Evaluating the FearLess Psychological Intervention for Adults with Primary Malignant Brain Tumors and Their Caregivers

What this Trial Is About

Researchers are evaluating the feasibility, acceptability, and appropriateness of recruitment methods, target population, and a waitlist design for FearLess, a psychological intervention aimed at reducing fear of cancer recurrence in patients with primary malignant brain tumors and their caregivers. The study focuses on patients with diagnoses such as glioblastoma, astrocytoma, and oligodendroglioma, as well as their caregivers. This project seeks to finalize the protocol of the FearLess intervention through a randomized design. Participants will be randomly assigned to one of two groups an immediate treatment group receiving the FearLess intervention right after enrollment, or a delayed treatment control group starting the intervention after a 12-week no-treatment period. FearLess consists of an intake session plus eight weekly individual virtual therapy sessions lasting 60 to 90 minutes over 12 weeks. Assessments will be conducted at baseline, 12 weeks, and 26 weeks to evaluate the intervention and trial procedures. Throughout the trial, participants will complete questionnaires and assessments related to feasibility, acceptability, and appropriateness at multiple time points. The research team will monitor enrollment, retention, and sustained eligibility, especially in the delayed group. Participants will engage in virtual therapy sessions and complete follow-up assessments over approximately 26 weeks, allowing researchers to gather data on intervention engagement and outcomes under a waitlist study design.

FearLess in NeuroOncology