Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma
ConditionColorectal Carcinoma (CRC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorErasmus Medical Center
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Home-based follow-up
Treatment groups
200 Participants
are divided into 1 treatment groupLocations
5Amphia Hospital4818CK, BredaNorth Brabant, Netherlands
IJsselland Hospital2906ZC, Capelle aan den IJsselSouth Holland, Netherlands
Leiden University Medical Center2333ZA, LeidenSouth Holland, Netherlands
Erasmus Medical Center3015GD, RotterdamSouth Holland, Netherlands
Sponsors and collaborators
Erasmus Medical Center
Lead sponsor
Lifesignals Inc.
Collaborator
YourBio Health
Collaborator
TU Delft
Collaborator
Amphia Hospital
Collaborator
Leiden University Medical Center (LUMC)
Collaborator
Franciscus Gasthuis & Vlietland (Hospital)
Collaborator
Source ClinicalTrials.gov