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

May 14, 2026 updated by: Xing Wei, MD, Sichuan Cancer Hospital and Research Institute

Preoperative Decision-Making Characteristics and Associated Mechanisms 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China
        • Contact:
        • Principal Investigator:
          • Xing Wei, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At enrollment during the preoperative period, before surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At enrollment during the preoperative period, before surgery
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.
After preoperative clinical consultation and before surgery
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.
1 month after the preoperative clinical decision

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sichuan Cancer Hospital and Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xing Wei, MD, Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CN-SDM-Lung 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly shared because the study collects sensitive clinical and decision-making information from patients before pathological confirmation. De-identified aggregate results may be reported in publications or conference presentations. Requests for de-identified data may be considered by the principal investigator and the ethics committee, subject to applicable institutional policies and participant consent.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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