FearLess in NeuroOncology

Virginia Commonwealth University (VCU)

Status: Enrolling

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

Treatments: Behavioral: Fearless in Neuro-Oncology

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06989086

HM20031650 (Other Identifier)

MCC-24-21975

1R34CA286879 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Fearless Immediate Treatment Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Fearless in Neuro-Oncology

FearLess Delayed Control Arm

Other group

Description:

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.

Treatment:

Behavioral: Fearless in Neuro-Oncology