NSCLCIPSILONNCT07260227
Influence of a PSychological Intensive Support Program for Lung Cancer Patients ON Post-operative Outcomes.
A study testing HADS (Hospital Anxiety and Depression Scale) in people with NSCLC and Anxiety Postoperative, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Anxiety Postoperative, Depression
- What is being tested?
- HADS (Hospital Anxiety and Depression Scale)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age more than 18
- candidate to thoracic resection for lung cancer with radical intent
- consent to participate in the research study.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Conditions
- NSCLC, Anxiety Postoperative, Depression
- Being tested
- HADS (Hospital Anxiety and Depression Scale)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HADS (Hospital Anxiety and Depression Scale)Other
Also called psychological evaluation
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).
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | patients who resulted anxious at psychological tests who accepted the intensive psychological support Receives: 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 Receives: Other: HADS (Hospital Anxiety and Depression Scale) |
| Healthy Control Group | Active comparator | patients who resulted not anxious at psychological tests Receives: Other: HADS (Hospital Anxiety and Depression Scale) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Teresa Congedo, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260227
- Sponsor's protocol ID
- 8086
- Acronym
- IPSILON
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a PSychological Intensive Support Program for Lung Cancer Patients ON Post-operative Outcomes: a Prospective Clinical Trial (IPSILON Trial).
- ClinicalTrials.gov ID
- NCT07260227
- Acronym / sponsor ID
- IPSILON / 8086
- Conditions
- NSCLC, Anxiety Postoperative, Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: HADS (Hospital Anxiety and Depression Scale)patients who resulted anxious at psychological tests who accepted the intensive psychological support |
| Pathological Control Group | Active comparator | Other: HADS (Hospital Anxiety and Depression Scale)patients who resulted anxious at psychological tests who refused the intensive psychological support |
| Healthy Control Group | Active comparator | Other: HADS (Hospital Anxiety and Depression Scale)patients who resulted not anxious at psychological tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age more than 18
- candidate to thoracic resection for lung cancer with radical intent
- consent to participate in the research study.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HADS (Hospital Anxiety and Depression Scale)Also: psychological evaluationThe 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 | Healthy Control Group, Pathological Control Group, Study Group |
Primary outcome
Hospital Anxiety and Depression Scale HADS
Time frame: 1 day
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 secondary outcome
evaluation of the incidence of complications
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Teresa Congedo principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
A study testing HADS (Hospital Anxiety and Depression Scale) in people with NSCLC and Anxiety Postoperative, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Teresa Congedo (+ 390630156845, mariateresa.congedo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale HADS (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.