Clinical trial NCT05984667: C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors
Official title: C-SMART for Patients With Primary Brain Tumors: A Feasibility and Acceptability Pilot of a Novel Neuropsychological Intervention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioma, Mixed
Mild Neurocognitive Disorder
Brain Tumor
Keywords: Mindfulness
Cognitive rehabilitation
rs-fMRI
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: American Psychological Foundation
name: American Cancer Society, Inc.
First posted: 2023-08-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary brain tumor and mild neurocognitive disorder (mNCD)

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Determine feasibility of C-SMART recruitment
timeFrame: 10 months
measure: Determine feasibility of C-SMART - Data collection procedures
timeFrame: 10 months
measure: Determine feasibility of C-SMART - Retention Rate
timeFrame: 11 months
measure: Determine acceptability of C-SMART intervention - Satisfaction
timeFrame: 10 months
measure: Determine acceptability of C-SMART intervention - Satisfaction - Recommendation
timeFrame: 10 months
measure: Optimization of C-SMART research procedures
timeFrame: 8 months
measure: Determine preliminary feasibility of longitudinal rs-fMRI procedures for a subset of patients
timeFrame: 10 months
Secondary outcomes:
measure: Determine feasibility of C-SMART research procedures - Patient reported outcome completion
timeFrame: 10 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Sarah E Braun, PhD
role: PRINCIPAL_INVESTIGATOR
References: