Introduction
You are invited to participate in a study to evaluate the quality of the cancer care system in Luxembourg. The purpose of this document is to inform you about the study. With this information, you will be able to decide whether or not you wish to participate. Your participation is entirely voluntary. If you decide to participate, you can withdraw at any time without giving any reason. This study was authorised by the Ministry of Health on 31/10/2022 and received a favourable opinion from the National Research Ethics Committee. However, you should not consider this last information as an incentive to participate in this study. This study is subject to the law of 8 March 2018 in relation to hospitals.
What is the purpose of the study?
Cancer in Luxembourg is a major public health issue. It is estimated that 18,000 people are currently living with cancer in the Grand Duchy, and that each year 3,000 new people are diagnosed. The most common cancers are breast cancer for women and prostate cancer for men, followed by lung cancer and colorectal cancer for both sexes. Numerous initiatives and action plans have been implemented in Luxembourg with the aim of supporting and improving the national fight against cancer: prevention campaigns, organised screening operations, epidemiological cancer surveillance (National Cancer Registry - RNC), creation of foundations and support associations, development of fundamental and clinical research, as well as the introduction of the National Cancer Plan, which is repeated periodically every 4 years. However, to date, we do not have data on the overall experience of cancer patients treated in Luxembourg, which is essential for the evaluation and improvement of the Luxembourg health system. The Colive Cancer study, which is part of the second National Cancer Plan (2020-2024), aims to make this progress possible by gathering relevant information from the experiences of patients treated for cancer in the Grand Duchy. Through this study, we want to evaluate the current cancer care system in Luxembourg, based on the direct experience of patients. We hope that around 500 people will participate in this survey. In addition, we also aim to:
• Measuring socio-economic inequalities in relation to this disease,
• Assessing access to information throughout the cancer journey,
• To determine the impact of prevention campaigns in Luxembourg.
Finally, we want to identify vocal biomarkers of common symptoms in cancer. Voice biomarkers are characteristics in the voice that can be related to our health status. Identifying such vocal biomarkers would eventually allow the development of solutions for remote monitoring of disease progression, symptoms or side effects of treatment. This would allow advances in the adaptation and personalisation of treatment and care, thus improving the quality of life of patients.
Conduct of the study
This study is an online survey, aiming to evaluate the Luxembourg cancer care system, among a sample of voluntary patients, currently in clinical care or in the last 5 years. How to participate? By visiting the link to the study you have accessed this document via a secure interface. Once you have read the information and decided to participate in the study, we invite you to complete and sign the online informed consent form to validate your participation in the study. Once you have signed the consent form, you can then access the survey itself. This survey has two independent parts:
- A questionnaire to be completed online, only once:
It is divided into 7 separate modules. The questions will cover the following areas:
• Socio-demographic data,
• Cancer: characteristics and treatments,
• Clinical pathway: diagnosis, treatment, management, care and support, and post-cancer,
• Patient-perceived experience and quality of care.
Filling in this questionnaire should take you between 20 and 40 minutes. Depending on your profile, you may not be offered all the modules. Your answers are recorded at the end of each completed module, allowing you to complete the questionnaire in several rounds if you wish to take a break. This questionnaire is intended for anyone who has been treated for cancer in Luxembourg in the last 5 years. The survey is designed as a self-administered questionnaire, so that it can be completed independently and personally. However, if your state of health does not allow you to do so and you have the possibility of being assisted by a relative, please ask for help in filling in the questionnaire, always taking into account your own experience. If you have any questions about completing this questionnaire or if you experience any problems, you can contact the study team, whose contact information is at the beginning of this information sheet.
- Voice recordings (optional):
After filling in the online questionnaire, you will be offered to participate in short voice recordings. You will be able to choose whether or not to do so. These data are important to the researchers because they hope to identify voice signals that are characteristic of a symptom or a possible cancer-related complication.
Future use of my data
This information is detailed in the "What type of data will we collect?" section of the information notice on the processing of my personal data. In addition, you are also invited to give your consent for the subsequent use (secondary use) of your data (except for your directly identifying data) for future medical research purposes. If you give your consent for future research, by ticking the box provided in the consent form, this means that your data may be made available by the LIH and used for other medical research programmes conducted by the LIH or other duly authorised national or international research organisations or biobanks, for academic and/or commercial purposes, whether in the field of cancer research or in any other biomedical research field (in population health), depending on the options you choose in the consent form. The principles described in this document will apply to future studies. In the event that these future studies are carried out by third parties (i.e. different teams from those who contributed to this study) we would like to inform you of the following:
• Information on these future studies may not be available, and the Study Leader, Principal Investigator, Sponsor and Approving Authority may be different;
• If you withdraw your consent, you will no longer be able to request the destruction of data that has already been transferred to these third parties for future studies.
Your data will only be used for studies that do not contradict the choices that you have expressed in the informed consent form. In all cases, the recipients of your data will not have access to the key that links your identity to these data.
What are the possible risks and discomforts?
Your participation in this study does not require any special consultation or further examination. Therefore, there are no foreseeable physical risks associated with your participation in the study. The main risk inherent in this study is that it is conducted exclusively online (risk of endangering the confidentiality of health and other personal data). This risk is low but there is no such thing as zero risk. The LIH has implemented important data protection measures to minimise this risk. These measures are explained in the section "How do we protect your personal data?" of the information notice on the processing of my personal data.
What are the benefits for participating in the study?
You will not benefit directly from participating in this study. Your participation is voluntary. You will not receive any compensation for your participation in this study, nor for any further developments resulting from this study. Your participation is important because you are the source of the information we need to improve cancer research.
Confidentiality and protection of personal data
LIH implements appropriate security measures, depending on the sensitivity of the data concerned, to protect your data against the risk of unauthorised access, loss, misuse, disclosure, alteration or destruction. Your data will be treated as strictly confidential. They will be pseudonymised, i.e. a confidential reference code will be used instead of your name. This code alone does not allow you to be directly identified and will only be used for scientific processing of your data. Your identity will never be disclosed in any document produced for the public or for other institutions. Only the LIH members managing the study database will have access to your personal data (name, first name, address...). As a Data Processor of LIH for data collection, Jotform, Inc. collects and stores data from consent form and the survey questionnaire on its servers located in Europe (Germany). Under no circumstances do Jotform, Inc. employees have access to data collected on Jotform, Inc.'s servers, except in exceptional cases following an explicit request from the study manager to resolve a problem. These organisations are bound by a strong obligation of security and confidentiality as required by law and the use of their services is contractually regulated. If you choose to participate in the study, your personal data will be kept, in accordance with the applicable legal provisions, for a period of 5 years following the end of the study, scheduled for the end of 2024. At the end of these 5 years, your nominative data will be destroyed. Anonymised data will be stored in accordance with the requirements of the RGPD. Please read the following information describing how we will process your personal data as part of this study (this document is available via the Colive Cancer website: www.colivecancer.lu).
Costs associated with your participation
If you decide to participate in this study, there will be no additional costs for you or your insurance company.
Insurance
The insurance policy taken out by the LIH will cover its liability in this study (Zurich, policy number 5.027.461).
Your decision to participate
Your participation in this study is entirely free and voluntary. If you decide to take part in this study, you can stop your participation at any time, and you will not be required to justify your decision. In view of your participation in the study, we are seeking your electronic consent using the form below. An electronic copy of this document will be stored securely by the LIH, and will only be accessible to a few authorised persons. You will be able to receive a copy by email to keep at the time of signing, or you can request a copy by email from the study team. If you have any questions about the study, you can contact a member of the research team at any time during the study. If you decide to participate in this study, we ask that you:
• Fully cooperate in the proper conduct of this study.
• Do not conceal any information about your health status, medications you are taking or symptoms you may have.
If you would like more information about the study, you can contact the research team at the following email address: colivecancer@lih.lu
Data Protection
As part of the Colive Cancer Study, we will collect and process some of your personal data in order to achieve the scientific objectives of the Study. The LIH is responsible for the collection of the analysis and more generally the processing of your personal data and ensures their protection, in accordance with the General Data Protection Regulation (EU) 2016/679 of 27 April 2016 (GDPR) and any subsequent text replacing or supplementing this text, in particular the Luxembourg law of 1er August 2018 on the organisation of the National Commission for Data Protection and the implementation of the GDPR (together the Data Protection Act). How do we collect your data? All study data is collected using the Jotform, Inc. electronic tool (USA), which allows for the creation of secure online questionnaires to collect data. Data collected via Jotform, Inc. is securely stored in Europe (Germany). Questionnaires are encrypted for additional security. Jotform, Inc. is the Data Processor of LIH, which is conducting the study and is used to collect data from consent form and epidemiological data from the survey questionnaire. Once collected, the data is transferred to LIH’s secure servers and permanently deleted from Jotform, Inc.'s servers.
What type of data will we collect? Your participation in the Study involves the collection of personal data about you to the extent that it is necessary to meet the scientific objectives of the Study.
1. We will collect the following data directly from you through an electronic questionnaire:
• When you connect to the study website: contact and identification details (surname, first name, date of birth, postal code, email address)
Your details will be kept separate from the data specified below,
• Individual characteristics: Socio-demographic data (such as your age, gender, country of residence and education level)
• Characteristics of your disease: Clinical information (such as type of cancer, date of diagnosis, treatments used...)
• Data concerning your care: Data on the circumstances, satisfaction, feelings about the different stages of your care (diagnosis, treatment, care...), indicators of the quality of care as you perceive it
• Technical data: Date and time of the study
2. After filling in the questionnaire, we will invite you online to make voice recordings. This part is optional and consists of 4 very short voice recordings such as: reading a short text (about 30 seconds), repeating sounds or syllables for as long as possible, free speech (Please note that the device on which you will be conducting our survey will ask you for permission to access your microphone so that the recordings can be made).
On what legal basis do we process your data? The use of your personal data is necessary to achieve the objectives of the study we are carrying out in the performance of our public interest mission and for scientific research purposes (Art. 6.1e and Art. 9.2j of the GDPR). If you agree, in order to help other Luxembourg and international research teams and thus to advance biomedical research, your anonymised or coded data may be used in several other research projects in the field of research into cancer or in any other biomedical research field (in population health), depending on the options that you choose on the consent form. In practice, if you decide to withdraw from the study, , the data that have been collected up to the date of your withdrawal will continue to be processed for scientific research or statistical purposes, in an anonymised or coded form, by the LIH or by other researchers. On the other hand, no new data concerning you will be collected by the LIH within the framework of this study and we will proceed to the deletion of data allowing you to be identified (name, first name, date of birth, address...). Who has access to your data? Only the following categories of people will have access to your data, within the limits of their respective missions: With regard to your personal data or directly identifying data (surname, first name, address, etc.):
• Authorised members of the LIH (database managers) who will have access to the Study's mapping table linking your personal data, derived from the consent form, to the pseudonym that will be assigned to you for the completion of the online survey,
• the managers of the IGSS national medico-administrative database, in order to extract your data, to allow their analysis and their aggregation (i.e. to associate them with the data collected from the other participants in the study) and this, only if you have consented to this data sharing,
• the managers of the RNC clinical database, in order to link your pseudonymised personal data with your registered RNC pseudonym, and then to allow their analysis and aggregation (i.e. linking them with data collected from other study participants), and only if you have consented to this data sharing.
For your coded (pseudonymised) or aggregated (anonymous) data:
• the Scientific Leader of the Study at the LIH and the team acting under his responsibility.
We may also give access to your data to service providers who perform services on our behalf, for example IT services (e.g. in charge of hosting or maintenance services). As Data Processor of LIH for data collection, the US company Jotform, Inc. collects and stores data from consent form and the survey questionnaire on its servers located in Europe (Germany). Under no circumstances do Jotform, Inc. employees have access to data collected on Jotform, Inc.'s servers, except in exceptional cases following an explicit request from the study manager to resolve a problem. These organisations are bound by a strong obligation of security and confidentiality as required by law and the use of their services is contractually regulated. Finally, in the context of certain controls or audits, the competent authorities may also have access to your personal data. No fully automated decision-making or profiling of your preferences, behaviours or moods is carried out on your data.
What are your rights?
You have the right to access and rectify your personal data. Under the conditions set by law*, you have the additional rights to object to the way your data is used, to request the deletion of your data and to request the restriction of certain aspects of the processing of your data. If you wish to exercise your rights, you can contact the study team by email. Finally, you have the right to lodge a complaint with the National Commission for Data Protection (CNPD) regarding the processing of your personal data. If you have any queries regarding the processing of your personal data by the LIH, you can contact the LIH's Data Protection Officer by e-mail at dpo@lih.lu or by post at the address: LUXEMBOURG INSTITUTE OF HEALTH Data Protection 1A-B, rue Thomas Edison L-1445 Strassen LUXEMBOURG * The LIH will examine all your requests to exercise rights in accordance with the GDPR and the Luxembourg law of August 1, 2018 on the organisation of its National Commission for Data Protection and the implementation of the GDPR. As a result of this assessment and to the extent that we put in place appropriate measures with regard to the protection of your data, we may have to refuse your request if the fulfilment of your request makes impossible or seriously hinders the achievement of the specific purposes of our study. We will inform you of our decision within one month upon receipt of your request. If LIH decides not to grant your request, you have the possibility to contest our decision with the CNPD.
How do we protect your personal data?
The LIH takes appropriate security measures, based on the sensitivity of the information concerned, to protect your data from the risk of unauthorised access, loss, fraudulent use, disclosure, modification and destruction. Your data will be treated as strictly confidential. It will also be pseudonymised, meaning that your name will be replaced by a confidential reference code. This code will not directly identify you and will only be used to process your data for scientific purposes. Your identity will never be disclosed in any document produced for the public or for other institutions. For your participation in the online survey, the mapping table linking the reference code to your name will be kept by the LIH in a confidential and secure manner and separate from other Study data. Only a limited number of people have access to it (see below "Who has access to your data?").
How long do we keep your data for?
Your data will be stored in a way allowing your identification during 5 years following the end of the study scheduled for the end of 2024. After this period, the table linking your identity to the other data will be deleted.
Transfers of data outside the European Union.
Your data may be transmitted outside the European Union where this is necessary for the implementation of the research or the exploitation of its results. Only anonymous data or data which does not allow you to be directly identified (coded or pseudonymised data) will be transmitted outside the European Union. It is possible that some countries outside the European Union / European Economic Area do not offer the same level of privacy protection as your country. If this is the case, LIH will put in place appropriate measures to ensure the protection of your personal data (e.g. by including standard contractual data protection clauses in its contracts, by complying with codes of conduct, by complying with a certification mechanism or by relying on your explicit consent). For more detailed information on the appropriate measures implemented by the LIH, you can send a written request to the LIH's Data Protection Officer by e-mail to dpo@lih.lu.