Virginia Commonwealth University
Richmond, Virginia, 23298, United States
NCT Number: NCT05984667
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Richmond, Virginia, 23298, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver Inclusion Criteria
Caregiver Exclusion Criteria
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.
Time frame: 10 months
As evidenced by rates of participant screening, eligibility, and consent
Time frame: 10 months
As evidenced by the number of participants that complete the neurocognitive assessments pre- and post-intervention
Time frame: 11 months
As evidenced by the number of patients that complete post-intervention measures
Time frame: 10 months
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.
Time frame: 10 months
As evidenced by the number of patients that would recommend the intervention to others
Time frame: 8 months
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)
Time frame: 10 months
Completion rate of neuroimaging at post-intervention
Time frame: 10 months
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.
Virginia Commonwealth University
Other
C-SMART for Patients With Primary Brain Tumors: A Feasibility and Acceptability Pilot of a Novel Neuropsychological Intervention
Acronym: C-SMART
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05100173
Glioma, Glioma, Malignant
Jilin City, China
View Trial DetailsNCT04461938
Glioma, Glioma, Mixed
Frankfurt am Main, Hesse, Germany
View Trial DetailsNCT02851706
Astrocytoma, Brain Cancer
Bethesda, Maryland, United States
View Trial DetailsNCT06368310
Brain Diseases, Brain Neoplasms
Salford, Greater Manchester, United Kingdom
View Trial Details