Preoperative Decision-Making in Patients With Pulmonary Nodules Suspected of Lung Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSichuan Cancer Hospital and Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Questionnaire-Based Decision-Making Assessment
Other interventionParticipants 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Patients With Pulmonary Nodules Suspected of Lung Cancer1 intervention
Trial outcomes
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.
Time frame
At enrollment during the preoperative period, before surgerySecondary outcomes
1
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.
Time frame
At enrollment during the preoperative period, before surgery2
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.
Time frame
After preoperative clinical consultation and before surgery3
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.
Time frame
1 month after the preoperative clinical decisionSponsors and contacts
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Source ClinicalTrials.gov
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