Lung Neoplasms, Preoperative Counseling, Shared Decision Making, Thoracoscopic Lung Resection
Conditions
Brief summary
This study is a single-center, cluster randomized controlled trial evaluating whether lung three-dimensional model-assisted preoperative consultation can improve shared decision-making in adult patients undergoing thoracoscopic anatomical lung resection. Six attending thoracic surgeons will be randomized to provide either three-dimensional model-assisted consultation or usual preoperative consultation. Patients in the intervention group will receive consultation supported by a generic lung three-dimensional model and patient-specific three-dimensional reconstruction data generated from routine preoperative imaging. Patients in the control group will receive usual preoperative consultation according to current clinical practice. The primary outcome is patient-perceived shared decision-making measured immediately after consultation using the 9-item Shared Decision-Making Questionnaire. Secondary outcomes include anxiety, disease- and surgery-related knowledge, communication satisfaction, health-related quality of life, decision regret, consultation duration, and postoperative outcomes within 30 days.
Interventions
BEHAVIORALLung three-dimensional model and reconstruction-assisted preoperative consultation
In the intervention arm, surgeons will use a generic modular lung three-dimensional model and patient-specific three-dimensional reconstruction data to support preoperative consultation. The reconstruction will be generated from clinically indicated routine imaging examinations and will be displayed dynamically on a physician workstation. The surgeon will use these tools to explain the lesion location, involved lobe or segment, planned resection extent, bronchovascular anatomy, lymph node assessment, potential risks, alternative options, and expected recovery. No additional imaging examination will be performed solely for the study.
BEHAVIORALUsual preoperative consultation
Patients in the control arm will receive usual preoperative consultation according to current clinical practice. Usual consultation may include oral explanation, review of routine computed tomography images, surgical diagrams, printed materials, and discussion of diagnosis, treatment options, risks, and expected recovery. The lung three-dimensional model and dynamic three-dimensional reconstruction display will not be used.
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the visible nature of the communication intervention, surgeons and participants cannot be blinded. Research staff responsible for questionnaire administration, clinical outcome extraction, and statistical analysis will be blinded to group allocation whenever feasible.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or older. 2. Scheduled to undergo elective thoracoscopic anatomical lung resection for suspected or confirmed lung tumors, defined as lobectomy or segmentectomy. 3. The planned operation and relevant alternatives can be reasonably discussed during preoperative consultation by the attending thoracic surgeon. 4. Clinically stable and able to participate in preoperative consultation. 5. Able to read, understand, and complete Chinese questionnaires independently or with neutral assistance from research staff. 6. Able and willing to provide written informed consent. -
Exclusion criteria
1. Emergency surgery. 2. Planned wedge resection only, pneumonectomy, extrapleural pneumonectomy, or non-thoracoscopic open surgery at recruitment. 3. Previous major ipsilateral thoracic surgery that substantially alters thoracic anatomy and may make the generic model misleading. 4. Known cognitive impairment, severe psychiatric disorder, severe visual impairment, severe hearing impairment, or language barrier that prevents effective participation in consultation or questionnaire completion. 5. Participation in another interventional study expected to affect preoperative anxiety, patient education, decision-making, or perioperative communication. 6. Any other condition judged by the investigators to make the patient unsuitable for this study. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-perceived shared decision-making score measured by the 9-item Shared Decision-Making Questionnaire | Immediately after consultation |
Secondary
| Measure | Time frame |
|---|---|
| State anxiety score measured by the 6-item State-Trait Anxiety Inventory | Baseline before consultation, immediately after consultation, and 7 days after surgery |
| Disease- and surgery-related knowledge score | Baseline before consultation and immediately after consultation |
| Perioperative communication satisfaction score measured by the Patient Satisfaction Questionnaire Short Form | 7 days after surgery |
| Health-related quality of life measured by EQ-5D-5L | Baseline, 7 days after surgery, and 30 days after surgery |
| Decision regret score measured by the Decision Regret Scale | 7 days after surgery and 30 days after surgery |
| Consultation duration | During the preoperative consultation |
Outcome results
None listed