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JOURNAL ONKOLOGIE – STUDIE

Validation of the European Oncology Quality of Life Toolkit

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NCT-Nummer:
NCT05947903

Studienbeginn:
April 2024

Letztes Update:
19.07.2023

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Collaborator:
Gustave Roussy, Cancer Campus, Grand Paris, DEUTSCHES KREBSFORSCHUNGSZENTRUM HEIDELBERG (German Cancer Research Center), Oslo universitetssykehus HF, The Netherlands Cancer Institute, Hospital del Mar Research Institute, Istituto Europeo di Oncologia, European

Studienleiter

Cinzia Brunelli, PhD
Principal Investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

Kontakt

Studienlocations
(3 von 45)

Brustzentrum Regio im Comprehensive Cancer Center Marburg
Baldingerstraße 1
35043 Marburg
Deutschland» Google-Maps
Universitäres Centrum für Tumorerkrankungen (UCT)
60590 Frankfurt
(Hessen)
Germany» Google-Maps
Klinika za tumore Klinički bolnički centar Sestre milosrdnice
10000 Zagreb
Croatia» Google-Maps
HUS Syöpäkeskus Helsingin Yliopistollinen Sairaala
00290 Helsinki
Finland» Google-Maps
General Oncology Hospital of Athens - Saint Savvas
11522 Athens
Greece» Google-Maps
Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. (IPO-Porto)
4200-072 Porto
Portugal» Google-Maps
Institutul Oncologic "Al. Trestioreanu" (IOB)
022328 Bucharest
Romania» Google-Maps
Fundación Instituto Valenciano de Oncología (IVO)
46009 Valence
Spain» Google-Maps
Sahlgrenska comprehensive cancer centre
413 45 Gothenburg
Sweden» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed 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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Validity and reliability of the EUonQoL-Kit static version (Time Frame - 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):
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.



Secondary outcome:

1. Acceptability of the EUonQoL-Kit (Time Frame - At day 1):
Acceptability of the EUonQoL-Kit and reasons for refusal, including patient burden in filling in the questionnaire

2. Validation of the EUonQoL-Kit dynamic (CAT) version (Time Frame - At day 1):
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.

3. Assessment of Quality of Life (QoL) inequalities across clusters of European populations, countries, and healthcare systems, using EUonQoL-Kit questionnaires (Time Frame - At day 1):
Analysis of the QoL scores (dependent variable) according to individual-level variables as well as country/health system level variables (independent variables)

4. Socio-demographic and clinical factors potentially associated with QoL (Time Frame - At day 1):
Assessment of QoL disparities across different patient groups (by gender, ethnicity, religion, area, psychological and socio-economic factors, and education level)

Studien-Arme

  • A) EUonQoL-Kit - Active Treatment module
    EUonQoL-Kit questionnaire specifically designed and administered to patients undergoing/having recently completed curative treatment for early-stage cancers OR undergoing/having recently completed non-curative treatment for advanced or metastatic cancers, including disease controlling/life prolonging tumour-directed treatment.
  • B) EUonQoL-Kit - Survivors module
    EUonQoL-Kit questionnaire specifically designed and administered to people being disease-free without evidence of active cancer, and at least one year off active treatment (with the exception of long-term adjuvant hormonotherapy).
  • C) EUonQoL-Kit - Palliative Care module
    EUonQoL-Kit questionnaire specifically designed and administered to patients with advanced cancers with projected prognosis <12 months and Eastern Cooperative Oncology Group (ECOG) ≥2 OR referred to a specialist palliative care team for symptom control, OR receiving non-curative systemic treatment or radiotherapy purely for symptom control.

Geprüfte Regime

  • 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.

Quelle: ClinicalTrials.gov


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