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

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Conditions

Glioma, MixedMild Neurocognitive DisorderBrain TumorMindfulnessCognitive rehabilitationrs-fMRI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of Phase IIa Trial is to determine the feasibility and acceptability of telehealth C-SMART for patients with primary brain tumor and mild neurocognitive deficits (N=36) and their caregivers (N=36) A subset (n=10) of participants will undergo rs-fMRI both pre- and post-C-SMART to test feasibility of advanced functional imaging in this population.

Official Title

C-SMART for Patients With Primary Brain Tumors: A Feasibility and Acceptability Pilot of a Novel Neuropsychological Intervention

Quick Facts

Study Start:2023-09-15
Study Completion:2025-07-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05984667

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Confirmed primary brain tumor diagnosis by histology or neuro-oncologist review of imaging
  2. 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. 3. \>1 month post brain surgery and/or radiation therapy, if applicable
  4. 4. Estimated premorbid intelligence \>75.
  5. 5. Patients must be age 18+ and primarily English speaking
  1. 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. 2. Inability to attend weekly telehealth appointments; based on EAB results
  3. 3. Clinically significant insomnia symptoms
  4. 4. \< 1 month post brain surgery and/or radiation therapy
  5. 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. 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.

Contacts and Locations

Principal Investigator

Sarah E Braun, PhD
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Sarah E Braun, PhD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-15
Study Completion Date2025-07-23

Study Record Updates

Study Start Date2023-09-15
Study Completion Date2025-07-23

Terms related to this study

Keywords Provided by Researchers

  • Mindfulness
  • Cognitive rehabilitation
  • rs-fMRI

Additional Relevant MeSH Terms

  • Glioma, Mixed
  • Mild Neurocognitive Disorder
  • Brain Tumor