Follow-up after surgery for liver metastases: the FUTURE-mets study

INTERVENTION: Follow‐up will be performed for up to 3 years after randomization in both study arms. Patients allocated to arm A will undergo current standard of care (physician‐controlled) surveillance, which consists of CEA level measurements, imaging and clinical evaluations at the hospital every 3 months during the first 2 years of follow‐up after randomization and every 6 months thereafter. Patients allocated to arm B will enrol in a patient‐controlled surveillance strategy. In this study arm blood sampling will be performed at home by the patients themselves using a self‐administered blood‐sampling kit. Serum CEA monitoring will be performed every 3 months during the first 2 years of follow‐up after randomization and every 6 months thereafter, Further clinical evaluation and CT‐scans will be performed in case of symptoms, CEA levels above 5 µg/L or a greater than 25% increase of CEA levels compared to the prior measurement. Patients allocated to arm B will have one planned thoracoabdominal CT‐scan and clinical evaluation 1 year after randomization. In case of normal CEA values, patients decide whether clinical evaluation and imaging will be performed. CONDITION: Colorectal cancer, Colorectal liver metastasis, Shared decision making, Quality of life ; ; PRIMARY OUTCOME: The primary outcome of this trial is the quality of life. The effect of follow‐up on health related quality of life will be assessed by the validated European Organisation for Research and Treatment of Cancer core quality of life questionnaire – Emotional Functioning Scale (EORTC QLQ‐C30‐EFS). SECONDARY OUTCOME: In addition to evaluating the quality of life using a retrospective questionnaire, ecological momentary assessment will also be performed. The momentary quality of life is considered one of the secondary endpoints and will be evaluated every 10 days for the entire duration of the study by requesting patients to complete the Life Evaluation Index (LEI) from the larger Gallup Healthways Well‐Being Index (GHWBI) on their smartphone (or computer if desired). ; ; The other secondary outcomes are anxiety (measured by the State‐Trait Anxiety Inventory: six‐item short‐form (STAI‐6)), fear of cancer recurrence (measured by the cancer‐worry subscale of the assessment of survivor concerns (ASC‐CW)), survival (overall and cancer‐specific) and cost‐effectiveness. Cost‐effectiveness will be evaluated by calculating the incremental cost‐effectiveness (C/E) ratios, using the EQ‐5D‐5L questionnaire as a utility measure and by assessing the intramural costs directly associated with the follow‐up after resection of CRLM(assessed by review of medical records) and extramural costs (assessed by a selection of relevant questions from the Medical Consumption Questionnaire (iMCQ) form the institute of Medical Technology Assessment). INCLUSION CRITERIA: ‐ Patients with CRLM treated with curative intent surgery (resection and/or ablation) ‐ Age = 18 years ‐ ECOG performance status = 2 ‐ Histologically confirmed and previously resected primary colorectal carcinoma ‐ Disease‐free at three months after surgery (assessed by thoracoabdominal CT)