Lung Cancer (NSCLC)UNIFIEDNCT07909343
Patient Needs and Preferences for NSCL Cancer Treatment Monitoring
An observational study of Lung Cancer (NSCLC), run by European Institute of Oncology at 1 site in Italy.
Trial summary
The qualitative phase of the study will consist of focus group discussions (FGDs) with patients, caregivers, and clinicians. The aim is to explore the most relevant aspects of the experience of patients with lung cancer during treatment, considering three interconnected dimensions: the biophysical dimension (physical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Focus Group Discussion
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 22 Sep 2026to 1 Mar 2027
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients: Adults (≥18 years) with histologically or cytologically confirmed NSCLC stage II-IV, who have either undergone surgery and started targeted therapy, immunotherapy, or chemo-immunotherapy, or who have not undergone surgery and are candidates for these treatments. Patients must be able to provide informed consent, understand the study materials, communicate in Italian, and participate in focus groups, including the use of DHT/mobile applications. Caregivers: Adults (≥18 years) who provide care to the patients recruited for the focus groups. They must be able to provide informed consent, understand the study materials, communicate in Italian, and participate in focus groups and use DHT/mobile applications. Clinicians: Adults (≥18 years) who treat the recruited patients and have worked for at least one year in the Thoracic Surgery Division at IEO. They must also be able to provide informed consent, understand the study materials, communicate in Italian, and participate in focus
Patients' inclusion Criteria
- Adults (≥ 18);
- Histological or cytological diagnosis of NSCLC stage II or III or IV as classified by the UICC TNM VIII Edition;
- Patients who underwent surgery for Non-Small Cell Lung Cancer diagnosis (primary cancer) and already started targeted therapy or immunotherapy or chemo-immunotherapy combination;
- Patients diagnosed with Non-Small Cell Lung Cancer (primary cancer) not treated with surgery but candidates for targeted therapy or immunotherapy or chemo-immunotherapy combination.
Patients' exclusion Criteria
- Patients who have had pneumonectomy (whole lung removal);
- Severe psychiatric illness or cognitive impairment or inadequate verbal skills that may render them incapable of informed consent (as evaluated by the clinician);
- Inability to understand study materials (as evaluated by the clinician);
- Physical or psychological impairment that prohibits their participation in focus group (as evaluated by the clinician);
- Patients unable to use DHT or mobile applications;
- Patients unable to speak Italian.
Caregivers' inclusion criteria:
- Adults (≥ 18);
- Taking care of the patients recruited for the FGD.
Caregivers' exclusion criteria:
- Severe psychiatric illness or cognitive impairment or inadequate verbal skills that may render them incapable of informed consent.
- Inability to understand study materials;
- Physical or psychological impairment that prohibits their participation in focus group;
- Unable to use DHT or mobile applications.
- Unable to speak Italian.
Clinicians' inclusion criteria:
- Adults (≥ 18);
- Treating the patients recruited for the FGD; • Have been working for at least one yea in the Thoracic Surgery Division of the IEO.
Clinicians' exclusion criteria:
- Severe psychiatric illness or cognitive impairment or inadequate verbal skills that may render them incapable of informed consent.
- Inability to understand study materials;
- Physical or psychological impairment that prohibits their participation in focus group;
- Unable to use DHT or mobile applications.
- Unable to speak Italian.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European institute of oncology
Milan, mI, 20141
Gabriella Pravvetoni, 00390223901, gabriella.pravettoni@ieo.it
About this study
Official title: Patient Needs and Preferences for Non-Small-Cell Lung Cancer Treatment Monitoring (Qualitative Phase)
The qualitative phase of the study will consist of focus group discussions (FGDs) with patients, caregivers, and clinicians. The aim is to explore the most relevant aspects of the experience of patients with lung cancer during treatment, considering three interconnected dimensions: the biophysical dimension (physical health and symptom burden), the psychological dimension (emotional, cognitive, and behavioural wellbeing), and the social dimension (social roles, relationships, and contextual resources). The study will also investigate patients' preferences and experiences regarding symptom monitoring by the clinical team during treatment.
The first step will involve a literature review on patients' preferences and experiences with lung cancer symptom monitoring during treatment. Findings will be complemented by informal discussions with clinicians and patient representatives to ensure a comprehensive understanding of patients' priorities and to identify potentially overlooked aspects.
Read more
The next step will involve FGDs with patients, caregivers, and clinicians recruited at IEO. The FGDs with patients and caregivers will be conducted in two phases. In the first phase, three FGDs will be conducted with five patients each, together with one FGD involving five caregivers. The objective will be to generate a comprehensive list of relevant attributes related to the reporting of Patient-Reported Outcomes (PROs), Patient-Reported Experience Measures (PREMs), Clinical Outcome Assessments (COAs), and the monitoring of quality of life through telemedicine systems and Digital Health Technologies (DHTs).
In the second phase, two additional FGDs will be conducted: one with five patients and one with five caregivers. These discussions will focus on refining the initial list of attributes and identifying those considered most important by participants. At the end of this phase, the Nominal Group Technique (NGT) will be used to prioritise the attributes and establish the final list.
The prioritised attributes will then be compared, with the support of clinicians, with the evidence identified in the literature. This step will ensure that all relevant aspects have been addressed and that potentially important elements not sufficiently represented during the FGDs are considered.
Finally, a focus group with clinicians will be conducted to define the different levels of the selected attributes. The resulting attributes and levels will constitute the basis for the subsequent quantitative preference study, aimed at systematically assessing the relative importance of the different aspects of treatment experience, symptom monitoring, and quality of life from the perspective of patients and other relevant stakeholders.
Read the detailed description
This qualitative phase of the study will consist of four focus group discussions (FGDs) involving patients, two involving caregivers, and one involving clinicians. This phase will explore and elicit salient elements of lung cancer treatment and its impact at the biophysical level (physical health and symptom-related burden), psychological level (emotional, cognitive, and behavioural wellbeing), and social level (social roles, relationships, and contextual resources). It will also explore patients' preferences and experiences regarding lung cancer symptom monitoring by the clinical team during treatment.
The first step will involve a literature review on patients' preferences and experiences with lung cancer symptom monitoring during treatment. Findings will be complemented by informal discussions with clinicians and patient representatives to ensure a comprehensive understanding of patients' priorities and to identify potentially overlooked aspects.
The following step will involve FGDs with patients, caregivers, and clinicians, all recruited at IEO. The FGDs with patients and caregivers will be conducted in two phases. In the first phase, three FGDs will be conducted with five patients each, together with one FGD involving five caregivers. The objective will be to generate a comprehensive list of attributes relevant to patients and caregivers regarding the reporting of Patient-Reported Outcomes (PROs), Patient-Reported Experience Measures (PREMs), Clinical Outcome Assessments (COAs), and the monitoring of quality of life through telemedicine systems and Digital Health Technologies (DHTs).
Once the initial pool of attributes has been generated, the second phase will involve two additional FGDs: one with five patients and one with five caregivers. The aim of these discussions will be to refine the initial list and identify the attributes considered most important by participants. At the end of these FGDs, the Nominal Group Technique (NGT) will be used to prioritise the attributes and establish the final list.
With the support of clinicians, the prioritised attributes identified through the FGDs will then be compared with evidence identified in the literature to ensure that all relevant elements have been addressed and that potentially important aspects not sufficiently represented during the discussions are considered.
Finally, a focus group discussion with clinicians will be conducted to define the different levels of the selected attributes. The resulting attributes and levels will then be used in the subsequent quantitative preference study.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Focus Group Discussion
- Keywords
- patient needs, patient preferences, Non-Small-Cell Lung Cancer treatment monitoring
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus Group DiscussionOther
This qualitative phase does not involve the use of any experimental devices (e.g., wearables, biomedical software with/without AI, digital platforms for biomedical signal acquisition). The study focuses exclusively on gathering participant preferences and requirements for future digital health tools.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Lung cancer (LC) patients Receives: Other: Focus Group Discussion | |
| Caregivers | Caregivers Receives: Other: Focus Group Discussion | |
| Clinicians/oncologist | Physician Receives: Other: Focus Group Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and prioritisation of attributes relevant to lung cancer treatment experience and symptom monitoring
Will be evaluated including the biophysical, psychological, and social impacts; patient and caregiver preferences and experiences regarding symptom monitoring; and PROs, PREMs, COAs, and quality-of-life monitoring through telemedicine and Digital Health Technologies (DHTs).
The final outcome will be a prioritized set of attributes and their corresponding levels, developed through focus group discussions (FGDs) and the Nominal Group Technique (NGT), to inform the subsequent quantitative preference study.
Time Frame: Through study completion, up to 12 months.
Measured: Through study completion, up to 12 months.
Secondary outcomes (1)
Exploration of experiences, needs, preferences, treatment impact, digital monitoring, and comparison with literature/clinician input.
Exploration and characterization of patients' and caregivers' experiences, needs, and preferences regarding lung cancer treatment and symptom monitoring, including the biophysical, psychological, and social impacts of treatment and the use of telemedicine systems and Digital Health Technologies (DHTs) for symptom and quality-of-life monitoring.
The study will also assess the consistency of the identified attributes with the existing literature and clinician input and define the levels of the selected attributes for the subsequent quantitative preference study.
Measured: Through study completion, up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start22 Sep 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909343
- Sponsor's protocol ID
- UID 5556
- Other IDs
- L2-712
- Acronym
- UNIFIED
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Needs and Preferences for Non-Small-Cell Lung Cancer Treatment Monitoring (Qualitative Phase)
- ClinicalTrials.gov ID
- NCT07909343
- Acronym / sponsor ID
- UNIFIED / UID 5556
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- patient needs, patient preferences, Non-Small-Cell Lung Cancer treatment monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 2 Nov 2026 (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.
The qualitative phase of the study will consist of focus group discussions (FGDs) with patients, caregivers, and clinicians. The aim is to explore the most relevant aspects of the experience of patients with lung cancer during treatment, considering three interconnected dimensions: the biophysical dimension (physical health and symptom burden), the psychological dimension (emotional, cognitive, and behavioural wellbeing), and the social dimension (social roles, relationships, and contextual resources). The study will also investigate patients' preferences and experiences regarding symptom monitoring by the clinical team during treatment.
The first step will involve a literature review on patients' preferences and experiences with lung cancer symptom monitoring during treatment. Findings will be complemented by informal discussions with clinicians and patient representatives to ensure a comprehensive understanding of patients' priorities and to identify potentially overlooked aspects.
The next step will involve FGDs with patients, caregivers, and clinicians recruited at IEO. The FGDs with patients and caregivers will be conducted in two phases. In the first phase, three FGDs will be conducted with five patients each, together with one FGD involving five caregivers. The objective will be to generate a comprehensive list of relevant attributes related to the reporting of Patient-Reported Outcomes (PROs), Patient-Reported Experience Measures (PREMs), Clinical Outcome Assessments (COAs), and the monitoring of quality of life through telemedicine systems and Digital Health Technologies (DHTs).
In the second phase, two additional FGDs will be conducted: one with five patients and one with five caregivers. These discussions will focus on refining the initial list of attributes and identifying those considered most important by participants. At the end of this phase, the Nominal Group Technique (NGT) will be used to prioritise the attributes and establish the final list.
The prioritised attributes will then be compared, with the support of clinicians, with the evidence identified in the literature. This step will ensure that all relevant aspects have been addressed and that potentially important elements not sufficiently represented during the FGDs are considered.
Finally, a focus group with clinicians will be conducted to define the different levels of the selected attributes. The resulting attributes and levels will constitute the basis for the subsequent quantitative preference study, aimed at systematically assessing the relative importance of the different aspects of treatment experience, symptom monitoring, and quality of life from the perspective of patients and other relevant stakeholders.
Detailed description
This qualitative phase of the study will consist of four focus group discussions (FGDs) involving patients, two involving caregivers, and one involving clinicians. This phase will explore and elicit salient elements of lung cancer treatment and its impact at the biophysical level (physical health and symptom-related burden), psychological level (emotional, cognitive, and behavioural wellbeing), and social level (social roles, relationships, and contextual resources). It will also explore patients' preferences and experiences regarding lung cancer symptom monitoring by the clinical team during treatment.
The first step will involve a literature review on patients' preferences and experiences with lung cancer symptom monitoring during treatment. Findings will be complemented by informal discussions with clinicians and patient representatives to ensure a comprehensive understanding of patients' priorities and to identify potentially overlooked aspects.
The following step will involve FGDs with patients, caregivers, and clinicians, all recruited at IEO. The FGDs with patients and caregivers will be conducted in two phases. In the first phase, three FGDs will be conducted with five patients each, together with one FGD involving five caregivers. The objective will be to generate a comprehensive list of attributes relevant to patients and caregivers regarding the reporting of Patient-Reported Outcomes (PROs), Patient-Reported Experience Measures (PREMs), Clinical Outcome Assessments (COAs), and the monitoring of quality of life through telemedicine systems and Digital Health Technologies (DHTs).
Once the initial pool of attributes has been generated, the second phase will involve two additional FGDs: one with five patients and one with five caregivers. The aim of these discussions will be to refine the initial list and identify the attributes considered most important by participants. At the end of these FGDs, the Nominal Group Technique (NGT) will be used to prioritise the attributes and establish the final list.
With the support of clinicians, the prioritised attributes identified through the FGDs will then be compared with evidence identified in the literature to ensure that all relevant elements have been addressed and that potentially important aspects not sufficiently represented during the discussions are considered.
Finally, a focus group discussion with clinicians will be conducted to define the different levels of the selected attributes. The resulting attributes and levels will then be used in the subsequent quantitative preference study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Focus Group DiscussionLung cancer (LC) patients |
| Caregivers | – | Other: Focus Group DiscussionCaregivers |
| Clinicians/oncologist | – | Other: Focus Group DiscussionPhysician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients: Adults (≥18 years) with histologically or cytologically confirmed NSCLC stage II-IV, who have either undergone surgery and started targeted therapy, immunotherapy, or chemo-immunotherapy, or who have not undergone surgery and are candidates for these treatments. Patients must be able to provide informed consent, understand the study materials, communicate in Italian, and participate in focus groups, including the use of DHT/mobile applications. Caregivers: Adults (≥18 years) who provide care to the patients recruited for the focus groups. They must be able to provide informed consent, understand the study materials, communicate in Italian, and participate in focus groups and use DHT/mobile applications. Clinicians: Adults (≥18 years) who treat the recruited patients and have worked for at least one year in the Thoracic Surgery Division at IEO. They must also be able to provide informed consent, understand the study materials, communicate in Italian, and participate in focus
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 |
|---|---|---|
| Focus Group DiscussionThis qualitative phase does not involve the use of any experimental devices (e.g., wearables, biomedical software with/without AI, digital platforms for biomedical signal acquisition). The study focuses exclusively on gathering participant preferences and requirements for future digital health tools. | Other | Caregivers, Clinicians/oncologist, Patient |
Primary outcome
Identification and prioritisation of attributes relevant to lung cancer treatment experience and symptom monitoring
Time frame: Through study completion, up to 12 months.
Will be evaluated including the biophysical, psychological, and social impacts; patient and caregiver preferences and experiences regarding symptom monitoring; and PROs, PREMs, COAs, and quality-of-life monitoring through telemedicine and Digital Health Technologies (DHTs). The final outcome will be a prioritized set of attributes and their corresponding levels, developed through focus group discussions (FGDs) and the Nominal Group Technique (NGT), to inform the subsequent quantitative preference study. Time Frame: Through study completion, up to 12 months.
1 secondary outcome
Exploration of experiences, needs, preferences, treatment impact, digital monitoring, and comparison with literature/clinician input.
Time frame: Through study completion, up to 12 months.
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 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (NSCLC), run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Gabriella Pravettoni (00390223901, gabriella.pravettoni@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification and prioritisation of attributes relevant to lung cancer treatment experience and symptom monitoring (time frame: Through study completion, up to 12 months.). 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 2 Nov 2026.