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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; NSCLC; Anxiety Postoperative
• Intervention / Treatment: Other: HADS (Hospital Anxiety and Depression Scale)

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Teresa Congedo; Phone Number: + 390630156845; Email: mariateresa.congedo@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; patients who resulted anxious at psychological tests who accepted the intensive psychological support	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).; Other Names: psychological evaluation
Active Comparator: Pathological Control Group; patients who resulted anxious at psychological tests who refused the intensive psychological support	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).; Other Names: psychological evaluation
Active Comparator: Healthy Control Group; patients who resulted not anxious at psychological tests	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).; Other Names: psychological evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale HADS	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of the incidence of complications	Secondary endpoints are to evaluate the incidence of complications (in terms of delirium, cardiac complications), perception of pain, insomnia and length of stay in the study group compared to the two control groups.	1 month

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Maria Teresa Congedo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression; 4-amino-4'-hydroxylaminodiphenylsulfone
• Other Study ID Numbers: 8086

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No