Home-based follow-up for colorectal cancer patients after surgery
Official title: Patient-empowered Remote Oncology: the Prospective, Multicentre Implementation Study - the PROMISE
Run by Erasmus Medical Center · NCT06613581 · Data updated 2026-11-12
This study is testing a home-based follow-up program for colorectal cancer patients after surgery to see if it can improve their quality of life and reduce stress compared to regular hospital visits.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 5 sites (Breda, North Brabant and 4 other locations) |
| Status | Recruiting |
| Started | July 18, 2024 |
| Main results expected | September 2029 |
| Study ends | September 2031 |
| Registry record updated | September 26, 2024 |
| Trial ID | NCT06613581 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 21 and older who have undergone curative surgery for non-metastatic colorectal adenocarcinoma within the last six months.
✕Probably not a fit
Patients with complicated postoperative courses requiring extended in-hospital follow-up or those enrolled in other studies with strict follow-up protocols may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to enhance the quality of life and reduce stress for colorectal cancer patients by implementing a patient-led follow-up program from home. Patients will perform blood tests for CEA determination, complete quality of life questionnaires, and monitor vital parameters using a smart sensor. The program seeks to provide a personalized surveillance experience that is non-inferior to traditional in-hospital follow-up care over a 36-month period. By relocating follow-up care to the home setting, the study also aims to decrease the number of in-hospital appointments required for these patients.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for colorectal cancer patients while reducing the burden of hospital visits.
How similar studies have gone: Other studies have shown promise in home-based follow-up approaches, indicating potential success for this patient-led model.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Erasmus Medical Center
Rotterdam, South Holland, Netherlands Recruiting -
Franciscus Gasthuis and Vlietland
Rotterdam, South Holland, Netherlands Recruiting -
Amphia Hospital
Breda, North Brabant, Netherlands Not yet recruiting -
IJsselland Hospital
Capelle aan den IJssel, South Holland, Netherlands Not yet recruiting -
Leiden University Medical Center
Leiden, South Holland, Netherlands Not yet recruiting
Study contacts
- Principal investigator: Dirk J. Grunhagen, MD, PhD — Erasmus Medical Center
- Study coordinator: Elise M.H.E. van Driel, MD
- Email: m.h.e.vandriel@erasmusmc.nl
- Phone: +310107042125
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.