NCT06989086

FearLess in NeuroOncology

FearLess in Neuro-Oncology

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Malignant Brain Tumor
• Glioblastoma (GBM)
• Astrocytoma
• Oligodendroglioma
• Caregiver

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-24
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-05-25
• Last updated: 2025-09-09

Locations

1 site across 1 country: United States