Colorectal Carcinoma (CRC)
Conditions
Keywords
Colorectal carcinoma, Home-based follow-up, Patient-led, Capillary blood sampling, Biosensor, EORTC
Brief 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
Detailed description
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
Interventions
OTHERHome-based follow-up
Follow-up after surgery for colorectal carcinoma, performed from home, within the bounds of the Dutch National guidelines
Sponsors
Lifesignals Inc.
YourBio Health
TU Delft
Amphia Hospital
Leiden University Medical Center (LUMC)
Franciscus Gasthuis & Vlietland (location Rotterdam)
Erasmus Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
All patients included in the study will be followed-up according to the home-based follow-up protocol. The PROMISE study is an implementation study, to further develop and improve home-based follow-up.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 36 months | The primary outcome of this study is to evaluate non-inferiority of the study follow-up with respect to the EQ-5D-5L score at 36 months of follow-up, which starts within 6 months of resection of the primary tumour. |
| Number of in hospital visits | 36 months | The second primary outcome consists of significantly decreasing the number of in-hospital appointments, by relocating this follow-up care to the home setting. This will be assessed at 36 months postoperatively. |
Countries
Netherlands
Contacts
Primary ContactElise M.H.E. van Driel, MD
Backup ContactLissa Wullaert, MD
Outcome results
None listed