NCT06613581Recruiting
Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma
Patient-empowered Remote Oncology: the Prospective, Multicentre Implementation Study - the PROMISE
Source: ClinicalTrials.gov · Last updated 26 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 23 Sept 2024
- Start date
- 18 Jul 2024
- Primary completion date
- Sept 2029
- Lead sponsor
- Erasmus Medical Center
- Diseases
- Colorectal cancer
- NCT number
- NCT06613581
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 18 Jul 2024 to the primary completion date, Sept 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with comorbidity or other malignancy that requires imaging of the abdomen and/or thorax every year or more frequent
Other
- 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 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
Who the study is looking for
- 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
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amphia Hospital Coordinator of this site? Confirm its status | Breda | Netherlands | Not yet recruiting |
| IJsselland Hospital Coordinator of this site? Confirm its status | Capelle aan den IJssel | Netherlands | Not yet recruiting |
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Not yet recruiting |
| Franciscus Gasthuis and Vlietland Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.