Validation of the European Oncology Quality of Life Toolkit

Cancer Clinical Trial

Official title:

Validation of the European Oncology Quality of Life Toolkit. A European Pilot Survey.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05947903
• Other study ID #: INT 106/23
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: June 2023
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: Cinzia Brunelli, PhD
• Phone: 00390223903387
• Email: cinzia.brunelli[@]istitutotumori.mi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The improvement or preservation of quality of life (QoL) is one of the three pillars of the European Union (EU) Mission on Cancer, which underpins the needs of patients from cancer diagnosis throughout treatment, survivorship, and advanced terminal stages. Clinical studies and real-world data show that the use of Patient Reported Outcome Measures (PROMs) for QoL assessment in routine oncology practice has positive effects on patient wellbeing and healthcare resource utilization. However, full implementation of PROMs is not yet part of standard of care and is not adequately considered in cancer policies and programs. A comprehensive tool incorporating the perspective of patients at different stages of the disease trajectory and widely applicable across Europe is still lacking. The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL, developed from preferences and priorities of people with past or current cancer experience. The EUonQoL-Kit includes three electronic questionnaires, specifically designed for different disease phases (patients in active treatment, survivors, and patients in palliative care), available in both static and dynamic (Computer Adaptive Testing, CAT) versions and in several European languages. This is a multicentre observational study, with the following aims: - The primary aim is to perform the psychometric validation of the EUonQoL-Kit. - Secondary aims are to assess its acceptability, to validate the CAT version, and to provide estimates of QoL across different European countries. The EUonQoL-Kit will be administered to a sample of cancer patients and survivors from 46 European cancer centres. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C). Each centre will recruit 100 patients (40 from group A, 30 from group B, 30 from group C), for an overall sample size of 4,600 patients (at least 4,000 patients are assumed to be enrolled, due to an expected lower recruitment rate of 10-15%). Three sub-samples of patients (each corresponding to 10% of the total sample for each centre) will fill in an additional questionnaire: - EORTC QLQ-C30, to test concurrent validity. - Live-CAT version, to test the feasibility of such implementation. - EUonQoL-Kit, 2-7 days after the first completion, to assess test-retest reliability.

Description:

Several patient-reported questionnaires have been developed and validated to measure quality of life (QoL) of cancer patients. However, a comprehensive tool, developed in close collaboration with people who have experienced cancer, widely applicable across Europe and tailored to the health status of the individual patient, is lacking. Such a tool will be important for incorporating the patient's perspective into the evaluation of policies and programs addressing cancer at the European level. The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL based on preferences of cancer patients and survivors. It is developed from a patient perspective, administered digitally, available in the languages of the European Union (EU) 27 and several associated countries, and applicable in future surveys to contribute to the EU's mission on cancer. It includes three static questionnaires specifically developed for different disease phases (patients in active treatment, survivors, and patients in palliative care), and three dynamic versions of the same questionnaires based on Item Response Theory (IRT) and Computer Adaptive Testing (CAT). This is an observational study aimed to perform the psychometric validation of the EUonQoL-Kit through its first large scale application in a pan European pilot survey. The EUonQoL-Kit will be tested in a sample of cancer patients and survivors from 46 oncological centres located in 33 European countries. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C). Each centre will recruit a sample of 100 participants (40 from group A, 30 from group B, 30 from group C), stratified for primary diagnosis: lung cancer, breast cancer, colorectal cancer, haematological malignancies, prostate cancer, others. In each centre, data collection will be performed in pre-identified outpatient clinics and inpatient wards. Participation in the study will be offered to eligible patients until the pre-defined sample size is reached. All patients in the sample will fill in the EUonQoL-Kit. Additionally, three subgroups of patients will be proposed to fill in the following additional questionnaires: - EORTC QLQ-C30, to evaluate concurrent validity ("concurrent validity" sub-sample: 10% of the overall sample, stratified for the three disease conditions: A, B, and C). - Live CAT version of the EUonQoL-Kit, to test the feasibility of such implementation ("live CAT" sub-sample: 10% of the overall sample, stratified for the three disease conditions). - EUonQoL-Kit, a second time, (2-7 days after the first administration), to assess test-retest reliability ("test-retest" sub-sample: 10% of the overall sample, stratified for the three disease conditions). The development of the EUonQoL-Kit has involved multiple stakeholder groups, also including patients, through different steps: - Systematic search, collection, and analysis of existing validated QoL tools, metrics, item banks in databases to identify QoL dimensions not adequately covered by existing tools. - A mixed-method study including patient interviews, a Delphi survey with patients and healthcare providers, aimed at collecting patient priorities and preferences on QoL dimensions, followed by a usability testing of a preliminary version of the EUonQoL-Kit. - Development of the EUonQoL-Kit, including three static questionnaires specifically developed for patients in active treatment, survivors and in palliative care, and three dynamic versions of the same questionnaires. The final version of the six questionnaires will be submitted as an amendment to the current protocol when available. - Translation and cultural adaptation of the EUonQoL-Kit across European countries. The CAT version of the EUonQoL-Kit requires an item bank containing IRT-calibrated items (questions) and an algorithm for selecting the most relevant item to ask, based on the previous answers. Such dynamic system ensures that each patient is asked the most relevant and informative items. CAT/IRT-based technology will be implemented as: - Short forms within the EUonQoL-Kit static version. Three static versions will be designed to secure the optimal fit between items and patient groups. - Live CAT, within the EUonQoL-Kit dynamic version. Each item is selected based on the previous answers, while the patient completes the questionnaire. The final EUonQoL-kit will include both traditional and CAT/IRT-based items. The overall sample size is planned to be 4,600 patients. Expecting a lower recruitment rate of 10-15%, at least 4,000 patients will be enrolled, a number suitable for data analyses. Scientifically sound recommendations on statistical power/sample size in validation studies are lacking and minimum rule-of-thumb requirements are provided. The highest number of participants recommended for exploratory and confirmatory factor analyses (EFA & CFA) is 1,000; thus, the sample size by subgroup mentioned above is appropriate to evaluate construct validity. Analyses of the primary aim will include: - EFA & CFA to assess structural validity. The sample will be divided into two random sub-samples, stratified by disease stage and country. The first sub-sample will be used to perform EFA, and the model obtained will be confirmed by CFA in the second sub-sample. Goodness-of-fit will be measured by the Root Mean Square Error of Approximation, Comparative Fit Index, and Tucker-Lewis Index. - Distribution of scale scores, examined by calculating the observed range, floor and ceiling effects, and statistics of central tendency and dispersion. - Reliability in terms of internal consistency (estimated with Cronbach's alpha coefficient of multi-item scales) and reproducibility (agreement between the two administrations of EUonQoL-Kit estimated with the Intra-class Correlation Coefficient). - Concurrent validity, assessed by the multi-trait multimethod matrix between the EUonQoL-Kit and the EORTC-QLQ-C30 questionnaire. - Construct validity based on hypotheses-testing, assessed through the patterns of EUonQoL-Kit scores across known groups defined by variables such as disease stage, treatment, and Eastern Cooperative Oncology Group performance status. Mean differences among groups will be tested with ANOVA, and the magnitude of the difference between them will be estimated by Effect Size coefficient: > 0.8 high, 0.5 moderate, and 0.2 low. - Test of Differential Item Functioning, used to assess item equivalence. Analyses of the secondary aims will include: - Assessment of acceptability and respondent burden, based on the response rate and percentage of missing items, as well as the time needed to complete the questionnaire. - Validation of the CAT version of the EUonQoL-Kit, performed by 1) comparing scores obtained with the static and dynamic versions to test if they produce interchangeable results; and 2) assessing whether the items selected for the static versions should be adjusted to obtain optimal assessment. - To analyse QoL inequalities across clusters of populations, countries, and healthcare systems, multi-level regression models will be applied across three levels: individual, cancer centre and country. It will also be explored whether the magnitude of subgroup differences (e.g., for age or education) varies across countries. - Analysis of QoL disparities across different patient groups will include gender, ethnicity, religion, geographical area, psychological and socio-economic factors, and education level. Data collected include personal information belonging to special categories, like health-related data, origins, lifestyles etc. Legal basis to collect and process information is the data subject consent, which is necessary to take part in this study. A data protection expert will assess the impact on data protection throughout the duration of the study. Patient registration and CRF data collection will be centralized through the CRF.net platform, developed and owned by Istituto Nazionale Tumori, IRCCS - Fondazione G. Pascale, Napoli (INT-NA) and released with the GPL v3 license. Data will be stored by INT-NA on cloud services provided by Telecom Italia S.p.A. and located in Acilia (Italy). Patient-reported data associated to QR codes will be collected by an ad hoc mobile app developed by Clinical Research Technology (CRT), Salerno (Italy). The CAT version of EUonQoL-Kit will be administered through the integration of a CAT engine provided by the European Organization for Research and Treatment of Cancer (EORTC), sited in Bruxelles (Belgium). Data processing is managed by: - Istituto Nazionale Tumori, IRCCS - Milan (INT): INT serves as the data controller. - Istituto Nazionale Tumori, IRCCS - Fondazione G. Pascale, Napoli (INT-NA). INT-NA will be appointed as data processor under article 28 GDPR and will be responsible for patient enrolment, questionnaire assignment through the generation of a QR code, clinician reported data collection through the electronic Case Report Form (eCRF), management of the interface with the CAT engine and with the mobile app for the administration of EUonQoL-kit items. - CRT: based on a QR code provided by CRF.net platform, the mobile app administers specific QoL questionnaires for specific subgroup of patients. For each item administered, the app will directly transfer the answer to the platform, without recording/storing any content. Such a procedure avoids any possibility to link contents to patients' IDs. - EORTC: in case of the dynamic EUonQoL-Kit administration, EORTC CAT will be appointed as data processor under article 28 GDPR and will get access to each pseudonymized answer as provided by the CRF.net platform. The EORTC CAT will delete any content once the questionnaire has been submitted including scores sent to the CRF.net platform. The CRF.net platform is accessible online by investigators and data managers through username and password and is protected through encrypted data certified by SSL certificates and HTTPS protocols. For each registered patient, the CRF.net platform generates a Quick Response (QR) code that will be scanned with the tablet to allow the patient to complete the questionnaires. The interface of the platforms allows data review and cleaning in the central archive directly (with a limited and controlled access of data-managers and investigators). Each operation done in the archive database is registered through track-change. Each participating centre will receive tablet devices from the sponsor to get access to the CRF.net platform and collect data directly from patients. Results will be shared as open data in a completely anonymous and aggregated form. After 5 years since data collection, all personal information related to the study, including informed consents, will be anonymized/destroyed according to the delay stated by the Ethics Code on data processing for statistics or scientific research purposes issued by the Italian Data Protection Authority under article 20, par. 4, LD 101/2018. Patients could exercise their rights by submitting requests to the staff identified in the private information. All centres have appointed a data protection officer under the General Data Protection Regulation (GDPR) and an internal data breach policy. This study was designed and shall be implemented and reported in accordance with national and European legal and ethical requirements. Moreover, the survey will follow the ethical principles laid down in the Declaration of Helsinki and the ethical principles of observational research on potentially fragile patients. The protocol, Informative Sheet, and Informed Consent Form must be reviewed and approved by ethics committees of each centre involved. No study procedure can be performed before the written informed consent has been provided.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or more.
• Present or past histologically confirmed diagnosis of solid tumour or haematological malignancy.
• Being in one of these three conditions: A) Patients in active treatment; B) Survivors; C) in Palliative Care.
• Native tongue or fluent in the language of the questionnaire
• Written informed consent to the study.

Exclusion Criteria:

• Cognitive impairment preventing the completion of the questionnaire

Related Conditions & MeSH terms

• Cancer
• Palliative Care
• Survivorship

Intervention

Other:
• Administration of the EUonQoL-Kit - Active Treatment questionnaire
Electronic questionnaire to be administered to patients in active treatment.
• Administration of the EUonQoL-Kit - Survivors questionnaire
Electronic questionnaire to be administered to cancer survivors.
• Administration of the EUonQoL-Kit - Palliative Care questionnaire
Electronic questionnaire to be administered to patients in palliative care.

Locations

Country	Name	City	State
Albania	Mother Teresa University Hospital	Tirana
Austria	Comprehensive Cancer Center	Vienna
Belgium	Kortrijk Kankercentrum AZ Groeninge	Kortrijk
Bulgaria	Bulgarian Joint Cancer Network	Varna
Croatia	Klinika za tumore Klinicki bolnicki centar Sestre milosrdnice	Zagreb
Cyprus	Cyprus Association of Cancer Patients and Friends (PASYKAF)	Nicosia
Czechia	Masarykuv onkologický ústav	Brno
Denmark	Region Hovedstaden (Rigshospitalet)	Hillerød
Estonia	North Estonia Medical Centre	Tallinn
Estonia	Sihtasutus Tartu Ülikooli Kliinikum	Tartu
Finland	HUS Syöpäkeskus Helsingin Yliopistollinen Sairaala	Helsinki
France	lnstitut de Cancérologie de l'Ouest (ICO)	Angers
France	Institut Curie	Paris
France	Gustave Roussy	Villejuif
Georgia	Petre Shotadze Tbilisi Medical Academy	Tbilisi
Germany	Universitäres Centrum für Tumorerkrankungen (UCT)	Frankfurt
Germany	Deutsches Krebsforschungszentrum (DKFZ)	Heidelberg
Germany	Comprehensive Cancer Center Munich	Munich
Greece	General Oncology Hospital of Athens - Saint Savvas	Athens
Hungary	Országos Onkológiai Intézet	Budapest
Ireland	Trinity St. James's Cancer Institute	Dublin
Italy	Istituto Tumori Giovanni Paolo II, IRCCS	Bari
Italy	Fondazione IRCCS Istituto Nazionale Tumori	Milan
Italy	Istituto Europeo di Oncologia, IRCCS	Milan
Italy	Istituto Nazionale Tumori Regina Elena	Roma
Latvia	Riga East University Hospital	Riga
Lithuania	National Cancer Institute	Vilnius
Moldova, Republic of	Oncologic Institute of Moldova	Chisinau
Netherlands	Netherlands Cancer Institute	Amsterdam
Norway	Oslo University Hospital (OUS)	Oslo
Poland	Greater Poland Cancer Centre	Poznan
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy	Warsaw
Portugal	Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. (IPO-Porto)	Porto
Romania	Institutul Oncologic "Al. Trestioreanu" (IOB)	Bucharest
Romania	The "Prof. Dr. Ion Chiricuta"Institute of Oncology (IOCN)	Cluj-Napoca
Serbia	Oncology Institute of Vojvodina	Sremska Kamenica
Slovakia	National Cancer Institute (Národný onkologický ústav)	Bratislava
Slovenia	Onkološki Inštitut Ljubljana	Ljubljana
Spain	Vall Hebron Institute of Oncology (VHIO)	Barcelona
Spain	Fundacion Jimenez Diaz University Hospital	Madrid
Spain	Fundación Instituto Valenciano de Oncología (IVO)	Valence
Sweden	Sahlgrenska comprehensive cancer centre	Gothenburg
Turkey	Anadolu Medical Center	Gebze
Turkey	Turkey Cancer Institute	Istanbul
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (27)

Lead Sponsor

Collaborator

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Alleanza Contro il Cancro, DEUTSCHES KREBSFORSCHUNGSZENTRUM HEIDELBERG (German Cancer Research Center), DIGICORE/IFO, EAPC, EUROPEAN CANCER ORGANISATION, European Organisation for Research and Treatment of Cancer - EORTC, FEDERATIA ASOCIATIILOR BOLNAVILOR DE CANCER, FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA, Gustave Roussy, Cancer Campus, Grand Paris, Hospital del Mar Research Institute, Institut Curie, Istituti Fisioterapici Ospitalieri, Istituto Europeo di Oncologia, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Medical University Innsbruck, ORGANISATION OF EUROPEAN CANCER INSTITUTES, Oslo universitetssykehus HF, Region Hovedstaden (Bispebjerg Hospital & Rigshospitalet), SDRUZHENIE ASOTSIATSIA NA PATSIENTITE SONKOLOGICHNI ZABOLYAVANIA I PRIYATELI, SporeData OÜ, STICHTING NEDERLANDS INSTITUUT VOOR ONDERZOEK VAN DE GEZONDHEIDSZORG, The Leeds Teaching Hospitals NHS Trust, The Netherlands Cancer Institute, UNICANCER, University of Leeds, University of Milan

Countries where clinical trial is conducted

Albania,  Austria,  Belgium,  Bulgaria,  Croatia,  Cyprus,  Czechia,  Denmark,  Estonia,  Finland,  France,  Georgia,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Latvia,  Lithuania,  Moldova, Republic of,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Serbia,  Slovakia,  Slovenia,  Spain,  Sweden,  Turkey,  United Kingdom, 

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity and reliability of the EUonQoL-Kit static version	Exploratory and confirmatory factor analyses, distribution of the scales' scores, reliability in terms of internal consistency and reproducibility, concurrent and construct validity, differential item functioning.	All assessments at time of administration of the questionnaires, apart reproducibility that will be assessed with a re-test after 7 days (± 1) for patients in active treatments and survivors, and after 2 days (± 1) for patients in palliative care
Secondary	Acceptability of the EUonQoL-Kit	Acceptability of the EUonQoL-Kit and reasons for refusal, including patient burden in filling in the questionnaire	At day 1
Secondary	Validation of the EUonQoL-Kit dynamic (CAT) version	Comparison of the scores obtained with the static and dynamic versions to test if they produce similar, interchangeable results; assessment to test whether the items selected for the static version and the related CAT-settings should be adjusted to obtain optimal assessment.	At day 1
Secondary	Assessment of Quality of Life (QoL) inequalities across clusters of European populations, countries, and healthcare systems, using EUonQoL-Kit questionnaires	Analysis of the QoL scores (dependent variable) according to individual-level variables as well as country/health system level variables (independent variables)	At day 1
Secondary	Socio-demographic and clinical factors potentially associated with QoL	Assessment of QoL disparities across different patient groups (by gender, ethnicity, religion, area, psychological and socio-economic factors, and education level)	At day 1