FearLess for adults with malignant brain tumors and their caregivers
FearLess in Neuro-Oncology
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06989086 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Richmond, Virginia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.