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| ID | Type | Description | Link |
|---|---|---|---|
| 84788 | Other Identifier | ToetsingOnline (ABR-form) |
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| Name | Class |
|---|---|
| Lifesignals Inc. | UNKNOWN |
| YourBio Health | UNKNOWN |
| TU Delft | UNKNOWN |
| Amphia Hospital |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implementation of home-based follow-up | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based follow-up | Other | Follow-up after surgery for colorectal carcinoma, performed from home, within the bounds of the Dutch National guidelines |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | 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. | 36 months |
| Number of in hospital visits | 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. | 36 months |
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inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elise M.H.E. van Driel, MD | Contact | +310107042125 | m.h.e.vandriel@erasmusmc.nl | |
| Lissa Wullaert, MD | Contact | 0031 0107042125 | l.wullaert@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Dirk J. Grunhagen, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amphia Hospital | Not yet recruiting | Breda | North Brabant | 4818CK | Netherlands |
IPD can be shared, but exclusively upon reasonable request with the affiliated researchers
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Leiden University Medical Center (LUMC) | UNKNOWN |
| Franciscus Gasthuis & Vlietland (Hospital) | OTHER |
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.
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| IJsselland Hospital | Not yet recruiting | Capelle aan den IJssel | South Holland | 2906ZC | Netherlands |
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| Leiden University Medical Center | Not yet recruiting | Leiden | South Holland | 2333ZA | Netherlands |
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| Erasmus Medical Center | Recruiting | Rotterdam | South Holland | 3015GD | Netherlands |
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| Franciscus Gasthuis and Vlietland | Recruiting | Rotterdam | South Holland | 3045PM | Netherlands |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |