Schuit, Anouk S.
Holtmaat, Karen
Hooghiemstra, Nienke
Jansen, Femke
Lissenberg-Witte, Birgit I.
Coupé, Veerle M. H.
Verdonck-de Leeuw, Irma M.
Funding for this research was provided by:
ZonMw (844001105)
Article History
Received: 29 September 2019
Accepted: 29 December 2019
First Online: 31 January 2020
Ethics approval and consent to participate
: This study will be conducted in accordance with the Declaration of Helsinki and local laws and regulations. The study protocol has been approved by the Medical Ethical Committee (METc) of VU University Medical Center (VUmc), Amsterdam, The Netherlands (2018.517). All amendments to the study protocol will be notified to the METc of VUmc.Eligible partners are fully informed about the study and are asked to participate. They have to provide written informed consent before they can participate in the study. Interested partners receive an information form about the study and are also informed by phone or in a face-to-face conversation with the researcher. Partners have ample opportunity to ask questions before they decide to participate. The intervention investigated in this trial is an online self-management application which brings negligible risks; it is expected that risks of participation in this study are negligible. There is no compensation available for trial participation; partners participating in the study get free access to Oncokompas. When unintended effects happen to participants due to Oncokompas and are reported to the Oncokompas team, these effects will be reported to the accredited METc. On the informed consent form, participants will be asked whether they agree that the research team uses their data for other research related to Oncokompas. If not, their data will not be used to answer other research questions relating Oncokompas. This trial does not involve the collection of biological specimens for storage.
: Not applicable.
: IMVdL is named as the inventor of Oncokompas, the self-management application that will be examined in this study. The other authors declare that they have no competing interests.