Smartphone-Based Self-Registration of Health Data in Patients With Severe Unspecific Symptoms or Cancer of Unknown Primary

This study evaluates whether self-registration of health data through a smartphone application can benefit patients undergoing diagnostic evaluation for severe unspecific symptoms (AOS) or cancer of unknown primary (CUP) at the Diagnostic Center of Skaraborg Hospital, Sweden. Approximately 200 to 600 patients will be randomized to either an intervention arm, in which they receive a smartphone application for daily self-registration of physical and mental health, secure communication with care providers, and scheduled health-promoting tasks, or a reference arm receiving care as usual. A secondary retrospective cohort of patients admitted to the Diagnostic Center after December 2021 will be included for comparison. The primary outcome is the perceived benefit of the application to the diagnostic procedure, as judged by care staff. Secondary outcomes include patient empowerment, time to diagnosis, and the ability of artificial intelligence and machine learning methods to stratify patients by severity of underlying disease. Participants will be followed for up to three months, corresponding to the duration of the standard diagnostic work-up. The study is mainly observational; all diagnostic procedures are conducted as part of care as usual.

Inclusion Criteria: * Fully informed about the nature, scope, and relevance of the study * Voluntarily agree to participation and having duly signed the Informed Consent Form * Aged 18 years or older * Access to and capable of using a regular smartphone (Android or iOS) for study subjects * referred to the DC at SkaS for diagnostic work-up according to SVF of type AOS or CUP. Exclusion Criteria: * Participating in another study which may affect the study outcome according to RP's judgement * Not able to read or understand Swedish * That according to the Declaration of Helsinki is deemed unsuitable for study enrolment * For the retrospective cohort only: Deceased