C-SMART vs BE Well for Patients With Brain Tumors

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT07224503
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • C-SMART — BEHAVIORAL
    Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing
  • BE Well — BEHAVIORAL
    Eight weekly 45- to 60-minute video lectures

Study Details

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

Key Dates

Start date
Dec 1, 2025
Status verified
Apr 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298
Sarah Braun, Ph.D
804-628-7028
Sarah Braun, Ph.D (PRINCIPAL_INVESTIGATOR)

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