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Recruiting NCT06989086

FearLess in NeuroOncology

No phase Interventional Primary Malignant Brain Tumor Glioblastoma (GBM) Astrocytoma Oligodendroglioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fearless in Neuro-Oncology.
Who it may be relevant to
Registry conditions: Primary Malignant Brain Tumor, Glioblastoma (GBM), Astrocytoma, Oligodendroglioma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

FearLess in Neuro-Oncology

Overview

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.

Interventions

  • Behavioral Fearless 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.

Primary outcome measures

  • Feasibility - Study Enrollment [Time frame: From screening to randomization allocation]
  • Feasibility - Study Retention at 12 Weeks [Time frame: From baseline assessment to 12 weeks]
  • Feasibility - Study Retention at 24 Weeks [Time frame: From baseline assessment to 24 weeks]
  • Feasibility - Sustained Eligibility (Delayed Treatment Control Arm Only) [Time frame: From baseline to 12-week assessment]
  • 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]
  • 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]
  • Acceptability - Trial Procedures [Time frame: Week 24]
  • Appropriateness - Interventionist Report [Time frame: At 12-week assessment in the Immediate Intervention arm; at 24-week assessment in the Delayed Treatment Control arm]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT06989086 · MCC-24-21975 · 1R34CA286879 · HM20031650

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗