Trial Title:
Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma
NCT ID:
NCT06613581
Condition:
Colorectal Carcinoma (CRC)
Conditions: Official terms:
Carcinoma
Colorectal Neoplasms
Conditions: Keywords:
Colorectal carcinoma
Home-based follow-up
Patient-led
Capillary blood sampling
Biosensor
EORTC
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
All patients included in the study will be followed-up according to the home-based
follow-up protocol. The PROMISE study is an implementation study, to further develop and
improve home-based follow-up.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Home-based follow-up
Description:
Follow-up after surgery for colorectal carcinoma, performed from home, within the bounds
of the Dutch National guidelines
Arm group label:
Implementation of home-based follow-up
Summary:
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
Detailed description:
Primary Objective: To further develop and evaluate a personalised patient-centred
surveillance programme including a feedback platform for patients after curative
treatment for CRC in terms of health-related quality of life (HRQoL) and significantly
decrease the number of in-hospital appointments, by relocating the follow-up care to the
home-setting. The goal is for this surveillance program to be non-inferior to standard of
care follow-up at 36 months, in terms of quality of life. The quality of life in patients
will be assessed with the EQ 5D-5L questionnaire and compared to median EQ-5D-5L scores
for patients receiving standard of care follow-up. In current literature, the median
HRQoL VAS score for patients after surgery for CRC is 62.05 points (1).
The second goal of the program is to relocate part of the in-hospital follow-up care to
the home-setting. In standard of care follow-up, at 36 months patients would have had 10
in-hospital appointments. The effect of the PROMISE study on the number of in-hospital
appointments, will be assessed at 36 months postoperatively.
The PROMISE study is a multi-centre prospective regional implementation study of a
personalised patient-centred surveillance program including a feedback platform for
patients after curative treatment for CRC.
All patients who underwent surgery with curative intent for non-metastatic CRC with
scheduled postoperative surveillance are potentially eligible.
Follow-up in this study is performed according to the acting Dutch national guidelines.
Current guidelines advocate CEA level measurements to be performed every 3-6 months for
first 2 years after surgery and every 6-12 months for years 3 to 5. Medical imaging
(thoracic and abdominal CT) should be performed 1 year postoperatively. Changes to the
Dutch national guidelines during the course of the study will be implemented accordingly
into the follow-up.
Within this study surveillance will for the greater part be performed at home:
- Serum CEA level monitoring is performed using the automatic capillary blood
withdrawal device (TAP-II) - every 6 months during the first two years and every 12
months thereafter
- Vital parameters will be measured with a LifeSignals Multi-parameter Remote
Monitoring System - every 3 months during the first two years and every 6 months
thereafter
- QoL is measured with the use of questionnaires - every 3 months during the first two
years and every 6 months thereafter
- One scheduled in hospital evaluation with medical imaging (according to national
guidelines) performed 1 year after surgical treatment
Criteria for eligibility:
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
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Amphia Hospital
Address:
City:
Breda
Zip:
4818CK
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Paul Gobardhan, MD, PhD
Facility:
Name:
IJsselland Hospital
Address:
City:
Capelle aan den IJssel
Zip:
2906ZC
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Pascal Doornebosch, MD, PhD
Facility:
Name:
Leiden University Medical Center
Address:
City:
Leiden
Zip:
2333ZA
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Koen C.M.J. Peeters, MD, PhD
Facility:
Name:
Erasmus Medical Center
Address:
City:
Rotterdam
Zip:
3015GD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Dirk J. Grunhagen, MD, PhD
Facility:
Name:
Franciscus Gasthuis and Vlietland
Address:
City:
Rotterdam
Zip:
3045PM
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Maria Verseveld, MD, PhD
Start date:
July 18, 2024
Completion date:
September 2031
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
Lifesignals Inc.
Agency class:
Other
Collaborator:
Agency:
YourBio Health
Agency class:
Other
Collaborator:
Agency:
TU Delft
Agency class:
Other
Collaborator:
Agency:
Amphia Hospital
Agency class:
Other
Collaborator:
Agency:
Leiden University Medical Center (LUMC)
Agency class:
Other
Collaborator:
Agency:
Franciscus Gasthuis & Vlietland (location Rotterdam)
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06613581
