Colorectal carcinoma cancer in the colon and/or rectum
Conditions
Interventions
The intervention in this study involves home-based follow-up for patients with colorectal cancer after surgery. This includes, among other things, capillary blood sampling for health monitoring, as we
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objectives: 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). Significantly decreasing the number of in-hospital appointments. The first primary outcome for this surveillance program is non-inferiority 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 the median EQ-5D-5L VAS score, 62.05 points, of patients in standard of care follow-up. Secondly, the primary outcome consists of significantly decreasing the number of in-hospital appointments, by relocating this follow-up care to the home setting. At 36 months postoperatively patients in standard of care follow-up will have had 10 appointments in the outpatient clinic. For the patients included in the PROMISE study, a significant decrease of the number of in-hospital appointments is defined as having had a median number of in-hospital appointments at 36 months follow-up of 7 or less. | — |
Secondary
| Measure | Time frame |
|---|---|
| In this study, secondary endpoints will be: - Use of the LifeSignals biosensor: o A goal of larger than 40% of patients correctly applying the sensor and generating data from it (pilot study within the PROMISE, with the first 40 included patients) o A goal of a score of 4/5 or 5/5 for at least 33% on every patient-satisfaction question - Need for safety loop around advice regarding CEA results - Anxiety: measured by The State-Trait Anxiety Inventory: Six-Item Short-form (STAI-6) - Fear of cancer recurrence: measured by the Assessment of Survivor Concerns - Cancer Worry subscale (ASC-CW) - Survival: Both overall and cancer-specific, calculated from the date of surgical resection to the date of death or last follow-up - Cost-effectiveness - Patient and healthcare provider user satisfaction with e-Health app platform: A two item questionnaire (Appendix D) | — |
Countries
Netherlands
Contacts
Public ContactD.J. Grünhagen
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed