Trabjerg, Theis Bitz http://orcid.org/0000-0002-7632-8227
Jensen, Lars Henrik
Søndergaard, Jens
Sisler, Jeffrey James
Hansen, Dorte Gilså
Funding for this research was provided by:
Kræftens Bekæmpelse (R156-A10018_001)
Syddansk Universitet (14/72000)
Region of Southern Denmark (14/24231, 14/39009)
Article History
Received: 11 April 2019
Accepted: 12 June 2019
First Online: 25 June 2019
Ethics approval and consent to participate
: The Regional Ethics Committee on Biomedical Research in Denmark (S-20142000-138) and the Danish Data Protection Agency (2014-41-3534) have peer-reviewed and approved the study. Furthermore, the study protocol has been peer-reviewed as part of the enrolment procedure to the PhD School at the University of Southern Denmark.For the RCT, the outpatient clinic nurses at the Oncological Department, Vejle Hospital, Denmark will obtain informed consent from patients. The consent forms are stored at the Clinical Research Unit, Department of Oncology, Vejle Hospital.The unit of randomisation is the patient. Therefore, consent from GPs is by Danish law not required and in line with The Regional Ethics Committee on Biomedical Research instructions. However, we decided to obtain oral consent from GPs when patients are allocated to the intervention group out of courtesy to the GPs. Thereby, showing consideration to their workload. Furthermore, before study start, we sent out written information about the trial to all GPs in the Region of Southern Denmark. If a GP declined to participate their patients will not be invited for the study.GPs of patients in the control group were not contacted thus not informed about their patients’ decision to participate in the study before being asked to answer a questionnaire four months after inclusion of the patient. This procedure is in line with The Regional Ethics Committee on Biomedical Research in Denmark and Danish law.
: Not applicable. This manuscript does not contain individual person’s data.
: The authors declare that they have no competing interests.