Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
112 participants
INTERVENTIONAL
2025-06-24
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Fearless Immediate Treatment Arm
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.
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.
FearLess Delayed Control Arm
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Brain Tumor Society
UNKNOWN
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Ashlee R Loughan, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Sarah E Braun, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HM20031650
Identifier Type: OTHER
Identifier Source: secondary_id
MCC-24-21975
Identifier Type: -
Identifier Source: org_study_id
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