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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05984667
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Virginia Commonwealth University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sarah E Braun, PhD
Principal Investigator Affiliation	Virginia Commonwealth University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Mixed, Mild Neurocognitive Disorder, Brain Tumor

Arms & Interventions

Arms

: C-SMART

C-SMART intervention will be provided via telehealth. Participants will complete in-person neurocognitive testing (baseline, post-intervention) as well as surveys (baseline, post-session, post-intervention) via secure email link. Exit interviews will be conducted by Zoom.

Interventions

Behavioral: - C-SMART

The C-SMART intervention includes approximately 8 individual therapy sessions, each approximately 60 minutes in length, delivered weekly. C-SMART intervention components include cognitive rehabilitation and mindfulness training.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Virginia Commonwealth University, Richmond, Virginia

Status

Recruiting

Address

Virginia Commonwealth University

Richmond, Virginia, 23298

Site Contact

Sarah Braun, Ph.D

[email protected]

804-628-7028

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