Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma
- Conditions
- Colorectal Carcinoma (CRC)
- Interventions
- Other: Home-based follow-up
- Registration Number
- NCT06613581
- Lead Sponsor
- Erasmus Medical Center
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Implementation of home-based follow-up Home-based follow-up All patients within the PROMISE study are included in the 'experimental' arm. The study is set up as an implementation study, meaning that the home-based method of follow-up is applied to all patients in the study.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Amphia Hospital
🇳🇱Breda, Brabant, Netherlands
IJsselland Hospital
🇳🇱Capelle aan den IJssel, Zuid Holland, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Zuid Holland, Netherlands
Erasmus Medical Center
🇳🇱Rotterdam, Zuid Holland, Netherlands
Franciscus Gasthuis and Vlietland
🇳🇱Rotterdam, Zuid Holland, Netherlands