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Behavioral Intervention
C-SMART for Brain Cancer (C-SMART Trial)
N/A
Recruiting
Led By Sarah E Braun, PhD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11 months
Awards & highlights
Summary
This trial tests if a new online therapy (C-SMART) helps people with brain cancer and mild memory problems.
Who is the study for?
This trial is for adults with a glioma brain tumor who have finished radiation therapy at least a month ago. They should be able to perform daily activities well (KPS score ≥ 80), speak English, and show some cognitive decline compared to before their illness. People can't join if they can't attend online sessions, understand the study, or have severe sleep problems.
What is being tested?
The C-SMART program is being tested in this study. It's delivered via telehealth and combines cognitive strategies, mindfulness techniques, and rehabilitation therapy aimed at helping patients with mild neurocognitive disorders due to gliomas.
What are the potential side effects?
Since C-SMART involves non-invasive therapies like cognitive exercises and mindfulness training rather than drugs or surgery, significant side effects are not expected. However, participants may experience fatigue or emotional discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 11 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determine acceptability of C-SMART intervention - Attendance
Determine acceptability of C-SMART intervention - Satisfaction
Determine acceptability of C-SMART intervention - Satisfaction - Recommendation
+4 moreSecondary study objectives
Determine feasibility of C-SMART research procedures - Patient reported outcome completion
Trial Design
1Treatment groups
Experimental Treatment
Group I: C-SMARTExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
710 Previous Clinical Trials
22,886,921 Total Patients Enrolled
American Psychological FoundationOTHER
18 Previous Clinical Trials
1,901 Total Patients Enrolled
Sarah E Braun, PhDPrincipal InvestigatorVirginia Commonwealth University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself but may not be able to carry out normal activities.I have a confirmed primary brain tumor.I finished radiation therapy at least 1 month ago.I am able to understand and sign the consent form.I cannot attend virtual sessions.I have severe trouble sleeping.
Research Study Groups:
This trial has the following groups:- Group 1: C-SMART
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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