NCT06989086 · Virginia Commonwealth University
FearLess in NeuroOncology
What this study is about
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
View original scientific description
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
Interventions
BEHAVIORAL
Fearless in Neuro-Oncology
FearLess 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.
Primary outcome measures
Feasibility - Study Enrollment
Time frame: From screening to randomization allocation
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.
Feasibility - Study Retention at 12 Weeks
Time frame: From baseline assessment to 12 weeks
Study retention will be measured by comparing observed rates of 12-week assessment completion to pre-specified benchmarks.
Feasibility - Study Retention at 24 Weeks
Time frame: From baseline assessment to 24 weeks
Study retention will be measured by comparing observed rates of 24-week assessment completion to pre-specified benchmarks.
Feasibility - Sustained Eligibility (Delayed Treatment Control Arm Only)
Time frame: From baseline to 12-week assessment
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.
Acceptability - Intervention
Time frame: From baseline to 12-week assessment in the Immediate Intervention arm; from 12-week assessment to 24-week assessment in the Delayed Treatment Control arm
The acceptability of the intervention will be measured by comparing rates of intervention completion to pre-determined thresholds.
Acceptability - Intervention
Time frame: From baseline to 12-week assessment in the Immediate Intervention arm; from 12-week assessment to 24-week assessment in the Delayed Treatment Control arm
The acceptability of the intervention will be measured by comparing participant Acceptability Intervention Measure (AIM) scores to pre-determined thresholds. The AIM is a 4-item questionnaire that measures participant perception that a given treatment is agreeable, palatable, or satisfactory. Items are rated on a Likert scale from 1=Completely Agree to 5=Completely Disagree.
Acceptability - Trial Procedures
Time frame: Week 24
The acceptability of the trial procedures will be measured by comparing rates of participant satisfaction with randomization methodology and assessment procedures to pre-determined thresholds. The satisfaction measure consists of 4 Likert-scale items and 2 Yes/No items encompassing perceptions of satisfaction regarding randomization, intervention schedule, questionnaire burden, and honorarium.
Appropriateness - Interventionist Report
Time frame: At 12-week assessment in the Immediate Intervention arm; at 24-week assessment in the Delayed Treatment Control arm
Intervention appropriateness will be assessed by the study interventionists for each participant using the Intervention Appropriateness Measure (IAM). The IAM will be completed following each session; average score will be used for outcome analyses. The IAM is a 4-item standardized scale that measures the perceived fit, relevance, or compatibility of the intervention for a given practice setting, provider, or consumer, and/or perceived fit of the intervention to address a particular issue or problem. Items are rated on a Likert scale from 1=Completely Agree to 5=Completely Disagree.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- \>/= 18 years of age at the time of enrollment Caregivers:
- nonprofessional caregiver to a patient with a primary malignant brain tumor (grade II-IV)
- Elevated Fear of Recurrence Distress Rating
- Primarily English speaking
- \>/= 18 years of age at the time of enrollment
Exclusion criteria
- Patient / Caregiver Exclusion:
- 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
Where
- Richmond, Virginia
Collaborators
National Cancer Institute (NCI), National Brain Tumor Society
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2025 · Source of record for eligibility and locations