FearLess in NeuroOncology

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: FearLess in Neuro-Oncology

Conditions

Primary Malignant Brain Tumor, Glioblastoma (GBM), Astrocytoma, Oligodendroglioma, Caregiver

Being tested

Fearless in Neuro-Oncology

Keywords

brain tumor

Medical subject headings

Glioblastoma, Astrocytoma, Oligodendroglioma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Fearless in Neuro-OncologyBehavioural

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: From screening to randomization allocation

2. Feasibility - Study Retention at 12 Weeks

   Study retention will be measured by comparing observed rates of 12-week assessment completion to pre-specified benchmarks.

   Measured: From baseline assessment to 12 weeks

3. Feasibility - Study Retention at 24 Weeks

   Study retention will be measured by comparing observed rates of 24-week assessment completion to pre-specified benchmarks.

   Measured: From baseline assessment to 24 weeks

4. 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.

   Measured: From baseline to 12-week assessment

5. Acceptability - Intervention

   The acceptability of the intervention will be measured by comparing rates of intervention completion to pre-determined thresholds.

   Measured: 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

6. 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.

   Measured: 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

7. 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.

   Measured: Week 24

8. 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.

   Measured: At 12-week assessment in the Immediate Intervention arm; at 24-week assessment in the Delayed Treatment Control arm

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted25 May 2025
2. Study start24 Jun 2025
3. Primary completion31 Dec 2028 (estimated)
4. Study completion31 Dec 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Primary Malignant Brain TumorStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.