Research protocol Monitoring adverse events caused by systemic anticancer treatment – Safer Personalized Cancer Treatment digital follow-up - SPeCT HNF1626-22

Abstract

Cancer patients experience more frequently patient harm than other patients, mostly from systemic anticancer treatment. To reduce avoidable patient harm from modern anticancer treatment such as immunotherapy and targeted therapies, precise and clinically relevant measurements are needed.

The study aims through three different sub-studies 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 is not specific or sensitive enough to detect cancer-related patient harm. In recent years, three damage measurement tools for cancer have been validated based on a manual retrospective review of the patient record. Based on existing technology and research, in sub-study 1 the aim is to develop and validate a fully automatic damage measurement tool for retrospective detection of damage 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, it is important to involve the patient in their own treatment. Research on follow-up with electronic patient reported outcome measures reveal more side effects, increased quality of life and survival in cancer patients. In sub-study 2, the technology developed in sub-study 1 is used to prospectively examine whether follow-up with ePRO compared to standard follow-up results in a decrease in adverse events. In part study 3, quality of life and survival are investigated with ePRO follow-up compared to standard follow-up. Sub study 1 is a retrospective diagnostic study. Sub-studies 2 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. Sub-study 2 investigates rates, severity and types of immunotherapy related adverse events in patients monitored with ePRO compared to standard follow-up. Sub-study 3 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 patient-reported outcomes can affect patient harm and adverse events, quality of life and survival.

The study contributes to new knowledge about measurement of patient injuries and electronic 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 electronic follow-up 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 has shown to provide increased empowerment, safety, better quality of life and possible increased survival in other studies.

Kreftpasienter har overhyppighet av pasientskader, der skadene ofte skyldes systemisk kreftbehandling. For å redusere pasientskader knyttet til kreftbehandling trengs presise og klinisk relevante målinger. Dette prosjektet ønsker å videreutvikle elektroniske metoder for måling av skader hos kreftpasienter, samt å undersøke hvordan elektronisk pasientoppfølging (e-PRO) kan forebygge skader. Forskning har vist at anbefalt metode for måling av pasientskader er lite spesifikk for påvisning av kreftrelaterte skader. De siste årene er det validert tre skademålingsverktøy for kreft basert på manuell retrospektiv gjennomgang av pasientjournalen. Med utgangspunkt i eksisterende teknologi og forskning ønsker vi i delstudie 1 og 2 å videreutvikle og validere et helautomatisk skademålingsverktøy for retrospektiv påvisning av skader hos kreftpasienter. Utviklingen av den teknologiske løsningen gjøres av Datavarehuset Helse Nord og SAS Institutt, mens arbeidet med å validere og verifisere verktøyet gjøres av kandidat med intern teknisk bistand. For å forebygge skader er det viktig å involvere pasienten i egen behandling. Forskning på oppfølging med e-PRO påviser flere bivirkninger, økt livskvalitet og overlevelse hos kreftpasienter. I delstudie 2 og 3 benyttes teknologien utviklet i delstudie 1 til prospektivt å undersøke om oppfølging med e-PRO sammenlignet med standard oppfølging gir færre alvorlige skader og økt overlevelse mot en retrospektiv kontrollgruppe med standard klinisk oppfølging, samt hvordan livskvalitet påvirkes av e-PRO oppfølging. Alle delstudiene er observasjonsstudier med pasienter fra UNN, NLSH og HSYK