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NCT06989086NARecruiting

FearLess in NeuroOncology

Virginia Commonwealth University

Start Date

6/24/2025

Completion Date

12/31/2028

Summary

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

Detailed Description

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

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

Fearless in Neuro-Oncology

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Conditions

Primary Malignant Brain TumorGlioblastoma (GBM)AstrocytomaOligodendrogliomaCaregiver

Locations

Virginia Commonwealth University

Richmond, Virginia 23298

United States