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

Browse trials for

• Neoplasms, Unknown Primary 101
• Disease 2,423

Keywords

• Mobile Health
• Early Diagnosis

Neoplasms, Unknown Primary

101 studies on the registry are indexed under Neoplasms, Unknown Primary; 19 are open to participants now.

This study's planned enrollment of 200 is above the median of 52 across 63 interventional studies indexed under Neoplasms, Unknown Primary.

Lead sponsor

University of Skövde is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Study arms

• Experimental
  Access to app granted

  Participants in the experimental arm receive access to a smartphone application allowing (a) daily self-registration of physical and mental health, (b) assignment of health-promoting tasks by the care provider, (c) secure message-based communication between the patient and the care provider, and (d) a diary function for health-related notes. Self-registered data is shared with the care provider. Beyond the smartphone application, care as usual is provided.

  Other: Smartphone app enabling self-registration of physical and mental health

• No intervention
  Care as usual

  Reference group, where care as usual is provided.

Interventions

• OtherSmartphone app enabling self-registration of physical and mental health

  The intervention comprises a smartphone app enabling self-registration of physical and mental health. By responding to a brief questionnaire every day, the perceived physical and mental health will be recorded and shared with care provider.

  Also known as: Previct

Primary outcomes

1. Perceived benefit of app-supported self-registration to the diagnostic procedure, as assessed by care staff questionnaire

   For each patient in the intervention arm, the treating physician completes a study-specific questionnaire at the conclusion of the diagnostic work-up. The primary reported value is the care staff rating of the extent to which the patient's access to the Previct Mind application influenced decisions made within the diagnostic procedure, on a 5-point ordinal scale where 1 indicates no influence and 5 indicates great influence. Higher scores indicate greater perceived benefit to the diagnostic procedure.

   Time frame: Upon conclusion of the diagnostic work-up (up to 12 weeks after enrollment)

Secondary outcomes

1. Patient-rated engagement and empowerment, as assessed by study-specific patient questionnaires

   All study subjects (intervention and reference arms) complete a study-specific questionnaire at the conclusion of the diagnostic work-up, rating (a) their engagement in the care received at the Diagnostic Center on a 5-point scale where 1 indicates little engagement and 5 indicates great engagement, and (b) their preference for more or less engagement, on a 5-point scale where 1 indicates a desire for much less engagement and 5 for much more engagement. Higher scores indicate greater perceived engagement and empowerment. Scores are compared between the intervention and reference arms.

   Time frame: Upon conclusion of the diagnostic work-up (up to 12 weeks after enrollment)

2. Time from enrollment to concluded diagnosis

   Time from enrollment to the concluded diagnosis determined within care as usual, extracted from medical records, compared between the intervention arm, the reference arm, and the retrospective cohort.

   Time frame: From enrollment to concluded diagnosis (up to 12 weeks after enrollment)

3. Accuracy of an artificial intelligence or machine learning model in classifying underlying disease severity

   An artificial intelligence or machine learning model will be trained on collected data (medical history, biomarker panel results, and self-reported physical and mental health) to classify study subjects as having (1) serious disease warranting referral to the Diagnostic Center, or (2) mild disease not warranting referral. Performance is reported as Area Under the Curve (AUC) of a Receiver-Operator Characteristics (ROC) graph.

   Time frame: Through study completion, assessed once after all participants have completed the diagnostic work-up.

4. Incidence and severity of adverse events associated with data collection and use of the smartphone application

   Incidence and severity of adverse events associated with data collection and use of the application, including determination of causality. Severity is graded on a 5-point scale ranging from mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated) to death related to the adverse event. Per the protocol, adverse events attributable to this study are anticipated to be mainly limited to privacy infringement, as all medical procedures are conducted as part of care as usual. Incidence and severity of adverse events will be reported in a table.

   Time frame: From enrollment to completion of the diagnostic work-up (up to 12 weeks after enrollment)

Individual participant data

Plan to share: No — Individual participant data will not be made available to researchers outside the primary research group. The study cohort comprises a limited number of patients (at most 600 prospectively included subjects plus a retrospective cohort) investigated at a single diagnostic center in Sweden, for conditions including rare and severe diagnoses such as cancer of unknown primary. In a dataset of this size, the combination of diagnosis codes, biomarker values, demographic variables, and calendar time carries a substantial risk of re-identification of individual participants, which cannot be adequately mitigated through de-identification alone. Sharing is further constrained by obligations under the EU General Data Protection Regulation regarding personal data originating from Swedish health records, and by agreements with the commercial developer of the study application. Aggregated results will be made available through publication.