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| Name | Class |
|---|---|
| American Psychological Foundation | OTHER |
| American Cancer Society, Inc. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | 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. |
| |
| Caregiver | Informal caregiver that may enroll with the patient (not required) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-SMART | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine feasibility of C-SMART recruitment | As evidenced by rates of participant screening, eligibility, and consent | 10 months |
| Determine feasibility of C-SMART - Data collection procedures | As evidenced by the number of participants that complete the neurocognitive assessments pre- and post-intervention | 10 months |
| Determine feasibility of C-SMART - Retention Rate | As evidenced by the number of patients that complete post-intervention measures | 11 months |
| Determine acceptability of C-SMART intervention - Satisfaction | After each intervention session, participants will be sent a link for a brief post-session satisfaction survey via secure email link. In this survey, participants will rate 1) topic applicability; 2) perceived benefit of session; 3) comfort with interventionist(s); 4) overall satisfaction and 5) likelihood of recommending the program to others. Responses are ranked on a Likert-type scale from 1 being "Not at all" to 5 being "A great deal". Higher scores indicate greater satisfaction with the intervention session. | 10 months |
| Determine acceptability of C-SMART intervention - Satisfaction - Recommendation | As evidenced by the number of patients that would recommend the intervention to others | 10 months |
| Optimization of C-SMART research procedures | The number of participants that complete exit interviews will be audio recorded and transcribed verbatim. The PI and a second independent coder will separately review each transcript to identify common themes and develop a coding framework of free responses. All results will be reviewed for agreement and comparison to the raw data, and discrepancies will be resolved through discussion with the PI until reliability is reached (Kappa>.80) |
| Measure | Description | Time Frame |
|---|---|---|
| Determine feasibility of C-SMART research procedures - Patient reported outcome completion | Feasibility of research procedures will be assessed by the number of participants that complete the baseline survey, post-session survey, and the post-intervention survey. | 10 months |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver Inclusion Criteria
Caregiver Exclusion Criteria
1. Paid caregiver (e.g. home health aide)
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Patients with primary brain tumor and mild neurocognitive disorder (mNCD) and informal caregivers
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| Name | Affiliation | Role |
|---|---|---|
| Sarah E Braun, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
There is no plan to share individual participant data (IPD) to other researchers at this time.
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D019965 | Neurocognitive Disorders |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| 8 months |
| Determine preliminary feasibility of longitudinal rs-fMRI procedures for a subset of patients | Completion rate of neuroimaging at post-intervention | 10 months |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001523 | Mental Disorders |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |