Ietje Perfors

111 Methods Design The GRIP trial is a multicentre randomised controlled trial following the patient fromcancer diagnosis until threemonths after completion of primary treatment with a maximum of one year follow-up. The study was conducted in four Dutch hospitals between April 2015 and May 2017 in the region of Utrecht, the Netherlands. In addition to the usual hospital care, patients randomized to the GRIP intervention group were offered structured follow- up guidance from primary care consisting of two components: (1) a time out consultation (TOC) with the GP and (2) structured follow-up during cancer treatment by a primary care oncology nurse and the GP. For full exploration and understanding of the effects of the first component (TOC), we report these effects in this paper separately. As follow-up care was delivered after and independently from the Time Out Consultation, we expect no interference. The GRIP study protocol was published previously. 19 The study protocol was assessed by the Medical Ethical Committee of the University Medical Centre Utrecht and was considered non-eligible for full ethical review according to Dutch law (METC number 15-075/C). Patient and Public involvement The Dutch Federation of cancer patient organizations (NFK) was part of the GRIP project group. NFK contributed to the definition of research priorities and participated in the intervention and study design, including the choice of outcome measures (SDM). NFK also contributed to the writing of the manuscript. Study population and setting Patients were eligible for participation if they were aged 18 or older, newly diagnosed with either breast cancer, colorectal cancer, gynaecological cancer, lung cancer or melanoma, and scheduled for curative treatment. Patients were excluded in case of major psychiatric diseases, personality disorders, 5