Clinical trial NCT06989086: FearLess in NeuroOncology
Official title: FearLess in Neuro-Oncology
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Primary Malignant Brain Tumor
Glioblastoma (GBM)
Astrocytoma
Oligodendroglioma
Caregiver
Keywords: brain tumor
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Brain Tumor Society
First posted: 2025-05-25
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Malignant primary brain tumor patients Malignant primary brain tumor caregivers Malignant Primary Brain Tumor Dyads (patients \& caregivers) All with elevated levels of fear of cancer recurrence

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

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: 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

Primary outcomes:
measure: Feasibility - Study Enrollment
timeFrame: From screening to randomization allocation
measure: Feasibility - Study Retention at 12 Weeks
timeFrame: From baseline assessment to 12 weeks
measure: Feasibility - Study Retention at 24 Weeks
timeFrame: From baseline assessment to 24 weeks
measure: Feasibility - Sustained Eligibility (Delayed Treatment Control Arm Only)
timeFrame: From baseline to 12-week assessment
measure: Acceptability - Intervention
timeFrame: From baseline to 12-week assessment in the Immediate Intervention arm; from 12-week assessment to 24-week assessment in the Delayed Treatment Control arm
measure: Acceptability - Intervention
timeFrame: From baseline to 12-week assessment in the Immediate Intervention arm; from 12-week assessment to 24-week assessment in the Delayed Treatment Control arm
measure: Acceptability - Trial Procedures
timeFrame: Week 24
measure: Appropriateness - Interventionist Report
timeFrame: At 12-week assessment in the Immediate Intervention arm; at 24-week assessment in the Delayed Treatment Control arm
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ashlee R Loughan, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Sarah E Braun, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: