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NCT Number: NCT07590596

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Chengdu, Sichuan, 610041, China

Location contact

Xing Wei, MD

CONTACT

[email protected]

+86 17302886627

Xing Wei, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Decisional Conflict Scale Score

    Time frame: At enrollment during the preoperative period, before surgery

    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

  1. Decision Self-Efficacy Scale Score

    Time frame: At enrollment during the preoperative period, before surgery

    Decision self-efficacy will be assessed using the Decision Self-Efficacy Scale. The scale measures participants' confidence in obtaining information, understanding risks and benefits, clarifying personal values, expressing preferences, and making healthcare decisions. The total score ranges from 0 to 100, with higher scores indicating greater decision self-efficacy.

  2. Shared Decision-Making Questionnaire-9 Score

    Time frame: After preoperative clinical consultation and before surgery

    The shared decision-making experience will be assessed using the 9-item Shared Decision-Making Questionnaire. The questionnaire evaluates the participant's perception of involvement in the clinical decision-making process. The total score will be transformed to a 0-to-100 scale, with higher scores indicating a better shared decision-making experience.

  3. Decision Regret Scale Score

    Time frame: 1 month after the preoperative clinical decision

    Decision regret will be assessed using the Decision Regret Scale. The scale measures distress or remorse after a healthcare decision has been made. The total score ranges from 0 to 100, with higher scores indicating greater decision regret.

Study contacts

Contact information is provided by the study sponsor or research team.

Xing Wei

CONTACT

[email protected]

China

Xing Wei, MD

CONTACT

[email protected]

+86 17302886627

Sponsors and collaborators

Lead sponsor

Sichuan Cancer Hospital and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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