C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary … (NCT05984667) | Clinical Trial Compass
CompletedNot Applicable
C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors
United States32 participantsStarted 2023-09-15
Plain-language summary
The goal of Phase Ib Trial is to determine the feasibility and acceptability of telehealth C-SMART for patients with primary brain tumor and mild neurocognitive deficits (N=18) and their caregivers (N=14) A subset (n=3) of participants will undergo rs-fMRI both pre- and post-C-SMART to test feasibility of advanced functional imaging in this population.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Confirmed primary brain tumor diagnosis by histology or neuro-oncologist review of imaging
✓. 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
✓. \>1 month post brain surgery and/or radiation therapy, if applicable
✓. Estimated premorbid intelligence \>75.
✓. Patients must be age 18+ and primarily English speaking
Exclusion criteria
✕. 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
✕. Inability to attend weekly telehealth appointments; based on EAB results
✕. Clinically significant insomnia symptoms
✕. \< 1 month post brain surgery and/or radiation therapy
✕. Unstable internet connection or an inability to work teleconferencing software. Participants will be supplied an iPad if they do not have an adequate device.
✕. 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.
What they're measuring
1
Determine feasibility of C-SMART recruitment
Timeframe: 10 months
2
Determine feasibility of C-SMART - Data collection procedures
Timeframe: 10 months
3
Determine feasibility of C-SMART - Retention Rate
Timeframe: 11 months
4
Determine acceptability of C-SMART intervention - Satisfaction
Timeframe: 10 months
5
Determine acceptability of C-SMART intervention - Satisfaction - Recommendation
Timeframe: 10 months
6
Optimization of C-SMART research procedures
Timeframe: 8 months
7
Determine preliminary feasibility of longitudinal rs-fMRI procedures for a subset of patients