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

NCT07590596 | Not Yet Recruiting

• 1 other identifier: CN-SDM-Lung 2
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pulmonary Nodule; Suspected Lung Cancer; Preoperative Decision-Making

Keywords

Shared Decision Making; Decisional Conflict; Decision Self-Efficacy; Decision Quality; Decision Regret; Pulmonary Nodule; Suspected Lung Cancer; Thoracic Surgery; Preoperative Decision-Making; Patient-Centered Care

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict Scale Score

  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.

  At enrollment during the preoperative period, before surgery

Secondary Outcomes (3)

• Decision Self-Efficacy Scale Score

  At enrollment during the preoperative period, before surgery

• Shared Decision-Making Questionnaire-9 Score

  After preoperative clinical consultation and before surgery

• Decision Regret Scale Score

  1 month after the preoperative clinical decision

Study Arms (1)

Patients With Pulmonary Nodules Suspected of Lung Cancer

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.

Other: Questionnaire-Based Decision-Making Assessment

Interventions

Questionnaire-Based Decision-Making Assessment OTHER

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.

Patients With Pulmonary Nodules Suspected of Lung Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients treated at Sichuan Cancer Hospital who have pulmonary nodules highly suspected of lung cancer before pathological confirmation and who are facing preoperative clinical decision-making. Eligible participants will be identified from thoracic surgery outpatient clinics and inpatient wards. Participants will receive routine clinical care, and study data will be collected using structured questionnaires during the preoperative period.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China

Chengdu, Sichuan, 610041, China

Location

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Xing Wei, MD

  Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xing Wei, MD

CONTACT

+86 17302886627; xing.wei@scszlyy.org.cn

Xing Wei

CONTACT

China; xing.wei@scszlyy.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Department of Thoracic Surgery

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)