Frequently Asked Questions

Study design of NET-QUBIC

Where can I find additional information about the NET-QUBIC study? 
In van Nieuwenhuizen et al. Support Care Cancer 2014 you can find information on the pilot study of NET-QUBIC. This study was performed to investigate the feasibility of performing a comprehensive assessment protocol including patient reported outcomes, physical tests, and biological sampling in newly diagnosed patients with head and neck cancer.
A study by Verdonck-de Leeuw et al. BMC Cancer 2019 contains information on the study design, flow diagram and representativeness of the included participants.

Is the NET-QUBIC study approved by a medical ethical committee? 
The study protocol is approved by the Medical Ethical Committee of VUmc (2013.301(A2018.307)-NL45051.029.13). All NET-QUBIC participants (both patients and their caregivers) provided written informed consent to participate in this study.

Who did perform the interview and physical tests and how were these persons trained?
All fieldworkers were trained to conduct the interview and physical tests by the coordinating fieldworker from Amsterdam UMC during a one-day training. In addition, all new field workers were trained by another more senior fieldworker. The new field workers first observed the senior fieldworker on a couple of home visits. After this observation period, he or she was allowed to perform the interview and the physical test under supervision. When the field worker was trained sufficiently he or she was allowed to perform the interview and physical tests independently. A detailed manual for conducting the interview and physical tests was available for all fieldworkers.

What is the background of the fieldworkers who conducted the interview and physical tests?
The fieldworkers had different backgrounds, e.g. nurse, dietician, or psychologist.

Who did administer the CIDI and how were the persons who conducted this assessment trained?
All fieldworkers were trained to conduct the CIDI by GGZ InGeest. GGZ offers a one-day training. The coordinating field worker randomly checked the CIDI interviews, as all CIDI interviews are recorded.

The exclusion criteria indicate that patients with severe psychiatric difficulties were not included in the study. How where these patients excluded? How did the elimination process look like?
Patients with severe psychiatric difficulties (e.g. Korsakov) were excluded based on the professional expertise of the physician or nurse involved in the recruitment of patients, and in consultation with the treating physician.

Why were patients with nasopharyngeal malignancies excluded?
Patients with nasopharyngeal malignancies were excluded, as the incidence of this type of tumors is relatively low in the Netherlands. Since head and neck tumors are quite heterogeneous, we limited us to the four main subtypes: oral cavity, oropharyngeal, hypopharyngeal and laryngeal cancer. In addition, patients with an unknown primary tumor were included in case it was expected that the primary tumor originated from one of the above mentioned tumor locations.

Submitting a research proposal

What do I need to do if I want to use data or samples of the NET-QUBIC study?
To make use of the NET-QUBIC data or samples please submit a research proposal with your research question to data.netqubic@amsterdamumc.nl. The NET-QUBIC steering committee will decide whether you are allowed to use the NET-QUBIC data or samples for this research question. For more detailed insight in all study procedures, please see study procedures.

When can I submit a new research proposal?
You can submit a research proposal when there is a call for new research proposals. Please check the website or ask the researchers  via data.netqubic@amsterdamumc.nl for information on the next data release.

Do I need to pay when I want to use NET-QUBIC data or samples?
Yes, we charge some money to compensate for the costs of data management needed for release of the NET-QUBIC data and samples Also applicants who are members of the NET-QUBIC Consortium have to pay the data management charge of €2,500 and (in total) €5,000 when also biobank data are needed. In case of applicants who are not members of the NET-QUBIC Consortium these charges are at least €5,000 and €10,000, respectively.

What do I have to do if I need additional (clinical) data of participants of the NET-QUBIC study?
If you need additional (clinical) data of the NET-QUBIC participants this is possible under certain circumstances. The researcher needs to collect this data him or herself or has to organize that other persons help. In all circumstances the researcher needs to check whether additional data collection is in line with the informed consent and the GDPR regulations.
In case you collect additional data you will be asked to share this with the NET-QUBIC study team, so that future researchers can make use of this data as well. This obligation is also part of the NET-QUBIC data or material transfer agreement.

Approved research project

What do I need to do before I can get access to the NET-QUBIC data and samples?
Before you can get access to the NET-QUBIC data and samples your study proposal needs to be approved by the NET-QUBIC steering committee. After this approval you need to sign either the e data transfer agreement (DTA) or material transfer agreement (MTA). In addition you need to pay the management fee.

Which agreement do I need to sign?
The type of agreement you need to sign depends on whether you want to use data or samples of the NET-QUBIC study. In case of data only, please sign the data transfer agreement (DTA). In case of data and samples, please sign the material transfer agreement (MTA).
Please see study procedures for the last version of the agreements.

How can I pay the data management fee?
Please send an e-mail to data.netqubic@amsterdamumc.nl with de title of your project, data analyses plan number, and purchase number (inkoopordernummer). After receiving this information we will sent you an invoice.

How can I retrieve the requested data?
After you signed the data transfer or material transfer agreement and paid the data management fee, we will send you an e-mail with your personal account details for the data management website. This e-mail will be sent from no-reply@kubusproject.nl. If you do not receive this e-mail please check your spam filter.

Following this e-mail, please follow the following steps:

1. Use your account details to login at the data management website of NET-QUBIC (https://data.onderzoek.io/kubus).
2. To change your password go to ‘account settings’. Please use a strong password!
3. Choose tab ‘request data’ to select the data you need for your (approved) study. At the end of the page fill in your data analyses plan number, provided as project number in the approval letter of the steering committee. Without this number your request cannot be processed.
4. The NET-QUBIC team will check (within one or two workdays) whether the requested data is in accordance with your research proposal.
5. After the approval you will receive an automatic reply that you are able to download the requested data.
6. Choose tab ‘request data’ to download your approved data (click on icons).

How can I get access to the requested data samples?
Please send an e-mail to data.netqubic@amsterdamumc.nl with the data analyses plan number of your study and provide information on the study samples requested. We try to collect all necessary samples within two weeks. However, it may sometimes take longer, especially when large amounts of samples are needed or during holiday season. Please ask for the necessary samples in time.

What do I need to know about the data protection when I use NET-QUBIC data?
You need to comply to the regulations provided in the data transfer agreement and material transfer agreement.
Please see study procedures for more information.

Do you have information why certain tests are not completed by some patients, while other tests at the same time point are completed?
Yes, we have in certain cases additional information. When the (home-based) interview and physical tests were performed, sometimes, for example, the step tests was not performed due to certain physical reasons. If you have such questions please send an email to data.netqubic@amsterdamumc.nl.

Where can I find clinical information of the included study participants?
Clinical information is available via the data file NQ_401 eCRF, which can be requested via the data release website: https://data.onderzoek.io/kubus.

Where can I find information on the representativeness of the NET-QUBIC study cohort?
A protocol paper by Verdonck-de Leeuw et al. BMC Cancer 2019 contains information on the study design, flow diagram and representativeness of the included participants. According to the General Data Protection Regulation (EU) no sociodemographic or clinical information is available on the non-responders since these people did not provide informed consent to participate in this study.

What if I need additional data files or samples not requested in the study proposal?
If you need additional data or samples not requested in the study proposal, please send an e-mail to data.netqubic@amsterdamumc.nl containing information on the additional data or samples needed and the reason why you need this additional information. In case the additional requested data is substantial, we will ask you to submit a revised study proposal, so that the steering committee can decide whether the request is granted.

What do the different types of missing (i.e. not assessed, routing, questionnaire not returned) in de data files mean?
The missing code -1, means that this question was not completed by the participant or that a domain score could not be calculated because of too much missing data. The missing code -2 ‘missing by design/routing’ means that a certain question or domain is not applicable to this specific participant (e.g. detailed questions on smoking if a participant does not smoke). The missing code -3 or -4, means that the entire questionnaire was not completed or the interview was not performed.

Who do I need to approach for co-authorship in case I use NET-QUBIC data?
The Principal Investigator and all Parties (local PIs and database, data release and biobank coordinators (See Appendix I)) that gave permission for the use of their Data will be actively approached by the lead author (or corresponding author) to participate as coauthor in the proposed multicenter paper.
For (co-)authorship, the Parties shall comply with the Vancouver Protocol, i.e. authorship credit should be based on (1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; (2) drafting the article or revising it critically for important intellectual content; and (3) final approval of the version to be published.
In all publications, the NET-QUBIC Consortium will be mentioned as a co-author, i.e. ‘(on behalf of) the NET-QUBIC Consortium.

What are the contact details of the members of the steering committee whom I need to actively approach for co-authorship?
Please send an e-mail to data.netqubic@amsterdamumc.nl for contact details.

Do I need to acknowledge the NET-QUBIC project in my paper?
Yes, the following statement needs to be added as acknowledgement in each paper: “This study was carried out using the research infrastructure within the NET-QUBIC project sponsored by the Dutch Cancer Society/Alpe d’HuZes.”

What if I have any additional questions?
Please send your question to data.netqubic@amsterdamumc.nl