Recruiting

Observational Study

Sponsor:

Virginia Commonwealth University

Code:

NCT06989086

Conditions

Primary Malignant Brain Tumor

Glioblastoma (GBM)

Astrocytoma

Oligodendroglioma

Caregiver

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fearless in Neuro-Oncology

Study Details

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

Study ID

NCT06989086

Start date

Jun 24, 2025

Status verified date

Sep, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

112 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

other: 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.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Mary Bridgman

804-628-6799LiveNOW@vcu.edu

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Ashlee Loughan, PhD

ashlee.loughan@vcuhealth.org

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • brain tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-09-09.