Home-based follow-up for colorectal cancer patients after surgery
Patient-empowered Remote Oncology: the Prospective, Multicentre Implementation Study - the PROMISE
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 5 sites (Breda, North Brabant and 4 other locations) |
| Trial ID | NCT06613581 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in home-based follow-up approaches, indicating potential success for this patient-led model.
Eligibility criteria
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 this trial is running
Breda, North Brabant and 4 other locations
- 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)
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
- Franciscus Gasthuis and Vlietland — Rotterdam, South Holland, Netherlands (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.