Cognitive strategies and mindfulness therapy for brain tumor patients
C-SMART for Patients With Primary Brain Tumors: A Feasibility and Acceptability Pilot of a Novel Neuropsychological Intervention
This study is testing a new telehealth program that combines cognitive strategies and mindfulness therapy to see if it helps brain tumor patients with mild cognitive issues feel better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT05984667 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility and acceptability of a telehealth program called C-SMART for patients diagnosed with primary brain tumors and mild neurocognitive deficits. The study will involve 36 patients and their caregivers, with a subset of 10 participants undergoing resting-state functional MRI (rs-fMRI) to assess the impact of the intervention. The program focuses on cognitive rehabilitation and mindfulness techniques delivered remotely, allowing for flexibility and accessibility for participants. The study will gather data on both patient and caregiver experiences to inform future interventions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of primary brain tumor and mild neurocognitive deficits.
Not a fit: Patients with major neurocognitive impairments or severe communication difficulties may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance cognitive function and quality of life for patients with primary brain tumors.
How similar studies have performed: While similar approaches have been explored, this specific telehealth intervention for brain tumor patients is relatively novel.
Eligibility criteria
Show full 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.
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Sarah E Braun, PhD — Virginia Commonwealth University
- Study coordinator: Sarah E Braun, PhD
- Email: sarah.braun@vcuhealth.org
- Phone: 8046287028
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.