Pulmonary NoduleNCT07590596
Preoperative Decision-Making in Patients With Pulmonary Nodules Suspected of Lung Cancer
An observational study of Pulmonary Nodule and Suspected Lung Cancer, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodule, Suspected Lung Cancer, Preoperative Decision-Making
- What is being tested?
- Questionnaire-Based Decision-Making Assessment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- May 2026to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China
Chengdu, Sichuan, 610041
Xing Wei, MD, +86 17302886627, xing.wei@scszlyy.org.cn
Xing Wei, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Questionnaire-Based Decision-Making Assessment
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire-Based Decision-Making AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire-Based Decision-Making Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment during the preoperative period, before surgery
Secondary outcomes (3)
Decision Self-Efficacy Scale Score
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.
Measured: At enrollment during the preoperative period, before surgery
Shared Decision-Making Questionnaire-9 Score
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.
Measured: After preoperative clinical consultation and before surgery
Decision Regret Scale Score
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.
Measured: 1 month after the preoperative clinical decision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startMay 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xing Wei, MD, Sichuan Cancer Hospital and Research Institute
- Investigators
- Xing Wei, MD, Principal investigator, Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590596
- Sponsor's protocol ID
- CN-SDM-Lung 2
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32682425Brehaut 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.
PubMed 12926578Kriston 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.
PubMed 19879711O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
PubMed 7898294Slatore 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.
PubMed 29066390Freiman 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.
PubMed 26961390Yuan 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.
PubMed 38991667
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Decision-Making Characteristics and Associated Mechanisms in Patients With Pulmonary Nodules Suspected of Lung Cancer
- ClinicalTrials.gov ID
- NCT07590596
- Acronym / sponsor ID
- CN-SDM-Lung 2
- Keywords
- Shared Decision Making, Decisional Conflict, Decision Self-Efficacy, Decision Quality, Decision Regret, Pulmonary Nodule, Suspected Lung Cancer, Thoracic Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Pulmonary Nodules Suspected of Lung Cancer | – | Other: Questionnaire-Based Decision-Making AssessmentAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire-Based Decision-Making AssessmentParticipants 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. | Other | Patients With Pulmonary Nodules Suspected of Lung Cancer |
Primary outcome
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.
3 secondary outcomes
Decision Self-Efficacy Scale Score
Time frame: At enrollment during the preoperative period, before surgery
Shared Decision-Making Questionnaire-9 Score
Time frame: After preoperative clinical consultation and before surgery
Decision Regret Scale Score
Time frame: 1 month after the preoperative clinical decision
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 32682425Pompili 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.
- Background: PubMed 12926578Brehaut 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.
- Background: PubMed 19879711Kriston 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.
- Background: PubMed 7898294O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
- Background: PubMed 29066390Slatore 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.
- Background: PubMed 26961390Freiman 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.
- Background: PubMed 38991667Yuan 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xing Wei, MD principal investigator
Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodule and Suspected Lung Cancer, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xing Wei, MD (+86 17302886627, xing.wei@scszlyy.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict Scale Score (time frame: At enrollment during the preoperative period, before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07590596, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.