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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Anxiety Postoperative; Depression; NSCLC

Treatments: Other: HADS (Hospital Anxiety and Depression Scale)

Study type: Interventional

Funder types: Other

Identifiers

NCT07260227

8086

Details and patient eligibility

About

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

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age more than 18
• candidate to thoracic resection for lung cancer with radical intent
• consent to participate in the research study.

Exclusion criteria

• 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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

138 participants in 3 patient groups

Study Group

Experimental group

Description:

patients who resulted anxious at psychological tests who accepted the intensive psychological support

Treatment:

Other: HADS (Hospital Anxiety and Depression Scale)

Pathological Control Group

Active Comparator group

Description:

patients who resulted anxious at psychological tests who refused the intensive psychological support

Treatment:

Other: HADS (Hospital Anxiety and Depression Scale)

Healthy Control Group

Active Comparator group

Description:

patients who resulted not anxious at psychological tests

Treatment:

Other: HADS (Hospital Anxiety and Depression Scale)