Background: Family caregivers of patients with high-grade gliomas experience unique challenges often related to patients’ neurocognitive deficits and sudden performance declines. Evidence-based caregiving skill training programs to support caregivers in their caregiving role are currently lacking. The primary aim of this research protocol is to determine the feasibility of implementing a simulation-based training intervention for family caregivers of patients with high-grade gliomas using a randomized controlled trial design.

Method: Fifty patients with a high-grade glioma and their family caregivers will be randomized to the caregiving intervention or a waitlist control group. The 4-session intervention content includes two nurse-led simulation-based caregiving skills sessions and two nurse-led psychoeducation sessions offering further education and emotional support around role changes. Prior to randomization, dyads will complete self-report assessments at baseline and again 12 and 16 weeks later. Patient healthcare utilization will be extracted from the electronic medical records. Feasibility will be determined by four criteria: overall accrual, attrition, adherence, and acceptability. We will judge this trial as feasible if: 1) ≥ 50% of approached dyads consent; 2) ≥ 70% of enrolled dyads complete all assessments; and for the intervention group, 3) on average, ≥ 50% of sessions are attended; and 4) ≥ 80% of all caregivers rate the sessions as “helpful” on program evaluations. We will examine means, standard deviations (SDs), and distributions of measures for patient and caregiver psychological symptoms, caregiving-related outcomes, and patient cancer-related symptom and healthcare utilization. Using a qualitative approach, we will explore the caregiver experience with the study and with caring for an individual with a high-grade glioma to inform future research.
Results: To date, we have approached 95 dyads and enrolled 38 dyads (consent rate 40%) in this ongoing trial. We anticipate completion of enrollment in January 2025. We will present feasibility data as well as trends in outcomes including patient and caregiver psychological symptoms, caregiver caregiving self-efficacy and role adjustment, and patient cancer-related symptoms at baseline and 6-week post-intervention.

Conclusions: This trial will provide important information regarding the feasibility of delivering simulation-based skills training and if a larger efficacy trial is warranted.