Clinical trial NCT06476158: Safer Personalised Cancer Treatment Digital Follow-up
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Reported Outcome Measure
Keywords: Adverse events
Patient reported outcome
Digital follow-up
Immunotherapy
Routine cancer care
Lead sponsor: Nordlandssykehuset HF
Sponsor class: OTHER
Collaborators: name: University of Tromso
name: Helgeland Hospital Trust
name: University Hospital of North Norway
First posted: 2024-06-26
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A retrospective quantitative approach will be used to develop and validate new technology and methods since there is a need to control and check the outcomes, before we use an ambi-directional cohort study design to see how the new technology and methods perform in clinical practice on real world data.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

* Above 18 years of age
* Cancer diagnosis as primary or secondary diagnosis according to the ICD-10 classification
* Receiving immunotherapy as systemic anticancer treatment reported with ATC codes for medications.

Exclusion Criteria:

* Hematological cancer
* Gynecological cancer

Primary outcomes:
measure: Incidence and severity of immunotherapy related adverse events (irAEs)
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Health related quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Nordlandssykehuset HF
state: Nordland
Study officials:
References: