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 — BEHAVIORALEight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing
- BE Well — BEHAVIORALEight 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) - PatientModular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.
- Experimental: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) - CaregiverModular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.
- Experimental: Brain health Education and Wellness (BE Well) - PatientTime-matched educational videos focused on maximizing brain health in the context of brain tumor.
- Experimental: Brain health Education and Wellness (BE Well) - CaregiverTime-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
- Sarah Braun, Ph.D804-628-7028
- Brighton Payne, BS804-628-6799
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | Sarah Braun, Ph.D (PRINCIPAL_INVESTIGATOR) |
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