FearLess in NeuroOncology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About this trial
The overarching goal of this project is to assess the feasibility, acceptability, and appropriateness of recruitment methods, target population, and a waitlist design to finalize the protocol of FearLess in primary malignant brain tumor patients and caregivers
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Self-report a diagnosis of a primary malignant brain tumor (grade II-IV)
>2 weeks post-cranial resection or biopsy
Elevated Fear of Recurrence Distress Rating
Primarily English speaking
Disqualifiers
Cognitive impairment that might prohibit active intervention engagement
Inability to understand and provide informed consent
Inability to attend virtual sessions due to unstable or no internet connection
Trial design
Design model
Parallel
Treatments tested in this trial
Fearless in Neuro-Oncology
BehavioralFearLess is a newly developed, empirically-rooted, manualized psychological intervention consisting of an intake + 8 sessions delivered over a 12-week time period. It consists of weekly individual 60- to 90-minute virtual therapy sessions.
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: Fearless Immediate Treatment ArmExperimental treatment 1 intervention
Group B: FearLess Delayed Control ArmOther 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility - Study Enrollment
Feasibility of study enrollment using a multimodal recruitment approach will be assessed by comparing observed rates of screening completion, trial eligibility, trial enrollment (i.e., informed consent), and randomization allocation to pre-specified benchmarks.
Time frame
From screening to randomization allocation2
Feasibility - Study Retention at 12 Weeks
Study retention will be measured by comparing observed rates of 12-week assessment completion to pre-specified benchmarks.
Time frame
From baseline assessment to 12 weeks3
Feasibility - Study Retention at 24 Weeks
Study retention will be measured by comparing observed rates of 24-week assessment completion to pre-specified benchmarks.
Time frame
From baseline assessment to 24 weeks4
Feasibility - Sustained Eligibility (Delayed Treatment Control Arm Only)
Feasibility of sustained trial eligibility will be assessed in the delayed treatment control arm only by comparing the proportion of participants who remain eligible at 12 weeks to a pre-determined threshold.
Time frame
From baseline to 12-week assessmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Virginia Commonwealth University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
National Brain Tumor Society
Collaborator
Source ClinicalTrials.gov