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NCT Number: NCT06989086

FearLess in NeuroOncology

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

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Key information

Conditions

Primary Malignant Brain Tumor Astrocytoma Brain Diseases Brain Neoplasms Caregiver Central Nervous System Diseases Central Nervous System Neoplasms Glioblastoma Glioblastoma (GBM) Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Oligodendroglioma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location status: Recruiting

Location contact

Ashlee Loughan, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fearless in Neuro-Oncology

Behavioral

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.

Primary outcomes

  1. Feasibility - Study Enrollment

    Time frame: From 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.

  2. Feasibility - Study Retention at 12 Weeks

    Time frame: From baseline assessment to 12 weeks

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

  3. Feasibility - Study Retention at 24 Weeks

    Time frame: From baseline assessment to 24 weeks

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

  4. Feasibility - Sustained Eligibility (Delayed Treatment Control Arm Only)

    Time frame: 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.

  5. Acceptability - Intervention

    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

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

  6. Acceptability - Intervention

    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

    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.

  7. Acceptability - Trial Procedures

    Time frame: Week 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.

  8. Appropriateness - Interventionist Report

    Time frame: At 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Bridgman

CONTACT

[email protected]

804-628-6799

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Brain Tumor Society
  • National Cancer Institute (NCI)

Registry information

Official study title

FearLess in Neuro-Oncology

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 25, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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