FearLess for adults with malignant brain tumors and their caregivers
Official title: FearLess in Neuro-Oncology
Run by Virginia Commonwealth University · NCT06989086 · Data updated 2026-11-12
This project will test whether the FearLess psychological program can reduce fear of cancer recurrence in adults with primary malignant brain tumors and their nonprofessional caregivers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 112 (estimated) |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Status | Recruiting |
| Started | June 24, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT06989086 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with a self-reported primary malignant brain tumor (grade II-IV) more than two weeks after cranial resection/biopsy, or their nonprofessional caregivers, who report elevated fear of recurrence, speak English, can consent, and can attend virtual sessions.
✕Probably not a fit
People with cognitive impairment preventing active engagement, those who cannot provide informed consent, or those without a reliable internet connection for virtual sessions are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized feasibility trial will enroll 112 adults with primary malignant brain tumors (grade II-IV) and their caregivers to test recruitment methods, the target population, and a waitlist control design for the FearLess intervention. Participants are randomized to immediate intervention or delayed treatment (waitlist) and complete assessments at baseline, Week 12, and Week 26. The study will measure feasibility, acceptability, and appropriateness of the procedures to finalize the intervention protocol. Sessions require the ability to participate virtually and exclude people with cognitive impairment that prevents engagement.
Why it matters
Potential benefit: If successful, the program could reduce fear of cancer recurrence and improve coping and quality of life for patients and caregivers.
How similar studies have gone: Related cognitive-behavioral and psychosocial interventions have reduced fear of cancer recurrence in other cancer populations, but neuro-oncology-specific evidence is limited, so this approach is partly evidence-based but not well tested in brain tumor patients.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Virginia Commonwealth University
Richmond, Virginia, United States Recruiting
Study contacts
- Principal investigator: Ashlee R Loughan, Ph.D — Virginia Commonwealth University
- Study coordinator: Mary Bridgman
- Email: LiveNOW@vcu.edu
- Phone: 804-628-6799
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.