An observational study in Lung Cancer (NSCLC), sponsored by European Institute of Oncology. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by European Institute of Oncology · Observational
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.
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 35 is below the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →European Institute of Oncology is the lead sponsor of 185 studies on the registry; 118 are open to participants now.
Compared within Carcinoma, Non-Small-Cell Lung, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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
Patients' exclusion Criteria
Caregivers' inclusion criteria:
Caregivers' exclusion criteria:
Clinicians' inclusion criteria:
Clinicians' exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lung cancer (LC) patients
Other: Focus Group Discussion
Caregivers
Other: Focus Group Discussion
Physician
Other: Focus Group Discussion
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.
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.
Time frame: Through study completion, up to 12 months.
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.
Time frame: Through study completion, up to 12 months.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Carcinoma, Non-Small-Cell Lung →
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