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

Study Overview
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Brief Summary
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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 glioma and mild neurocognitive disorder (mNCD).

Official Title
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Development of C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Glioma

Conditions
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Glioma, Mixed, Mild Neurocognitive Disorder

Intervention / Treatment
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* Behavioral: C-SMART


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with a glioma diagnosis confirmed by histology At least one domain of neurocognitive function ≥ 1.5 SD below estimate premorbid functioning Karnofsky' Performance Status (KPS) score ≥ 80 ≥ 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| C-SMART<br>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. | Behavioral: C-SMART<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 acceptability of C-SMART intervention - Attendance | As evidenced by the attendance rate at intervention sessions | 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) | 8 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Cognitive rehabilitation