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C-SMART vs BE Well for Patients With Brain Tumors

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment increased: 42 → 56 participants
    • Eligibility criteria expanded, about 101 words
    • Secondary endpoints: details revised at 8 of 10 entries
  2. Trial status: Suspended to Recruiting
    • Primary and study completion pushed from Jul 31, 2027 to Oct 31, 2027
    • Site details revised
    v8
  3. Re-verified, no change to tracked fieldsv7
  4. Primary endpoints revised (6)
    • Sponsor's reason: Labs for intervention not currently open to Lab for MRI assessment is closed
    • Secondary endpoints revised (10)
    • Study arms: 2 to 4
    v6
  5. Trial status: Recruiting to Suspended Sponsor's reason: Labs for intervention not currently open
    • Site details revised
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
  2. Start date: Nov 1, 2025 to Dec 1, 2025v3
  3. Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 4 of 10 entries
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 (if eligible for research MRIs) 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
Trial Details
NCT Number NCT07224503
Lead Sponsor Virginia Commonwealth University
Collaborators: American Psychological Foundation
Conditions
(from sponsor)		 Brain Tumor
Related terms Brain Neoplasms
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov