Patient-Specific Three-Dimensional Thoracic Anatomical Model-Assisted Preoperative Consultation to Improve Shared Decision-Making in Patients Undergoing Thoracoscopic Lung Resection: A Single-Center Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 132
- 主要终点
- Patient-perceived shared decision-making score measured by the 9-item Shared Decision-Making Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Scheduled to undergo elective thoracoscopic anatomical lung resection for suspected or confirmed lung tumors, defined as lobectomy or segmentectomy.
- •The planned operation and relevant alternatives can be reasonably discussed during preoperative consultation by the attending thoracic surgeon.
- •Clinically stable and able to participate in preoperative consultation.
- •Able to read, understand, and complete Chinese questionnaires independently or with neutral assistance from research staff.
- •Able and willing to provide written informed consent. -
排除标准
- •Emergency surgery.
- •Planned wedge resection only, pneumonectomy, extrapleural pneumonectomy, or non-thoracoscopic open surgery at recruitment.
- •Previous major ipsilateral thoracic surgery that substantially alters thoracic anatomy and may make the generic model misleading.
- •Known cognitive impairment, severe psychiatric disorder, severe visual impairment, severe hearing impairment, or language barrier that prevents effective participation in consultation or questionnaire completion.
- •Participation in another interventional study expected to affect preoperative anxiety, patient education, decision-making, or perioperative communication.
- •Any other condition judged by the investigators to make the patient unsuitable for this study.
结局指标
主要结局
Patient-perceived shared decision-making score measured by the 9-item Shared Decision-Making Questionnaire
时间窗: Immediately after consultation
次要结局
- 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)