Clinical trial · Observational
Preoperative Decision-Making in Patients With Pulmonary Nodules Suspected of Lung Cancer
Preoperative Decision-Making Characteristics and Associated Mechanisms in Patients With Pulmonary Nodules Suspected of Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Preoperative Decision-Making | — | UNRESOLVED | — |
| Pulmonary Nodule | — | UNRESOLVED | — |
| Suspected Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire-Based Decision-Making Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients With Pulmonary Nodules Suspected of Lung Cancer
- description
- Adult patients with pulmonary nodules highly suspected of lung cancer who are facing preoperative clinical decision-making before pathological confirmation. Participants will receive routine clinical care. No intervention, treatment assignment, or diagnostic procedure will be assigned by the study. Study data will be collected using structured questionnaires to assess decision self-efficacy, decisional conflict, shared decision-making experience, decision regret, and related clinical and demographic factors.
- interventionNames
- Other: Questionnaire-Based Decision-Making Assessment
Primary outcomes (1)
- measure
- Decisional Conflict Scale Score
- timeFrame
- At enrollment during the preoperative period, before surgery
- description
- Decisional conflict will be assessed using the Decisional Conflict Scale. The scale evaluates uncertainty in decision-making, feeling uninformed, unclear personal values, inadequate support, and perceived ineffective decision-making. The total score ranges from 0 to 100, with higher scores indicating greater decisional conflict. A score of 37.5 or higher indicates clinically important decisional conflict.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years or older. 2. Adult patients with pulmonary nodules that are highly suspected of malignancy based on clinical and radiological assessment. 3. No definite pathological diagnosis of lung cancer before enrollment. 4. Patients who are facing preoperative clinical decision-making with more than one reasonable management option, such as surgery, additional diagnostic evaluation, or follow-up. 5. Able to understand the study procedures and complete the study questionnaires. 6. Able and willing to provide written informed consent. Exclusion Criteria: 1. Patients without a real clinical decision-making choice regarding the management of the pulmonary nodule. 2. Patients with severe cognitive impairment or a history of severe psychiatric disease that would interfere with valid questionnaire completion. 3. Patients who are unable to communicate effectively with the study staff. 4. Patients who decline to participate or are unable to provide written informed consent.
References
Publications (7)
- BACKGROUNDPompili 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
- BACKGROUNDBrehaut 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
- BACKGROUNDKriston 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
- BACKGROUNDO'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105. PMID 7898294
- BACKGROUNDSlatore 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
- BACKGROUNDFreiman 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
- BACKGROUNDYuan 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.