Recruiting

C-SMART & BE Well

Sponsor:

Virginia Commonwealth University

Code:

NCT07224503

Conditions

Brain Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

C-SMART

BE Well

Study Details

Brief summary:

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

Conditions

Brain Tumor

Study ID

NCT07224503

Start date

Dec 1, 2025

Status verified date

Apr, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Patient

Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.

experimental: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - Caregiver

Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.

experimental: Brain health Education and Wellness (BE Well) - Patient

Time-matched educational videos focused on maximizing brain health in the context of brain tumor.

experimental: Brain health Education and Wellness (BE Well) - Caregiver

Time-matched educational videos focused on maximizing brain health in the context of brain tumor.

Interventions

C-SMART

Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing

BE Well

Eight weekly 45- to 60-minute video lectures

Primary outcome measure

  • Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients- Eligibility Rate [ Time Frame: 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 [ Time Frame: From screening to intervention initiation, 8 weeks ]
  • Assess the feasibility of the C-SMART and BE Well protocols in brain tumor patients -- retention rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: From baseline to post-intervention survey completion, 20 weeks ]

Central Contacts and Locations

Central contacts

Sarah Braun, Ph.D

804-628-7028sarah.braun@vcuhealth.org

Brighton Payne, BS

804-628-6799brightonph@vcu.edu

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Sarah Braun, Ph.D

804-628-7028sarah.braun@vcuhealth.org

Principal Investigator:

Sarah Braun, Ph.D

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-04-17.