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Psychological Intervention
FearLess Intervention for Brain Tumor-Related Anxiety (FearLess Trial)
N/A
Waitlist Available
Led By Ashlee Loughan, 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 12 weeks
Awards & highlights
FearLess Trial Summary
This trial will study an intervention to help people with brain tumors reduce fear of cancer recurrence.
Who is the study for?
This trial is for English-speaking adults over 18 with glioma (a type of brain tumor) who have a significant fear of cancer coming back. They must be at least two weeks post-surgery or biopsy and have someone close to them, like a family member or friend, who isn't paid to provide care.Check my eligibility
What is being tested?
The study tests 'FearLess', a new psychological strategy designed to help patients with glioma manage their intense fear that the cancer might return. It aims to see if this approach is practical and well-received by participants.See study design
What are the potential side effects?
Since 'FearLess' is a psychological intervention rather than a drug, it may not have typical medical side effects. However, discussing fears about cancer recurrence could potentially cause emotional discomfort.
FearLess Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine feasibility of FearLess recruitment
Interventional procedure
Determine the acceptability of FearLess intervention- Retention Rate
+3 moreOther outcome measures
Interventional procedure
FearLess Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm 3Experimental Treatment1 Intervention
Caregivers Only
Group II: Arm 2Experimental Treatment1 Intervention
Patients and Caregivers
Group III: Arm 1Experimental Treatment1 Intervention
Patients Only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FearLess Intervention
2022
N/A
~30
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
698 Previous Clinical Trials
22,884,986 Total Patients Enrolled
Ashlee Loughan, PhDPrincipal InvestigatorVirginia Commonwealth University
4 Previous Clinical Trials
93 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 18 years old or older.You are experiencing high levels of fear of cancer returning as indicated by a score of over 13 on a fear of cancer recurrence inventory.You must be able to speak English well.You are a family member or unpaid caregiver for someone who has been diagnosed with a certain type of brain tumor called glioma.You have been diagnosed with a type of brain tumor called glioma, which has been confirmed by a tissue sample.You must wait at least 2 weeks after a surgical repair or biopsy (if applicable).
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2
- Group 2: Arm 1
- Group 3: Arm 3
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is registration for this trial still available to those interested?
"The information on clinicaltrials.gov attests that this study is not presently open for enrollment. The trial was initially made public on December 1st 2022 and recently modified as of October 27th 2022. At present, there are no vacancies in this experiment; however, a total of 356 other studies have positions available right now."
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