Preoperative Decision-Making in Patients With Pulmonary Nodules Suspected of Lung Cancer

Официальное название

Preoperative Decision-Making Characteristics and Associated Mechanisms in Patients With Pulmonary Nodules Suspected of Lung Cancer

Обзор

Patients with pulmonary nodules that are highly suspected to be lung cancer often need to make important treatment decisions before a definite pathological diagnosis is available. These decisions may include whether to undergo surgery, whether to continue follow-up, whether to have further diagnostic tests, and how to understand the potential benefits and risks of different management options. This prospective observational study aims to describe the preoperative decision-making status of adult patients with pulmonary nodules suspected of lung cancer. The study will assess patients' decision self-efficacy, decisional conflict, shared decision-making experience, and decision regret using standardized questionnaires. It will also explore factors associated with better or worse decision quality, such as demographic characteristics, clinical information, health literacy, doctor-patient communication, family involvement, and emotional status. No treatment or intervention will be assigned by the study. Participants will receive routine clinical care, and study data will be collected mainly through questionnaires before surgery or during the preoperative period. The findings may help clinicians identify patients who need additional decision support and improve communication during preoperative decision-making for suspected lung cancer.

Подробное описание

Pulmonary nodules that are highly suspected of malignancy represent a common and clinically challenging scenario in thoracic surgery. Before a definite pathological diagnosis is available, patients may need to make complex decisions regarding surgery, additional diagnostic procedures, active surveillance, or other management strategies. These decisions are often made under uncertainty and may be influenced by patients' understanding of medical information, perceived cancer risk, fear of treatment delay, concerns about unnecessary surgery, family involvement, and communication with clinicians.

This is a single-center, prospective observational study conducted at Sichuan Cancer Hospital. The study plans to enroll approximately 200 adult patients with pulmonary nodules highly suspected of lung cancer who are facing preoperative clinical decision-making. The study will not assign any treatment, diagnostic procedure, or behavioral intervention. All clinical management decisions will be made according to routine clinical practice and shared discussion between patients and their treating clinicians.

The primary aim of the study is to characterize preoperative decision-making among patients with pulmonary nodules suspected of lung cancer. Specifically, the study will assess decision self-efficacy, decisional conflict, and decision quality. Decision self-efficacy will be evaluated using the Decision Self-Efficacy Scale. Decisional conflict will be assessed using the Decisional Conflict Scale. Decision quality and shared decision-making experience will be evaluated using instruments such as the SDM-Q-9 and decision regret-related measures, as applicable.

The study will also explore the relationships among decision self-efficacy, decisional conflict, and decision quality. Potential associated factors may include demographic characteristics, clinical characteristics, health literacy, quality of doctor-patient communication, family involvement, emotional status, and patient preferences. Data will be collected using structured questionnaires during the preoperative outpatient or inpatient period.

Descriptive statistics will be used to summarize participant characteristics and questionnaire scores. Correlation analyses, multivariable regression models, and, if appropriate, structural equation modeling will be used to examine the associations and potential pathways linking decision self-efficacy, decisional conflict, and decision quality. The study is expected to provide evidence for identifying patients at risk of poor decision quality and for developing future decision support strategies in thoracic surgical practice.

Вмешательства

• Другое Questionnaire-Based Decision-Making Assessment
  Participants will complete structured questionnaires during the preoperative outpatient or inpatient period. The questionnaires will assess decision self-efficacy, decisional conflict, shared decision-making experience, decision regret, and related demographic and clinical factors. The study will not assign any treatment, diagnostic procedure, surgery, or decision-support intervention. All clinical care and management decisions will follow routine practice.

Первичные конечные точки

• Decisional Conflict Scale Score [Срок оценки: At enrollment during the preoperative period, before surgery]

Вторичные конечные точки (3)

• Decision Self-Efficacy Scale Score [Срок оценки: At enrollment during the preoperative period, before surgery]
• Shared Decision-Making Questionnaire-9 Score [Срок оценки: After preoperative clinical consultation and before surgery]
• Decision Regret Scale Score [Срок оценки: 1 month after the preoperative clinical decision]

Критерии участия

Критерии включения

• Age 18 years or older.
• Adult patients with pulmonary nodules that are highly suspected of malignancy based on clinical and radiological assessment.
• No definite pathological diagnosis of lung cancer before enrollment.
• Patients who are facing preoperative clinical decision-making with more than one reasonable management option, such as surgery, additional diagnostic evaluation, or follow-up.
• Able to understand the study procedures and complete the study questionnaires.
• Able and willing to provide written informed consent.

Критерии исключения

• Patients without a real clinical decision-making choice regarding the management of the pulmonary nodule.
• Patients with severe cognitive impairment or a history of severe psychiatric disease that would interfere with valid questionnaire completion.
• Patients who are unable to communicate effectively with the study staff.
• Patients who decline to participate or are unable to provide written informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, University of Electronic Sci — Чэнду

Публикации

• Pompili C, Holch P, Rogers Z, Absolom K, Clayton B, Franks K, Bekker H, Velikova G. Patients' confidence in treatment decisions for early stage non-small cell lung cancer (NSCLC). Health Qual Life Outcomes. 2020 Jul 18;18(1):237. doi: 10.1186/s12955-020-01496-9. PMID 32682425
• Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005. PMID 12926578
• Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30. PMID 19879711
• O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105. PMID 7898294
• Slatore CG, Wiener RS. Pulmonary Nodules: A Small Problem for Many, Severe Distress for Some, and How to Communicate About It. Chest. 2018 Apr;153(4):1004-1015. doi: 10.1016/j.chest.2017.10.013. Epub 2017 Oct 21. PMID 29066390
• Freiman MR, Clark JA, Slatore CG, Gould MK, Woloshin S, Schwartz LM, Wiener RS. Patients' Knowledge, Beliefs, and Distress Associated with Detection and Evaluation of Incidental Pulmonary Nodules for Cancer: Results from a Multicenter Survey. J Thorac Oncol. 2016 May;11(5):700-708. doi: 10.1016/j.jtho.2016.01.018. Epub 2016 Mar 7. PMID 26961390
• Yuan J, Xu F, Sun Y, Ren H, Chen M, Feng S. Shared decision-making in the management of pulmonary nodules: a systematic review of quantitative and qualitative studies. BMJ Open. 2024 Jul 11;14(7):e079080. doi: 10.1136/bmjopen-2023-079080. PMID 38991667

Идентификаторы

NCT: NCT07590596 · CN-SDM-Lung 2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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