Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma
Recruiting · NCT06613581 · Interventional (participants receive a specific treatment) · Lead sponsor: Erasmus Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Home-based follow-up
What this trial is about
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
Who can take part
Age range
21 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
5 locations listed.
- Amphia Hospital - Breda, North Brabant, Netherlands
- IJsselland Hospital - Capelle aan den IJssel, South Holland, Netherlands
- Leiden University Medical Center - Leiden, South Holland, Netherlands
- Erasmus Medical Center - Rotterdam, South Holland, Netherlands
- Franciscus Gasthuis and Vlietland - Rotterdam, South Holland, Netherlands