The study is introduced to eligible cancer survivors as a baseline study (part 1) and a follow-up study (part 2). Study information is given and informed consent is requested for both parts separately. Cancer survivors who fulfil the inclusion criteria and not the exclusion criteria for the first part are asked to participate in the baseline study. Baseline assessment (T0) will take place after the first informed consent form is signed. After completion of the baseline assessment, participants who fulfil the inclusion criteria and not the exclusion criteria for the second part are asked to participate in the follow-up study. After the second informed consent is given, participants will be randomly allocated to one of the two study arms. Follow-up assessments will take place post-intervention (T1) and at 3-month (T2) and 6-month (T3) follow-up. In the intervention group, T1 assessment takes place 1 week after completion of Oncokompas or 2 weeks after inclusion when Oncokompas is not completed. In the control group, T1 assessment takes place 2 weeks after inclusion. Participants allocated to the control group obtain access to Oncokompas after completion of the T3 assessment. A flowchart of the RCT is shown in Fig. 1, and the schedule of enrolment, interventions and assessments (according to SPIRIT guidelines) is provided in Fig. 2.
Flowchart of the randomised controlled trial
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) schedule of enrolment, interventions and assessments
Do you have any questions about this protocol?
Post your question to gather feedback from the community. We will also invite the authors of this article to respond.