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Search / Trial NCT05984667

C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · Aug 1, 2023

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Mindfulness Cognitive Rehabilitation Rs F Mri

ClinConnect Summary

The C-SMART trial is studying a new approach called Cognitive Strategies, Mindfulness, and Rehabilitation Therapy to help patients with primary brain tumors and mild neurocognitive disorder. This therapy will be delivered through telehealth, which means patients can participate from the comfort of their own homes. The goal of the trial is to see if this therapy is practical and if patients find it helpful.

To be eligible for the trial, participants should be adults aged 65 to 74 who have been diagnosed with a primary brain tumor and have some difficulties with thinking or memory. They should also be at least one month post-radiation therapy and able to understand and speak English. Participants will join virtual sessions where they can learn new coping strategies and mindfulness techniques. It's important to note that those who cannot attend these online sessions or have significant sleep issues will not be able to participate. This trial is currently recruiting, so if you or someone you know fits the criteria and is interested, it could be a great opportunity to explore new ways to manage their condition.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Confirmed primary brain tumor diagnosis by histology or neuro-oncologist review of imaging
  • 2. At least one domain of neurocognitive function \>1.5 SD below the average or the individual's estimated premorbid functioning, using the expanded ICCTF clinical trials battery and Test of Premorbid Functioning for comparison
  • 3. \>1 month post brain surgery and/or radiation therapy, if applicable
  • 4. Estimated premorbid intelligence \>75.
  • 5. Patients must be age 18+ and primarily English speaking
  • Exclusion Criteria:
  • 1. 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
  • 2. Inability to attend weekly telehealth appointments; based on EAB results
  • 3. Clinically significant insomnia symptoms
  • 4. \< 1 month post brain surgery and/or radiation therapy
  • 5. Unstable internet connection or an inability to work teleconferencing software. Participants will be supplied an iPad if they do not have an adequate device.
  • 6. To participate in the fMRI portion of this study participants cannot have any metal in their bodies. For the fMRI subset, participants cannot have metal in their body as the MRI scan could cause them harm and if female of childbearing years, they cannot be pregnant as the MRI scan may pose risk to the unborn fetus.

About Virginia Commonwealth University

Virginia Commonwealth University (VCU) is a prominent academic institution and research leader located in Richmond, Virginia. Renowned for its commitment to advancing healthcare through innovative research and education, VCU plays a pivotal role in clinical trials aimed at improving patient outcomes and understanding complex health issues. The university boasts a collaborative environment, leveraging its diverse faculty expertise and state-of-the-art facilities to conduct rigorous clinical research across various medical disciplines. VCU's dedication to ethical research practices and community engagement ensures that its clinical trials are designed to address critical health challenges while prioritizing participant safety and well-being.

Locations

Richmond, Virginia, United States

Patients applied

0 patients applied

Trial Officials

Sarah E Braun, PhD

Principal Investigator

Virginia Commonwealth University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported