Patel Manali I, Banks Lakedia, Das Millie
Division of Oncology, Stanford University School of Medicine, Stanford, CA, United States.
Medical Services, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, United States.
Contemp Clin Trials Commun. 2022 May 27;28:100929. doi: 10.1016/j.conctc.2022.100929. eCollection 2022 Aug.
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.
退伍军人的肺癌发病率和死亡率高于平民。肺癌退伍军人常常因复杂的合并症、有限的社会支持以及不愿与肿瘤医生讨论症状而症状治疗不足。有证据支持对患癌平民进行主动症状筛查；然而，迄今为止尚无研究评估退伍军人志愿者主导的主动症状筛查在肺癌退伍军人中是否可行且有效。“改善胸部恶性肿瘤患者的支持性护理”研究是由一个预先成立的退伍军人及家属咨询委员会共同开展的。肺癌退伍军人按1:1比例随机分配至接受为期9个月的干预并结合常规肿瘤护理的组（干预组）或仅接受常规肿瘤护理的组（对照组）。为干预组的所有退伍军人分配一名退伍军人志愿者，该志愿者使用经过验证的症状调查问卷进行每周症状评估，并与一名肿瘤学执业护士一起审查所有症状评分。主要结局是评估与对照组相比，干预措施是否能改善干预组退伍军人入组后6个月时症状的记录情况。次要结局包括患者报告结局的变化（即症状负担、患者能动性、患者对决策的满意度、健康相关生活质量）以及从基线（研究入组时间）到入组后3个月、6个月和9个月急性护理使用情况的差异（即急诊就诊、住院情况）。这项研究解决了退伍军人及其护理人员表达的一个重大关切。研究结果可增进我们对如何改善肺癌退伍军人症状负担的理解。ClinicalTrials.gov注册号：#NCT03216109
