FearLess in NeuroOncology

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06989086
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Virginia Commonwealth University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ashlee R Loughan, Ph.DSarah E Braun, Ph.D.
Principal Investigator Affiliation Virginia Commonwealth UniversityVirginia Commonwealth University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Primary Malignant Brain Tumor, Glioblastoma (GBM), Astrocytoma, Oligodendroglioma, Caregiver
Additional Details

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.

Arms & Interventions

Arms

: 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 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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Virginia Commonwealth University, Richmond, Virginia

Status

Recruiting

Address

Virginia Commonwealth University

Richmond, Virginia, 23298

Site Contact

Ashlee Loughan, PhD

[email protected]

804-628-6799

Stay Informed & Connected