Ietje Perfors
89 Exclusion criteria A patient who meets any of the following criteria will be excluded from participation: • Major psychiatric disease or personality disorders. • Unable to fill in questionnaires. Patients will be first screened for in- and exclusion criteria in the hospital by nurse (practitioners) or medical doctors and secondly by the researcher. Recruitment and allocation To ensure reaching the required sample size of 150 patients, we involved all three major hospitals (one academic and two-non-academic) located in the greater urban region of Utrecht, the Netherlands, in the study. In addition, researchers will visit all sites biweekly to motivate the sites for inclusion of patients. All four GP cooperative care organisations in the region, together representing 300 GPs, and two home care organisations employing primary care oncology nurses, participate in the study. The GP cooperative care organisations inform their member GPs about the GRIP study, and the GPs can decline to collaborate by opt-out. Eligible patients will be recruited in the hospital by the treating physician or oncology nurse after the patient is informed of his/her cancer diagnosis. After verbal consent, the treating physician or oncology nurse informs the research team, who contacts the patient by phone the (working)day after diagnosis. Written informed consent is obtained from all participants by the researcher. The researcher will randomise the participants to intervention or usual care by using an computer operated electronic randomisation module, which is designed and maintained by the independent data management department of the UMC Utrecht. For randomisation, gender, date of birth, study number and site of inclusion of the patient need to be filled in on the website. Minimisation is applied to ensure balance between groups in treating hospital and cancer type. Due to the nature of the intervention, patients and healthcare providers are not blinded. 4
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