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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Home-based follow-up
Other interventionFollow-up after surgery for colorectal carcinoma, performed from home, within the bounds of the Dutch National guidelines
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Implementation of home-based follow-upExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Quality of life
The primary outcome of this study is to evaluate non-inferiority of the study follow-up with respect to the EQ-5D-5L score at 36 months of follow-up, which starts within 6 months of resection of the primary tumour.
Time frame
36 months2
Number of in hospital visits
The second primary outcome consists of significantly decreasing the number of in-hospital appointments, by relocating this follow-up care to the home setting. This will be assessed at 36 months postoperatively.
Time frame
36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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