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

NCT07260227 | Not Yet Recruiting

• 1 other identifier: 8086
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• evaluation of the incidence of complications

  1 month

Study Arms (3)

Study Group

EXPERIMENTAL

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

Other: HADS (Hospital Anxiety and Depression Scale)

Pathological Control Group

ACTIVE COMPARATOR

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

Other: HADS (Hospital Anxiety and Depression Scale)

Healthy Control Group

ACTIVE COMPARATOR

patients who resulted not anxious at psychological tests

Other: HADS (Hospital Anxiety and Depression Scale)

Interventions

HADS (Hospital Anxiety and Depression Scale) OTHER

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).

Also known as: psychological evaluation

Healthy Control Group; Pathological Control Group; Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Depression

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Maria Teresa Congedo

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Teresa Congedo

CONTACT

+ 390630156845; mariateresa.congedo@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11