Clinical trial · Interventional
Safer Personalised Cancer Treatment Digital Follow-up
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patient Reported Outcome Measure | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Kaiku Health | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Digital follow-up with e-PROs
- interventionNames
- Device: Kaiku Health
- type
- NO_INTERVENTION
- label
- Standard clinical follow-up
Primary outcomes (1)
- measure
- Incidence and severity of immunotherapy related adverse events (irAEs)
- timeFrame
- 3 years
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAanes SG, Nieder C, Bates DW, Wiig S, Haukland EC. Consequences of adverse events in cancer immunotherapy combinations - a comprehensive real-world analysis. Immunotherapy. 2025 Nov;17(16):1177-1187. doi: 10.1080/1750743X.2025.2600847. Epub 2025 Dec 10. PMID 41367243