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

Study Purpose

The primary aims of this mixed-methods trial are to test the feasibility and acceptability of the novel Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) delivered via telehealth to patients with primary brain tumors and mild neurocognitive disorder (mNCD).

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:

- Adults with a primary brain tumor confirmed by histology or neuro-oncologist's report.

- At least one domain of neurocognitive function ≥ 1.5 SD below estimate premorbid functioning or ≥ 1.5 SD below population mean.

- Karnofsky's Performance Status (KPS) score > 40.

- ≥ 1 month out of radiation therapy.

- Ability to read, speak, and understand English.

Exclusion Criteria:

- Inability to attend virtual sessions.

- Inability to understand and provide informed consent.

- Presence of clinically significant insomnia

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