-minute video lectures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients- Eligibility Rate	The percentage of participants that are eligible to enroll	From time participant indicates interest to screening completion, 4 weeks
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients - Enrollment Rate	The percentage of participants that enroll	From screening to intervention initiation, 8 weeks
Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients -- retention rate	The percentage of participants that complete the post-intervention data collection	From baseline to end of study, 28 weeks
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients -- intervention completion rate	The percentage of participants that complete the the protocol assigned interventions	From baseline to end of intervention, 16 weeks
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients - Participant satisfaction ratings	Participant ratings of satisfaction. Participants will rate the following questions on a scale from completely disagree to completely agree: C-SMART/BE Well Meets my approval; C-SMART/BE Well is appealing to the patient; "I like C-SMART/BE Well"; "I welcome C-SMART/BE Well". Additionally, participants will answer the following question on a scale from extremely dissatisfied to extremely satisfied: "When you signed up for the study, you were told that you would be randomized to either C-SMART or BE Well Videos. How satisfied are you with the group you were randomized to?"	From baseline to post-intervention survey completion, 20 weeks
Assess the acceptability of the C-SMART and BE Well protocols in brain tumor patients - Participant recommendation ratings.	Participant ratings of intervention recommendation Participants will answer the following question: Would "you" (the patient) recommend C-SMART/BE Well to other brain tumor patients?	From baseline to post-intervention survey completion, 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate effect of interventions on neurocognitive tests Hopkins Verbal Learning Test (verbal learning and memory)	Changes in neurocognitive assessment scores (pre vs post intervention) between groups based on the Hopkins Verbal Learning Test (verbal learning and memory) neurocognitive test. Participant performance on the verbal learning and memory task will consist of three learning trials and a delay. A high score on the learning trials but a very low score on the delayed recall would show that the person can learn but has difficulty retrieving previously learned information.	Baseline to post-intervention assessment, up to 28 weeks
Investigate effect of interventions on neurocognitive test Controlled Oral Word Association (verbal fluency)	Changes in neurocognitive assessment scores (pre vs post intervention) between groups based on the Controlled Oral Word Association (verbal fluency) neurocognitive test. Participant performance on the verbal fluency task will consist of generating words in 60 seconds on phonemic trials (words that start with a specific letter) and semantic trials (words that fall into a specific category). Scores are the number of correctly retrieved words. A higher raw score indicates greater verbal fluency.	Baseline to post-intervention assessment, up to 28 weeks
Investigate effect of interventions on neurocognitive test Trail Making (attention and task switching)	Changes in neurocognitive assessment scores (pre vs post intervention) between groups based on Trail Making (processing speed and task switching). Participant performance will consist of time (in seconds) to complete a processing speed and switching task in which participants are asked to draw lines in sequential order, and then switch between two overlearned sequences. A shorter time to completion would indicate greater processing speed and task switching.	Baseline to post-intervention assessment, up to 28 weeks
Investigate effect of interventions on subjective cognition	Changes in subjective cognition (pre vs post intervention) between groups based on the Neuro-Qol Short Form the National Institutes of Health (NIH) toolbox. Participants rate their experience of cognitive slips on 4 questions from "never" to "very often", and 4 questions from "no difficulty" to "cannot do". Higher scores indicate greater subjective cognition. Scores range from 8-40. Raw scores can be converted into standardized scores (T-scores) with a mean of 50 and a standard deviation (SD) of 10. Thus, a person who has a T-score of 60 is one SD above the average of the US general population.	Baseline to post-intervention assessment, up to 20 weeks
Investigate effect of interventions on fatigue	Changes in fatigue (pre vs post intervention) between groups based on the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue short form. Participants rate their experience of fatigue on 4 items from "not at all" to "very much". Higher scores indicate greater fatigue. Scores range from 4-20. Raw scores can be converted into standardized scores (T-scores) with a mean of 50 and a standard deviation (SD) of 10. Thus, a person who has a T-score of 60 is one SD above the average of the US general population.	Baseline to post-intervention assessment, up to 20 weeks
Structural brain changes	Change in brain volume (pre vs. post intervention) between groups based on brain imaging (MRI) data. The volume of lateral ventricle in the hemisphere opposite to the tumor will be measured, using 3D Slicer (https://www.slicer.org) to calculate the ventricular volume at each time point which will serve as an index of diffuse cerebral volume loss.	From baseline to post-outcome assessment, 28 weeks
Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor - Enrollment Rate	The percentage of participants that enroll	From screening to intervention initiation, 8 weeks
Assess the feasibility of the C-SMART and BE Well protocols in caregivers of brain tumor patients -- retention rate	The percentage of participants that complete the post-intervention data collection	From baseline to end of study, 28 weeks
Assess the acceptability of the C-SMART and BE Well protocols in caregivers of brain tumor patients - Participant satisfaction ratings	Participant ratings of satisfaction. Participants will rate the following questions on a scale from completely disagree to completely agree: C-SMART/BE Well Meets my approval; C-SMART/BE Well is appealing to the patient; "I like C-SMART/BE Well"; "I welcome C-SMART/BE Well". Additionally, participants will answer the following question on a scale from extremely dissatisfied to extremely satisfied: "When you signed up for the study, you were told that your loved one would be randomized to either C-SMART or BE Well Videos. How satisfied are you with the group your loved one was randomized to?"	From baseline to post-intervention survey completion, 20 weeks
Assess the acceptability of the C-SMART and BE Well protocols in caregivers of brain tumor patients - Participant recommendation ratings.	Participant ratings of intervention recommendation. Participants will answer the following question: Would "you" (the caregiver) recommend C-SMART/BE Well to other caregivers?	From baseline to post-intervention survey completion, 20 weeks

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: American Psychological Foundation
• Investigators: Principal Investigator: Sarah Braun, Ph.D, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: October 31, 2025
• First Submitted That Met QC Criteria: October 31, 2025
• First Posted (Actual): November 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: MCC-25-22557; HM300000218 (Other Identifier: Virginia Commonwealth University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to share individual patient data "IPD" 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