NCT07260227

Influence of a PSychological Intensive Support Program for Lung Cancer Patients ON Post-operative Outcomes.

Influence of a PSychological Intensive Support Program for Lung Cancer Patients ON Post-operative Outcomes: a Prospective Clinical Trial (IPSILON Trial).

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• NSCLC
• Anxiety Postoperative
• Depression

Interventions

Type	Name	Description
OTHER	HADS (Hospital Anxiety and Depression Scale)	The psychological treatment, for those patients who accepted the enrollment, consists of a weekly 45-minute psychological session for 4 weeks before the recovery in the thoracic department for lung resection. 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).

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-01-31
• Completion: 2027-04-30
• First posted: 2025-12-03
• Last updated: 2025-12-03