patient-led follow-up from home after surgery for colorectal carcinoma

Conditions: Colorectal Carcinoma (CRC)

Summary: the primary goal of the patient-led follow-up from home, is the improvement of quality of life and the reduction of stress in patients, while obtaining a more complete picture of their health status. a series of assessments are performed in the home setting: * blood withdrawal for cea determination * quality of life questionnaires to assess both mental and physical symptoms * vital parameters using a smart sensor

primary objective: to further develop and evaluate a personalised patient-centred surveillance programme including a feedback platform for patients after curative treatment for crc in terms of health-related quality of life (hrqol) and significantly decrease the number of in-hospital appointments, by relocating the follow-up care to the home-setting. the goal is for this surveillance program to be non-inferior to standard of care follow-up at 36 months, in terms of quality of life. the quality of life in patients will be assessed with the eq 5d-5l questionnaire and compared to median eq-5d-5l scores for patients receiving standard of care follow-up. in current literature, the median hrqol vas score for patients after surgery for crc is 62.05 points (1). the second goal of the program is to relocate part of the in-hospital follow-up care to the home-setting. in standard of care follow-up, at 36 months patients would have had 10 in-hospital appointments. the effect of the promise study on the number of in-hospital appointments, will be assessed at 36 months postoperatively. the promise study is a multi-centre prospective regional implementation study of a personalised patient-centred surveillance program including a feedback platform for patients after curative treatment for crc. all patients who underwent surgery with curative intent for non-metastatic crc with scheduled postoperative surveillance are potentially eligible. follow-up in this study is performed according to the acting dutch national guidelines. current guidelines advocate cea level measurements to be performed every 3-6 months for first 2 years after surgery and every 6-12 months for years 3 to 5. medical imaging (thoracic and abdominal ct) should be performed 1 year postoperatively. changes to the dutch national guidelines during the course of the study will be implemented accordingly into the follow-up. within this study surveillance will for the greater part be performed at home: * serum cea level monitoring is performed using the automatic capillary blood withdrawal device (tap-ii) - every 6 months during the first two years and every 12 months thereafter * vital parameters will be measured with a lifesignals multi-parameter remote monitoring system - every 3 months during the first two years and every 6 months thereafter * qol is measured with the use of questionnaires - every 3 months during the first two years and every 6 months thereafter * one scheduled in hospital evaluation with medical imaging (according to national guidelines) performed 1 year after surgical treatment

Eligibility criteria:
inclusion criteria * age ≥ 21 years * histologically confirmed colorectal adenocarcinoma without distant metastasis and treated with curative intent surgical resection less than 6 months ago * scheduled or currently undergoing postoperative surveillance according to national guidelines * written informed consent by the patient * access to a smartphone exclusion criteria * patients with a severely complicated postoperative course, needing in hospital follow- up longer than 6 months postoperatively * patients enrolled in other studies that require strict adherence to any specific follow-up practice with regular imaging - yearly or more frequent - of the abdomen and/or thorax * patients with comorbidity or other malignancy that requires imaging of the abdomen and/or thorax every year or more frequent * patients with active implantable devices - e.g. pacemaker or implantable defibrillator * inability to complete the questionnaires due to illiteracy and/or insufficient proficiency of the dutch language

Keywords: colorectal carcinoma home-based follow-up patient-led capillary blood sampling biosensor eortc