RecruitingInterventional

FearLess in Neuro-Oncology

NCT ID: NCT06989086Sponsor: Virginia Commonwealth UniversityLast updated: 2025-09-09

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.

Arms & interventions

BehavioralFearless 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.

Outcome measures

Primary

Feasibility - Study Enrollment
Feasibility of study enrollment using a multimodal recruitment approach will be assessed by comparing observed rates of screening completion, trial eligibility, trial enrollment (i.e., informed consent), and randomization allocation to pre-specified benchmarks.
Time frame: From screening to randomization allocation
Feasibility - Study Retention at 12 Weeks
Study retention will be measured by comparing observed rates of 12-week assessment completion to pre-specified benchmarks.
Time frame: From baseline assessment to 12 weeks
Feasibility - Study Retention at 24 Weeks
Study retention will be measured by comparing observed rates of 24-week assessment completion to pre-specified benchmarks.
Time frame: From baseline assessment to 24 weeks
Feasibility - Sustained Eligibility (Delayed Treatment Control Arm Only)
Feasibility of sustained trial eligibility will be assessed in the delayed treatment control arm only by comparing the proportion of participants who remain eligible at 12 weeks to a pre-determined threshold.
Time frame: From baseline to 12-week assessment
Acceptability - Intervention
The acceptability of the intervention will be measured by comparing rates of intervention completion to pre-determined thresholds.
Time frame: 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
Acceptability - Intervention
The acceptability of the intervention will be measured by comparing participant Acceptability Intervention Measure (AIM) scores to pre-determined thresholds. The AIM is a 4-item questionnaire that measures participant perception that a given treatment is agreeable, palatable, or satisfactory. Items are rated on a Likert scale from 1=Completely Agree to 5=Completely Disagree.
Time frame: 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
Acceptability - Trial Procedures
The acceptability of the trial procedures will be measured by comparing rates of participant satisfaction with randomization methodology and assessment procedures to pre-determined thresholds. The satisfaction measure consists of 4 Likert-scale items and 2 Yes/No items encompassing perceptions of satisfaction regarding randomization, intervention schedule, questionnaire burden, and honorarium.
Time frame: Week 24
Appropriateness - Interventionist Report
Intervention appropriateness will be assessed by the study interventionists for each participant using the Intervention Appropriateness Measure (IAM). The IAM will be completed following each session; average score will be used for outcome analyses. The IAM is a 4-item standardized scale that measures the perceived fit, relevance, or compatibility of the intervention for a given practice setting, provider, or consumer, and/or perceived fit of the intervention to address a particular issue or problem. Items are rated on a Likert scale from 1=Completely Agree to 5=Completely Disagree.
Time frame: At 12-week assessment in the Immediate Intervention arm; at 24-week assessment in the Delayed Treatment Control arm

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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

Study locations (1)

Virginia Commonwealth University

Richmond, Virginia, 23298

Recruiting

Ashlee Loughan, PhD · Contact

ashlee.loughan@vcuhealth.org