Investigating Feasibility and Acceptability of the FearLess Protocol for Patients with Primary Malignant Brain Tumors and Their Caregivers

PROJECT SUMMARY / ABSTRACT Fear of cancer recurrence (FCR) is alarmingly high among patients with primary malignant brain tumors, who face the certainty of tumor recurrence given the current insufficient curative treatment options and who will experience a resultant lifetime of oncological and neurological sequelae. Moderate-to-severe levels of FCR can

have dire consequences for cancer patients, such as impeding daily function, activating maladaptive coping patterns, and reducing medical treatment adherence. FCR also plays a significant role in the lives of family members—our work shows rates of FCR among brain tumor caregivers are higher than the patients themselves.

Despite this, existing psychological interventions targeting FCR are not translatable to neuro-oncology and contain discriminatory inclusion criteria prohibiting our brain tumor patients and caregivers from participation. In response to this historic inequity and the vital need, our team developed FearLess: a novel, evidence-informed,

mindfulness-based, cognitive-existential, manualized psychological intervention targeting FCR in neuro- oncology populations. However, study feasibility and acceptability issues remain. We identified three information gaps specific to recruitment methodology, study population suitability, and control group feasibility in need of

resolution prior to FearLess protocol finalization and intervention implementation in larger-scale trials. First, to identify ideal recruitment methods, we need to evaluate the feasibility of a cohesive multimodal national recruitment strategy for both neuro-oncology patients (n=40) and caregivers (n=40). Second, to refine the

appropriate study population, we need to examine the feasibility and acceptability of the FearLess intervention and associated study procedures across stratification groups (recurrent status and participant role). Lastly, to investigate the appropriateness of a control group, we need to assess the feasibility and acceptability of a

randomized waitlist-control in both patients and caregivers. As such, the proposed study is a Phase IIb randomized waitlist-controlled trial, per the NIH ORBIT Model, assessing the feasibility and acceptability of recruitment strategies, target population, and appropriateness of a waitlist control group in order to

finalize the protocol of FearLess for primary malignant brain tumor patients and caregivers. Eighty participants will be randomized to either immediate intervention or waitlist control. Randomization will be stratified by recurrence status (newly diagnosed or recurrent) and participant role (patient or caregiver). Recruitment

strategy will be evaluated by outlet yield and cost. We will assess feasibility and acceptability metrics throughout enrollment, intervention, and follow-up periods including screening completion rate, eligibility rate, enrollment rate, intervention adherence, intervention satisfaction, as well as retention, and evaluate whether these metrics

differ between multifactorial stratification groups (newly diagnosed v. recurrent; patients v. caregivers). Given the underrepresentation of neuro-oncology in FCR studies, this study will yield critical knowledge prior to finalizing the FearLess protocol for larger-scale trials.