Safer Personalised Cancer Treatment Digital Follow-up
NCT Number: NCT06476158
Acronym: SPecT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patient Reported Outcome Measure
Interventions: DEVICE: Kaiku Health
Sponsor: Nordlandssykehuset HF
Collaborators: University of Tromso|Helgelandssykehuset HF|University Hospital of North Norway
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 900
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-06-01
Completion Date: 2027-12-31
Locations: Nordlandssykehuset HF, Bodø, Nordland, 8092, Norway

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.

Primary Outcome Measures: Incidence and severity of immunotherapy related adverse events (irAEs), 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., 3 years
Secondary Outcome Measures: Overall survival, Implement personalised ePRO immunotherapy follow-up and investigate overall survival compared to standard of care from cancer diagnosis to death, and from start of immunotherapy treatment and intervention to death in the two comparing groups., 3 years|Health related quality of life, Implement personalised ePRO immunotherapy follow-up and investigate QoL in intervention group by EORTC QLQ-C30 version 3.0 including global health status, functional scales (physical, role, emotional, cognitive, social) and symptom scales at baseline ( at start cancer treatment), 3, 6 and 12 months under cancer treatment. All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL but a high score for a symptom scale represents a high level of symptomatology / problems. Firstly an estimate of the average of the items that contribute to the scale; this is the raw score. Then a linear transformation is used to standardise the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms., 3 years