NCT07909343Toboroz
Patient Needs and Preferences for NSCL Cancer Treatment Monitoring
Patient Needs and Preferences for Non-Small-Cell Lung Cancer Treatment Monitoring (Qualitative Phase)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 2.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 35 (tervezett)
- Első benyújtás
- 2026. szept. 22.
- Kezdés
- 2026. szept. 22.
- Elsődleges befejezés
- 2027. febr. 1.
- Fő szponzor
- European Institute of Oncology
- Betegségek
- Tüdőrák
- NCT-szám
- NCT07909343
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 35
- 2026. szept. 22. és az elsődleges befejezés (2027. febr. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| European Institute of Oncology | Milan | Olaszország | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.