FearLess in NeuroOncology

NCT06989086 | Recruiting

• 3 other identifiers: MCC-24-219751R34CA286879HM20031650
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

brain tumor

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

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

Study Arms (2)

Fearless Immediate Treatment Arm

EXPERIMENTAL

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. FearLess will be delivered immediately following enrollment in this arm.

Behavioral: Fearless in Neuro-Oncology

FearLess Delayed Control Arm

OTHER

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. In this arm, the FearLess intervention will begin following a 12-week no-treatment period.

Behavioral: Fearless in Neuro-Oncology

Interventions

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.

FearLess Delayed Control Arm; Fearless Immediate Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator
• National Brain Tumor Society: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Astrocytoma; Oligodendroglioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ashlee R Loughan, Ph.D

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Sarah E Braun, Ph.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Bridgman

CONTACT

804-628-6799; LiveNOW@vcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Delayed treatment control design

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 25, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)