Language: BG BG
← Back to results
Recruiting Not applicable NCT07224503

C-SMART vs BE Well for Patients With Brain Tumors

No applicable phase (e.g. observational)
Conditions: Brain Tumor

Sponsor: Virginia Commonwealth University

trial.available_in: БГ
Overview
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
Who can participate
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
Interventions
C-SMART
BEHAVIORAL
BE Well
BEHAVIORAL
Locations 1
United States (1)
Virginia Commonwealth University
Richmond , Virginia
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.12.2025
Completion date
31.10.2027
Registry ID
NCT07224503
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.