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NCT07260227: IPSILON
Influence of a PSychological Intensive Support Program for Lung Cancer Patients ON Post-operative Outcomes.
NA trial testing HADS (Hospital Anxiety and Depression Scale) in NSCLC in 138 participants. Not yet recruiting.
31 January 2027
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 138 |
| Start date | 1 December 2025 |
| Primary completion | 31 January 2027 |
| Estimated completion | 30 April 2027 |
Drugs / interventions tested
- HADS (Hospital Anxiety and Depression Scale)
Conditions studied
- NSCLC — all drugs for NSCLC →
- Anxiety Postoperative — all drugs for Anxiety Postoperative →
- Depression — all drugs for Depression →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
18 and older, any sex, with NSCLC or Anxiety Postoperative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07260227
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07260227 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 3 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07260227.
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