Improving supportive care for patients with Thoracic Malignancies - A randomized controlled trial

改善胸部恶性肿瘤患者的支持治疗——一项随机对照试验

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Abstract

Veterans have higher lung cancer incidence and mortality rates than civilians. Frequently, Veterans with lung cancer suffer from undertreated symptoms due to complex comorbidities, limited social support, and reluctance in discussing symptoms with their oncologists. Evidence supports proactive symptom screening among civilians with cancer; however, no studies to date have evaluated whether Veteran volunteer-led proactive symptom screening is feasible and effective among Veterans with lung cancer. The "Improving Supportive Care for Patients with Thoracic Malignancies" study was co-developed by a pre-established Veteran and Family Advisory Board. Veterans with lung cancer are randomized in a 1:1 allocation to either a 9-month intervention combined with usual oncology care (intervention group) or usual oncology care alone (control group). A Veteran volunteer is assigned to all Veterans in the intervention group and conducts weekly symptom assessments using validated symptom surveys and reviews all symptom scores with an oncology nurse practitioner. The primary outcome is to evaluate whether the intervention improves documentation of symptoms at 6 months post-enrollment among Veterans in the intervention group as compared with the control group. Secondary outcomes include changes in patient-reported outcomes (i.e., symptom burden, patient activation, patient satisfaction with decision, health-related quality of life) and differences in acute care use (i.e., emergency department visits, hospitalizations) from baseline (time of enrollment in the study) to 3-, 6-, and 9-months post enrollment. This study addresses a significant concern expressed by Veterans and their caregivers. Findings can advance our understanding of how to improve symptom-burden among Veterans with lung cancer. ClinicalTrials.gov Registration #NCT03216109.

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