Huele, E. H.
van der Velden, J. M.
Kasperts, N.
Eppinga, W. S. C.
Grutters, J. P. C.
Suelmann, B. B. M.
Weening, A. A.
Delawi, D.
Teunissen, S. C. C. M.
Verkooijen, H. M.
Verlaan, J. J.
Funding for this research was provided by:
ZonMw (08440012010003)
Article History
Received: 24 February 2023
Accepted: 17 April 2023
First Online: 4 May 2023
Declarations
:
: The study received approval from the ethics committee NedMec, the Netherlands, on 19 September 2022 (reference number 22–750). With the TwiCs design, a stage-informed consent procedure is applied (12). In the first stage, at cohort entry, patients are asked for consent to participate in the cohort study (collection of medical and patient reported outcomes) and for consent to be randomized for future intervention studies within the cohort. Next, patients who are randomly selected for the intervention group in a RCT within the cohort are asked for consent to participate in the intervention study.
: No identifying or personal detail of participants will be presented in reports of trial results. The participant information materials and informed consent form are available from the corresponding author on request.
: HMV receives research funding from Elekta, European Commission, Netherlands Organisation for Health Research and Development, Dutch Cancer Foundation.