Ignite Creation Date:
2024-07-17 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476158
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-10
Brief Title:
Safer Personalised Cancer Treatment Digital Follow-up
Sponsor:
Nordlandssykehuset HF
Organization:
Nordlandssykehuset HF
Study Overview
Official Title:
Monitoring of Adverse Events Caused by Systemic Cancer Treatment Identifying Adverse Events Related to Immunotherapy Treatment Before and After Implementation of Personalized Digital Patient Reported Outcomes
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPecT
Brief Summary:
The goal of this clinical trial is to investigate patient harm adverse events overall survival and health related quality of life under treatment with immunotherapy medication in cancer patients when they are followed up by a personalized digital program where the patients report symptoms directly to health care personnel
The main questions the clinical trial aims to answer are
How often and how severe are immunotherapy related adverse events side effects when patients are followed up by a digital personalized patient-reporting system compared to standard follow-up
How are life quality and survival affected for patients followed up by a digital personalized patient-reporting system compared to follow-up standard follow-up
Participants under immunotherapy cancer treatment will be followed up by a digital patient reporting program in one group and compared to a group of cancer patients receiving the same treatment but with standard follow-up without a digital program in another group Researchers will compare the two groups to see if there any differences in how many patients who develop immunotherapy related patient harm and how long the patients live
The main questions the clinical trial aims to answer are
How often and how severe are immunotherapy related adverse events side effects when patients are followed up by a digital personalized patient-reporting system compared to standard follow-up
How are life quality and survival affected for patients followed up by a digital personalized patient-reporting system compared to follow-up standard follow-up
Participants under immunotherapy cancer treatment will be followed up by a digital patient reporting program in one group and compared to a group of cancer patients receiving the same treatment but with standard follow-up without a digital program in another group Researchers will compare the two groups to see if there any differences in how many patients who develop immunotherapy related patient harm and how long the patients live
Detailed Description:
Cancer patients experience more frequently patient harm than other patients mostly from systemic anticancer treatment To reduce avoidable patient harm from modern cancer treatment such as immunotherapy and targeted therapies precise and clinically relevant measurements are needed
The study aims through three different sub-studies work pacages WP to develop electronic methods for measuring automatically injuries in cancer patients and investigate if electronic patient follow-up ePRO can prevent injuries affect quality of life and survival in patients receiving immunotherapy cancer treatment
Research has shown that the recommended method for measuring patient harm and medication related adverse events is not specific or sensitive enough to detect cancer-related patient harm In recent years three patient harm measurement tools for cancer have been validated based on a manual retrospective review of the patient record Based on existing technology and research in WP1 the aim is to develop and validate a fully automatic patient harm measurement tool for retrospective detection of harm in cancer patients receiving immunotherapy The development of the technological solution is done by Datavarehuset Helse Nord and SAS Institute in an already existing solution Nordic Clinical Analytics Framework - NCAF which is used daily in all health trusts in Helse Nord Northern Norway
In order to prevent avoidable patient harm and adverse events it is important to involve the patient in their own treatment Research on follow-up with ePRO revealed more side effects increased quality of life and overall survival in cancer patients
In WP2 the technology developed in WP1 is used to prospectively examine whether follow-up with ePRO compared to standard follow-up results in less adverse events In WP3 quality of life and survival are investigated with ePRO follow-up compared to standard follow-up WP1 is a retrospective diagnostic study WP2 and 3 are clinical cohort studies where a prospective intervention group of cancer patients are followed with ePRO during immunotherapy treatment and compared with a retrospective group of cancer patients followed with standard clinical follow-up WP2 investigates rates severity and types of immunotherapy related adverse events in patients monitored with ePRO compared to standard follow-up WP3 investigates quality of life in the ePRO cohort and overall survival in patients monitored to standard follow-up
When the study is completed in 2027 the intention is to have developed and validated an automatic measurement tool for the detection of cancer-related injuries for general use nationally and internationally and new knowledge about how and if digital follow-up with ePRO can affect patient harm and adverse events quality of life and survival
The study contributes to new knowledge about measurement of patient injuries and digital follow-up of cancer patients during active treatment with immunotherapy as a new standard of care in our region
Adverse events are an additional burden for seriously ill cancer patients By measuring adverse events that occur in cancer patients we recognize that these events happen and is a part of oncology that need to be taken to account for each individual patient Knowledge of the occurrence of adverse events in each individual department will be able to say something about status in each department so measures can be taken at a system level to improve patient safety and the quality of the health service
The use of personalized ePRO gives the patient the opportunity to participate actively in the course of their illness regardless of where and who the patient is Increased involvement of the patient inthe patient journey has shown to provide increased empowerment safety better quality of life and possible increase survival in other studies Follow-up with ePRO makes it easier for healthcare personnel to detect early signs of potential injuries so that measures can be initiated faster to mitigate potential harm
The study aims through three different sub-studies work pacages WP to develop electronic methods for measuring automatically injuries in cancer patients and investigate if electronic patient follow-up ePRO can prevent injuries affect quality of life and survival in patients receiving immunotherapy cancer treatment
Research has shown that the recommended method for measuring patient harm and medication related adverse events is not specific or sensitive enough to detect cancer-related patient harm In recent years three patient harm measurement tools for cancer have been validated based on a manual retrospective review of the patient record Based on existing technology and research in WP1 the aim is to develop and validate a fully automatic patient harm measurement tool for retrospective detection of harm in cancer patients receiving immunotherapy The development of the technological solution is done by Datavarehuset Helse Nord and SAS Institute in an already existing solution Nordic Clinical Analytics Framework - NCAF which is used daily in all health trusts in Helse Nord Northern Norway
In order to prevent avoidable patient harm and adverse events it is important to involve the patient in their own treatment Research on follow-up with ePRO revealed more side effects increased quality of life and overall survival in cancer patients
In WP2 the technology developed in WP1 is used to prospectively examine whether follow-up with ePRO compared to standard follow-up results in less adverse events In WP3 quality of life and survival are investigated with ePRO follow-up compared to standard follow-up WP1 is a retrospective diagnostic study WP2 and 3 are clinical cohort studies where a prospective intervention group of cancer patients are followed with ePRO during immunotherapy treatment and compared with a retrospective group of cancer patients followed with standard clinical follow-up WP2 investigates rates severity and types of immunotherapy related adverse events in patients monitored with ePRO compared to standard follow-up WP3 investigates quality of life in the ePRO cohort and overall survival in patients monitored to standard follow-up
When the study is completed in 2027 the intention is to have developed and validated an automatic measurement tool for the detection of cancer-related injuries for general use nationally and internationally and new knowledge about how and if digital follow-up with ePRO can affect patient harm and adverse events quality of life and survival
The study contributes to new knowledge about measurement of patient injuries and digital follow-up of cancer patients during active treatment with immunotherapy as a new standard of care in our region
Adverse events are an additional burden for seriously ill cancer patients By measuring adverse events that occur in cancer patients we recognize that these events happen and is a part of oncology that need to be taken to account for each individual patient Knowledge of the occurrence of adverse events in each individual department will be able to say something about status in each department so measures can be taken at a system level to improve patient safety and the quality of the health service
The use of personalized ePRO gives the patient the opportunity to participate actively in the course of their illness regardless of where and who the patient is Increased involvement of the patient inthe patient journey has shown to provide increased empowerment safety better quality of life and possible increase survival in other studies Follow-up with ePRO makes it easier for healthcare personnel to detect early signs of potential injuries so that measures can be initiated faster to mitigate potential harm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None