Safer Personalised Cancer Treatment Digital Follow-up

NCT06476158 · tracked via the Priya Life Science Norway tracker

Sponsor

Nordlandssykehuset HF

Phase

Not applicable

Started

2024-06-01

Last updated

2024-06-26

Condition(s) studied

Patient Reported Outcome Measure

Investigational drug(s) / intervention(s)

Kaiku Health

Kaiku Health: Digital follow-up with Kaiku Health as medical device

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Nordlandssykehuset HF	Bodø	Nordland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06476158 on ClinicalTrials.gov ↗ ← All trials in Norway