Iris Kanera

6 135 Long-term effects of the Kanker Nazorg Wijzer METHODS Trial design and setting The long-term effects of the KNW on moderate PA and vegetable consumption were assessed by conducting a two-armed randomized controlled trial including an intervention condition (IC) and a usual care waiting list control condition (UC). After centralized registration, randomization of the participants (ratio of 1:1) was automatically performed by means of a digital randomizer at the first login to the KNW. Self-reported baseline assessment and the follow-up measurements with validated instruments after three, six, and 12 months were conducted online. In the current study, data from baseline, six, and 12-month follow- up were included into the analyses. The IC had access to the KNW throughout six months, while the UC received access to the KNW after completing the 12-month measurement. Blinding participants and researchers was not possible within this eHealth trial (Baker et al., 2010). Ethical approval for this trial (Dutch Trial Register NTR3375) was obtained from the Medical Research Ethics Committee Zuyd (NL41445.096.12, 12-T-115). After approval, the board of directors of each hospital endorsed the execution of the study. Participants and procedure Eligible individuals were adult (≥ 18 years of age), Dutch-speaking cancer survivors, diagnosed with various types of cancer, and who had completed primary cancer treatment (surgery, chemo- or radiation therapy) with curative intent at least four weeks, and up to 56 weeks prior to initial participation. Individuals with signs of cancer recurrence or severe medical, psychiatric, or cognitive disorders were excluded from participation. Details of the recruitment procedures have been published elsewhere (Kanera, et al., 2016b; Willems et al., 2017a). In short, eligible cancer survivors were recruited from November 2013 through June 2014 by medical staff from 21 Dutch outpatient clinics (internal medicine, oncology, gynecology, urology, breast cancer care) during medical consultations and by reviewing patient files. A trial information package was provided, in person or by post, including comprehensive information about the trial and about scientific research (Ministerie van Volksgezondheid, 2014), an informed consent form, a short log-in instruction guide, and a storage card with contact details and personal login codes to the KNW online baseline questionnaire. One reminder letter was send after two weeks, reminding subjects to participate in the study and to return the signed informed consent form. Data from respondents who did not return the informed consent form were excluded from analysis. Intervention The KNW is a web-based self-management program that operates without human involvement. Comprehensive descriptions of the intervention and technical details