Ietje Perfors

181 involved the stakeholders in the early stage of development of the GRIP trial, in order to adjust the implementation of the intervention to the local setting. For example, from the original theoretical framework we aimed at an intervention that substituted most of the psychosocial care provided by the hospital. However, the participating hospitals preferred not to adjust their usual care. As a result, the focus of the intervention changed and the GRIP program became additional care instead of substituted care. Regarding the development process of the GRIP intervention, the compliance by patients shows that the TOC and the involvement of a homecare oncology nurse do address a need, but their organisation and content was not sufficiently built on understanding of the underlying problem. Effective communication between primary care and hospital care and joint planning is vital to enable a true transmural shared care approach. 2. Feasibility A feasibility study was not conducted. Instead, we tried to promote acceptance by adjusting the intervention to the local needs and to fit in within the local healthcare pathways. Yet, conducting a pilot or feasibility study would have provided the research teamwith valuable information, such as the limitation of the timeframe in which the TOC should be performed, and might have resulted in adjustments of the GRIP intervention. A pilot study could have protected us from too optimistic estimates of subject recruitment and we might have noticed earlier that the TOC could not be properly implemented in the present care system. A recent pilot project has shown that if a secondary care worker (e.g. secretary or nurse) is made responsible for scheduling a GP consultation between diagnosis and therapy choice, the chances of a timely TOC dramatically improve (unpublished results). 3. Evaluation When evaluating a complex intervention, the MRC framework suggests a study design with randomisation, as this is the most robust method of preventing selection bias. In accordance with this recommendation 7