Actively Recruiting
FearLess in Neuro-Oncology: A Psychological Intervention Trial for Primary Malignant Brain Tumor Patients and Caregivers
Led by Virginia Commonwealth University · Updated on 2025-09-09
112
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility, acceptability, and appropriateness of recruitment methods, target population, and a waitlist design for FearLess, a psychological intervention aimed at reducing fear of cancer recurrence in patients with primary malignant brain tumors and their caregivers. The study focuses on patients with diagnoses such as glioblastoma, astrocytoma, and oligodendroglioma, as well as their caregivers. This project seeks to finalize the protocol of the FearLess intervention through a randomized design. Participants will be randomly assigned to one of two groups: an immediate treatment group receiving the FearLess intervention right after enrollment, or a delayed treatment control group starting the intervention after a 12-week no-treatment period. FearLess consists of an intake session plus eight weekly individual virtual therapy sessions lasting 60 to 90 minutes over 12 weeks. Assessments will be conducted at baseline, 12 weeks, and 26 weeks to evaluate the intervention and trial procedures. Throughout the trial, participants will complete questionnaires and assessments related to feasibility, acceptability, and appropriateness at multiple time points. The research team will monitor enrollment, retention, and sustained eligibility, especially in the delayed group. Participants will engage in virtual therapy sessions and complete follow-up assessments over approximately 26 weeks, allowing researchers to gather data on intervention engagement and outcomes under a waitlist study design.
CONDITIONS
Brief Title
FearLess in NeuroOncology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-report a diagnosis of a primary malignant brain tumor (grade II-IV)
- More than 2 weeks post-cranial resection or biopsy
- Elevated fear of recurrence distress rating
- Primarily English speaking
- At least 18 years of age at the time of enrollment
- Nonprofessional caregiver to a patient with a primary malignant brain tumor (grade II-IV)
- Elevated fear of recurrence distress rating (caregivers)
- Primarily English speaking (caregivers)
- At least 18 years of age at the time of enrollment (caregivers)
You will not qualify if you...
- Cognitive impairment that might prevent active engagement in the intervention
- Inability to understand and provide informed consent
- Inability to attend virtual sessions due to unstable or no internet connection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (virtual) for eligibility assessment
Duration - 12 weeks
Participants undergo a psychological intervention consisting of an intake and 8 weekly individual virtual therapy sessions over a 12-week period.
Weekly virtual sessions for 12 weeks
Duration - 12 weeks
Participants in the delayed treatment arm begin the same psychological intervention after a 12-week no-treatment period.
Weekly virtual sessions for 12 weeks
Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
M
Mary Bridgman
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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