Clinical trial · Observational
C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors
C-SMART for Patients With Primary Brain Tumors: A Feasibility and Acceptability Pilot of a Novel Neuropsychological Intervention
NCT05984667CI-TRIAL-00103793C-SMARTcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Glioma, Mixed | Mixed Glioma | ALIAS | 0.90 |
| Mild Neurocognitive Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C-SMART | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patient
- description
- 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.
- interventionNames
- Behavioral: C-SMART
- label
- Caregiver
- description
- Informal caregiver that may enroll with the patient (not required)
- interventionNames
- Behavioral: C-SMART
Primary outcomes (7)
- measure
- Determine feasibility of C-SMART recruitment
- timeFrame
- 10 months
- description
- As evidenced by rates of participant screening, eligibility, and consent
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Patient 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 Patient 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. Caregiver Inclusion Criteria 1. Must be an adult caregiver of an enrolled patient (see criteria above) 2. Primarily English speaking Caregiver Exclusion Criteria 1\. Paid caregiver (e.g. home health aide)
References
Publications (0)
Data not yet available
No reference posted for this study.