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

Primary Purpose

Glioma, Mixed, Mild Neurocognitive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
C-SMART
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glioma, Mixed focused on measuring Mindfulness, Cognitive rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

C-SMART

Arm 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.

Outcomes

Primary Outcome Measures

Determine feasibility of C-SMART recruitment
As evidenced by rates of participant screening, eligibility, and consent
Determine feasibility of C-SMART - Data collection procedures
As evidenced by the number of participants that complete the neurocognitive assessments pre- and post-intervention
Determine acceptability of C-SMART intervention - Attendance
As evidenced by the attendance rate at intervention sessions
Determine feasibility of C-SMART - Retention Rate
As evidenced by the number of patients that complete post-intervention measures
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.
Determine acceptability of C-SMART intervention - Satisfaction - Recommendation
As evidenced by the number of patients that would recommend the intervention to others
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)

Secondary Outcome Measures

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.

Full Information

First Posted
August 1, 2023
Last Updated
September 15, 2023
Sponsor
Virginia Commonwealth University
Collaborators
American Psychological Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05984667
Brief Title
Development of C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Glioma
Acronym
C-SMART
Official Title
Development of C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
American Psychological Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 glioma and mild neurocognitive disorder (mNCD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Mixed, Mild Neurocognitive Disorder
Keywords
Mindfulness, Cognitive rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
C-SMART
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
C-SMART
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine feasibility of C-SMART recruitment
Description
As evidenced by rates of participant screening, eligibility, and consent
Time Frame
10 months
Title
Determine feasibility of C-SMART - Data collection procedures
Description
As evidenced by the number of participants that complete the neurocognitive assessments pre- and post-intervention
Time Frame
10 months
Title
Determine acceptability of C-SMART intervention - Attendance
Description
As evidenced by the attendance rate at intervention sessions
Time Frame
10 months
Title
Determine feasibility of C-SMART - Retention Rate
Description
As evidenced by the number of patients that complete post-intervention measures
Time Frame
11 months
Title
Determine acceptability of C-SMART intervention - Satisfaction
Description
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
Title
Determine acceptability of C-SMART intervention - Satisfaction - Recommendation
Description
As evidenced by the number of patients that would recommend the intervention to others
Time Frame
10 months
Title
Optimization of C-SMART research procedures
Description
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
8 months
Secondary Outcome Measure Information:
Title
Determine feasibility of C-SMART research procedures - Patient reported outcome completion
Description
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.
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah E Braun, PhD
Phone
8046287028
Email
sarah.braun@vcuhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Giuliana V Zarrella, BA
Phone
8046254910
Email
giuliana.zarrella@vcuhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah E Braun, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Braun, Ph.D
Phone
804-628-7028
Email
sarah.braun@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
Giuliana Zarrella
Phone
8046254910
Email
giuliana.zarrella@vcuhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data (IPD) to other researchers at this time.

Learn more about this trial

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

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