System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Interventional Recruiting

NCT06476158 on ClinicalTrials.gov

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

  • Sponsor: Nordlandssykehuset HF
  • Collaborators: University of Tromso, Helgelandssykehuset HF, University Hospital of North Norway
  • Enrollment: 900 (Estimated)
  • Study start: 2024-06-01 (Actual)
  • Primary completion: 2025-06-01 (Estimated)
  • Study completion: 2027-12-31 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: 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.
  • Masking: None
  • PrimaryPurpose: 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.

Conditions

  • Patient Reported Outcome Measure

Intervention / Treatment

  • Device: Kaiku Health

Primary Outcome Measures

  • Incidence and severity of immunotherapy related adverse events (irAEs) (3 years)
    Incidence of irAEs per 100 patients and per patient, and severity of irAEs graded by Common Terminology Critera for Adverse Events (CTCAE) 0-5 where 0 is no harm, and 5 is death. Consequence of the irAEs are graded by National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index category E-I where E is an error contributing to or resulted in temporary harm and required intervention. I is the maximum value, where an error occurred that may have contributed to or resulted in a patient death.

Countries

Norway

Locations and Investigators

  • Nordlandssykehuset HF, Bodø, Norway (Recruiting)
    • Ellinor Haukland, MD, PhD
    • Siv Gyda Aanes, MD