Missel Malene, Langballe Rikke, Quist Morten, Donsel Pernille Orloff, Bidstrup Pernille E, Huang Lin, Borregaard Britt, Stenger Michael, Andersen Pernille Brasch, Christensen Thomas Decker, Corvinius Camilla, Moons Johnny, Fehlmann Florian, Saghir Zaigham, Dai Wei, Hansen Lisbeth Søbæk, Petersen Rene Horsleben, Schoenau Mai Nanna
Department of Cardiothoracic Surgery, Copenhagen University Hospital, Copenhagen, Denmark
University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.
BMJ Open. 2025 Apr 23;15(4):e094823. doi: 10.1136/bmjopen-2024-094823.
Despite global advances in lung cancer treatment, challenges persist in symptom management and supportive care, particularly as the incidence of early-stage diagnoses rises. Patients with non-small cell lung cancer (NSCLC) face symptom burdens compounded by physical, psychological and social factors, alongside the concealment of early-stage symptoms. Research on symptom management in patients with NSCLC remains limited, with a lack of studies exploring patient experiences and clinical management strategies. Moreover, attention to late effects highlights the need for personalised care interventions to address long-term outcomes. The SCAPAS-LungCancer study aims to bridge these gaps by enhancing our understanding of NSCLC symptomatology, late effects and quality of life. The study seeks to identify patients with multiple symptoms and late effects, offering insights for future personalised care interventions to improve patient outcomes and overall well-being.
The study employs a multiple-methods approach encompassing qualitative and quantitative investigations to comprehensively explore symptomatology, patient experiences and treatment outcomes in patients with NSCLC undergoing surgical treatment. A prospective, longitudinal, observational and exploratory design is adopted. A longitudinal qualitative study, including individual interviews and ethnographic fieldwork, will be conducted to explore patients' experiences and interactions with clinicians on symptoms and late effects. Additionally, consecutive newly diagnosed patients with NSCLC scheduled for surgery will be recruited in a prospective questionnaire study using patient-reported outcomes. Eligible patients will complete self-reported measures assessing physical and psychosocial symptom burden and late effects, quality of life, social support and unmet needs at baseline and multiple follow-up points post-surgery over a 2-year period. Socio-demographic and medical characteristics are also collected.
The study is approved by the Danish Data Protection Agency (journal no: 2022-737) and conducted in accordance with Danish Ethics Research Committee guidelines and the Helsinki II Declaration. Participants will provide written informed consent. The results will be reported in peer-reviewed journals.
尽管全球肺癌治疗取得了进展，但在症状管理和支持性护理方面仍存在挑战，尤其是随着早期诊断发病率的上升。非小细胞肺癌（NSCLC）患者面临着身体、心理和社会因素叠加的症状负担，同时早期症状还具有隐匿性。关于NSCLC患者症状管理的研究仍然有限，缺乏探索患者体验和临床管理策略的研究。此外，对晚期影响的关注凸显了采取个性化护理干预措施以解决长期预后问题的必要性。SCAPAS - 肺癌研究旨在通过增进我们对NSCLC症状学、晚期影响和生活质量的理解来弥合这些差距。该研究旨在识别有多种症状和晚期影响的患者，为未来的个性化护理干预提供见解，以改善患者预后和整体健康状况。
本研究采用多种方法，包括定性和定量调查，以全面探索接受手术治疗的NSCLC患者的症状学、患者体验和治疗结果。采用前瞻性、纵向、观察性和探索性设计。将开展一项纵向定性研究，包括个体访谈和人种志实地调查，以探索患者在症状和晚期影响方面的体验以及与临床医生的互动。此外，将通过一项前瞻性问卷调查研究招募连续的计划接受手术的新诊断NSCLC患者，使用患者报告的结果。符合条件的患者将在基线以及术后2年的多个随访点完成自我报告测量，评估身体和心理社会症状负担、晚期影响、生活质量、社会支持和未满足的需求。还将收集社会人口统计学和医学特征。
本研究已获得丹麦数据保护局批准（期刊编号：2022 - 737），并按照丹麦伦理研究委员会指南和《赫尔辛基宣言II》进行。参与者将提供书面知情同意书。研究结果将在同行评审期刊上发表。
