Factors associated with psychological distress in caregivers of patients with malignant gliomas.

PURPOSE: Caregivers of patients with malignant gliomas are at risk for psychological distress. However, factors associated with distress in this population have not been well described. We conducted a prospective study evaluating psychological distress in patients with malignant gliomas and their caregivers and exploring factors associated with caregiver distress. METHODS: We enrolled patients with newly diagnosed malignant gliomas (N = 77) and their caregivers (N = 61). At baseline and 3, 6, and 9 months after diagnosis, we administered the Hospital Anxiety and Depression Scale to assess psychological distress and the Caregiver Reaction Assessment to evaluate caregiver burden. We performed multivariable regression analyses to investigate caregiver-related, patient-related, and tumor-related factors associated with caregivers' distress. RESULTS: At baseline, 48.3% (29/60) and 26.2% (16/61) of caregivers reported clinically significant anxiety and depression symptoms, respectively. Anxiety and depression symptoms persisted over time. Greater caregiver depression was associated with male gender (B = 1.48, 95% CI 0.16-2.81, p = 0.03), higher caregiver burden (B = 0.08, 95% CI 0.01-0.15, p = 0.02), caregiver anxiety (B = 0.53, 95% CI 0.38-0.68, p < 0.0001), patient depression (B = 0.34, 95% CI 0.13-0.55, p = 0.002), and caring for a younger patient (B = -0.07, 95% CI -0.15 to 0.00, p = 0.049). Factors associated with greater caregiver anxiety symptoms were caregiver depression (B = 0.91, 95% CI 0.71-1.12, p < 0.0001) and younger patient age (B = -0.15, 95% CI -0.24 to -0.05, p = 0.003). CONCLUSION: Male gender, higher caregiver burden, greater patient depression symptoms, and younger patient age are associated with increased distress among caregivers of patients with malignant gliomas, underscoring the need for tailored supportive care interventions targeting caregivers at highest risk for psychological distress.

NeuroCARE: A Randomized Controlled Trial of a Psychological Intervention for Caregivers of Patients With Primary Malignant Brain Tumors.

PURPOSE: Caregivers of patients with primary malignant brain tumors (PMBT) experience significant psychological distress. We assessed the effect of a psychological intervention (NeuroCARE) on anxiety symptoms among PMBT caregivers. METHODS: We conducted a randomized trial of NeuroCARE versus usual care in PMBT caregivers with elevated anxiety (Generalized Anxiety Disorder-7 score ≥5) within 6 months of the patient's diagnosis. NeuroCARE was developed for PMBT caregivers and consists of six telehealth sessions with a behavioral health specialist. Participants completed surveys at baseline, 11-week (postintervention), and 16-week (1-month postintervention) time points. The primary outcome was 11-week anxiety symptoms (Hospital Anxiety and Depression Scale [HADS]-Anxiety Subscale). We also measured depression symptoms (HADS-Depression Subscale), quality of life (QOL; Caregiver QOL survey), caregiver burden (Caregiver Reaction Assessment), self-efficacy (Lewis Cancer Self-Efficacy Scale), coping (Measure of Current Status), and post-traumatic stress disorder (PTSD) symptoms (PTSD Checklist for DSM-5). We conducted analysis of covariance and linear mixed-effects regression analyses to examine intervention effects on study outcomes. RESULTS: We enrolled 120 caregivers (60/group) between October 2019 and June 2022; 105 were evaluable for the primary outcome. At 11 weeks, NeuroCARE participants reported significantly lower anxiety symptoms than usual care participants (M, 8.87 v 10.69; P = .008). NeuroCARE caregivers also reported significantly lower depression symptoms (M, 6.08 v 7.77; P = .004), and better self-efficacy (M, 128.81 v 111.17; P < .001) and coping (M, 32.25 v 25.65; P < .001) at 11 weeks. Study groups did not differ significantly in 11-week QOL, caregiver burden, or PTSD symptoms. In longitudinal analyses, intervention effects on depression symptoms, self-efficacy, and coping were sustained. CONCLUSION: A novel, population-specific psychological intervention led to improved anxiety and depression symptoms, self-efficacy, and coping among PMBT caregivers.

Study protocol for NeuroCARE: a randomised controlled trial of a psychological intervention for caregivers of patients with primary malignant brain tumours.

INTRODUCTION: Caregivers of patients with primary malignant brain tumours experience substantial psychological distress while caring for someone with a progressive, life-limiting neurological illness. However, there are few interventions aimed at addressing the psychosocial needs of this population. We developed and are testing a population-specific, evidence-based, telehealth intervention (NeuroCARE) to reduce anxiety symptoms and improve psychosocial functioning in this caregiver population. METHODS AND ANALYSIS: This study is a non-blinded, randomised controlled trial of a psychological intervention for caregivers of patients with primary malignant brain tumours receiving care at the Massachusetts General Hospital Cancer Center or Dana-Farber Cancer Institute. We will enrol 120 caregivers who screen positive for heightened anxiety. Participants will be randomised 1:1 to the NeuroCARE intervention or a usual care control condition. Caregivers assigned to NeuroCARE will complete six individual telehealth sessions with a trained behavioural health specialist over 12 weeks. Caregivers randomised to the control condition will receive usual care, including possible referral to social work or other appropriate resources. Participants will complete self-report questionnaires at baseline and 11 weeks and 16 weeks postrandomisation. The primary outcome is anxiety symptoms at 11 weeks among NeuroCARE participants, compared with usual care. Secondary outcomes include caregiver-reported depressive symptoms, quality of life, caregiver burden, caregiving self-efficacy, perceived coping skills and post-traumatic stress disorder symptoms. We also will explore potential mediators of the NeuroCARE effect on caregiver anxiety symptoms. ETHICS AND DISSEMINATION: The study is funded by a Career Development Award from Conquer Cancer, the American Society of Clinical Oncology Foundation (award number 2019CDA-7743456038) and approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board (Protocol #19-250 V.10.1). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. Results will be presented at scientific meetings and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04109209.