RecruitingRecruiting
FearLess in NeuroOncology
NCT06989086 · Virginia Commonwealth University
In plain English
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Official title
FearLess in Neuro-Oncology
About this study
The purpose of this study is to assess the feasibility, acceptability, appropriateness (FAA) of recruitment methods, study population, and waitlist design to finalize the protocol of FearLess, a psychological intervention targeting fear of cancer recurrence in primary malignant brain tumor patients and caregivers. Eligible participants (N=112) will be randomized to either: 1) immediate intervention or 2) delayed treatment control. Assessments will take place at baseline, Week 12, and Week 26.
Eligibility criteria
Inclusion Criteria:
Patients:
* 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
Study design
Enrollment target: 112 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-06-24
Estimated completion: 2028-12-31
Last updated: 2026-09-09
Interventions
Behavioral: Fearless in Neuro-Oncology
Primary outcomes
- • Feasibility - Study Enrollment (From screening to randomization allocation)
- • Feasibility - Study Retention at 12 Weeks (From baseline assessment to 12 weeks)
- • Feasibility - Study Retention at 24 Weeks (From baseline assessment to 24 weeks)
Sponsor
Virginia Commonwealth University · other
With: National Cancer Institute (NCI), National Brain Tumor Society
Contacts & investigators
ContactMary Bridgman · contact · LiveNOW@vcu.edu · 804-628-6799
InvestigatorAshlee R Loughan, Ph.D · principal_investigator, Virginia Commonwealth University
InvestigatorSarah E Braun, Ph.D. · principal_investigator, Virginia Commonwealth University
All locations (1)
Virginia Commonwealth UniversityRecruiting
Richmond, Virginia, United States