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NCT06989086 | RECRUITING | Primary Malignant Brain Tumor

FearLess in NeuroOncology
Sponsor:

Virginia Commonwealth University

Brief 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

Condition or disease

Primary Malignant Brain Tumor

Glioblastoma (GBM)

Astrocytoma

Oligodendrogliooma

Caregiver

Intervention/treatment

Fearless in Neuro-Oncology

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 112 participants
Official Title : FearLess in Neuro-Oncology
Actual Study Start Date : 2025-06-18
Estimated Primary Completion Date : 2028-12-31
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
FearLess in NeuroOncology

Location Details

NCT06989086

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23298