FearLess in NeuroOncology for Brain Tumor Patients and Caregivers
This study is testing a new psychological support program called FearLess in Neuro-Oncology. This program involves weekly virtual therapy sessions over 12 weeks. It's designed to help patients with primary malignant brain tumors (like glioblastoma, astrocytoma, or oligodendroglioma) and their caregivers manage fear of recurrence. To join, you must be at least 18 years old, speak English, and have a primary malignant brain tumor (or be a caregiver for someone who does). You also need to report elevated fear of recurrence distress. The main goal of this study is to see if it's practical to recruit people, if they stay in the study, and if the program is acceptable. The study is currently recruiting 112 participants.
- Study design
- This is an interventional study where 112 participants will be randomly assigned to either receive the FearLess intervention right away or after a delay.
- What's involved
- If you participate, you will have weekly individual 60- to 90-minute virtual therapy sessions for 12 weeks. You will also complete assessments at the beginning, at 12 weeks, and at 26 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 24 weeks after starting the study to assess retention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
FearLess in NeuroOncology
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ashlee R Loughan, Ph.D · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University
- Sarah E Braun, Ph.D. · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Feasibility - Study EnrollmentFrom screening to randomization allocation
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.
- Feasibility - Study Retention at 12 WeeksFrom baseline assessment to 12 weeks
Study retention will be measured by comparing observed rates of 12-week assessment completion to pre-specified benchmarks.
- Feasibility - Study Retention at 24 WeeksFrom baseline assessment to 24 weeks
Study retention will be measured by comparing observed rates of 24-week assessment completion to pre-specified benchmarks.
- Feasibility - Sustained Eligibility (Delayed Treatment Control Arm Only)From baseline to 12-week assessment
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.
- Acceptability - InterventionFrom baseline to 12-week assessment in the Immediate Intervention arm; from 12-week assessment to 24-week assessment in the Delayed Treatment Control arm
The acceptability of the intervention will be measured by comparing rates of intervention completion to pre-determined thresholds.
- Acceptability - InterventionFrom baseline to 12-week assessment in the Immediate Intervention arm; from 12-week assessment to 24-week assessment in the Delayed Treatment Control arm
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.
- Acceptability - Trial ProceduresWeek 24
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.
- Appropriateness - Interventionist ReportAt 12-week assessment in the Immediate Intervention arm; at 24-week assessment in the Delayed Treatment Control arm
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.