C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors

Brain Tumor Clinical Trial

— C-SMART  

Official title:

Development of C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984667
• Other study ID #: MCC-22-20126
• Status: Recruiting
• Start date: September 15, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: Sarah E Braun, PhD
• Phone: 8046287028
• Email: sarah.braun[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary aims of this mixed-methods trial are to test the feasibility and acceptability of the novel Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) delivered via telehealth to patients with primary brain tumors and mild neurocognitive disorder (mNCD).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults with a primary brain tumor confirmed by histology or neuro-oncologist's report
• At least one domain of neurocognitive function = 1.5 SD below estimate premorbid functioning or = 1.5 SD below population mean
• Karnofsky's Performance Status (KPS) score > 40
• = 1 month out of radiation therapy
• Ability to read, speak, and understand English

Exclusion Criteria:

• Inability to attend virtual sessions
• Inability to understand and provide informed consent
• Presence of clinically significant insomnia

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Glioma
• Glioma, Mixed
• Mild Neurocognitive Disorder
• Neurocognitive Disorders

Intervention

Behavioral:
• C-SMART
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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	American Psychological Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine feasibility of C-SMART recruitment	As evidenced by rates of participant screening, eligibility, and consent	10 months
Primary	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
Primary	Determine acceptability of C-SMART intervention - Attendance	As evidenced by the attendance rate at intervention sessions	10 months
Primary	Determine feasibility of C-SMART - Retention Rate	As evidenced by the number of patients that complete post-intervention measures	11 months
Primary	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
Primary	Determine acceptability of C-SMART intervention - Satisfaction - Recommendation	As evidenced by the number of patients that would recommend the intervention to others	10 months
Primary	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)	8 months
Secondary	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