Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613581
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Patient-empowered Remote Oncology the Prospective Multicentre Implementation Study - the PROMISE
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMISE
Brief 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
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 6205 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None