Influence of a PSychological Intensive Support Program for Lung Cancer Patients ON Post-operative Outcomes: a Prospective Clinical Trial (IPSILON Trial).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 138
- 主要终点
- Hospital Anxiety and Depression Scale HADS
研究概览
简要总结
Anxiety is common among patients diagnosed with lung cancer, affecting 50-60% of cases, and over 30% report moderate to severe psychological distress. This distress includes symptoms such as depression, anxiety and social withdrawal. The waiting period before lung resection often heightens emotional tension due to fears about reduced respiratory function and postoperative dyspnea. Persistent anxiety may continue during follow-up because of the risk of recurrence and the potential need for adjuvant therapy. Previous studies have shown that high perioperative anxiety is associated with longer hospitalization, increased complications, particularly delirium and cardiac arrhythmias, and poorer adherence to treatment.
This study aims to assess whether a brief, intensive preoperative psychological intervention reduces anxiety levels in lung cancer patients, measured using the Hospital Anxiety and Depression Scale (HADS). Scores of 0-7 indicate normal levels, ≥ 8 probable anxiety or depression. Additional tools include the Visual Analogue Scale (VAS) for pain (0 = no pain, 10 = worst pain imaginable) and the Insomnia Severity Index (ISI) (0-7 no insomnia, 8-14 subthreshold, 15-21 moderate, 22-28 severe). At hospital discharge, patients were invited to complete a questionnaire about satisfaction. Measurement of psychological test will be collected at the first visit (T0), the day before surgery (T1) and 30 day after surgery (T3); VAS and ISI measurements were collected at T1, the day after surgery (T2) and 30 day after surgery (T3).
Patients are divided into three groups: an intervention group receiving four weekly 45-minute psychological sessions, a pathological control group refusing support, and a healthy control group without anxiety. Primary outcomes are changes in HADS scores between T0 and T1; secondary outcomes include complications, pain, insomnia, length of stay, and patient satisfaction. The study is a twelve-month prospective controlled trial with an estimated 46 patients per group
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •age more than 18
- •candidate to thoracic resection for lung cancer with radical intent
- •consent to participate in the research study.
排除标准
- •synchronous cancer requiring chemo or radiotherapy
- •history of chronic pain, vulnerable patients (e.g., minors and/or incapacitated subjects)
- •patients with severe psychiatric conditions (psychosis and/or personality disorders).
研究组 & 干预措施
Study Group
patients who resulted anxious at psychological tests who accepted the intensive psychological support
干预措施: HADS (Hospital Anxiety and Depression Scale) (Other)
Pathological Control Group
patients who resulted anxious at psychological tests who refused the intensive psychological support
干预措施: HADS (Hospital Anxiety and Depression Scale) (Other)
Healthy Control Group
patients who resulted not anxious at psychological tests
干预措施: HADS (Hospital Anxiety and Depression Scale) (Other)
结局指标
主要结局
Hospital Anxiety and Depression Scale HADS
时间窗: 1 day
The primary endpoint is the reduction in anxiety and depression as measured by the subscales of the Hospital Anxiety and Depression Scale (HADS) between T0 and T1 among the study groups.
次要结局
- evaluation of the incidence of complications(1 month)