Patients receiving chemotherapy and/or immunotherapy for malignant and non-malignant diseases.
Conditions
Interventions
Group 1: In the preASSIST study, patients receive standard treatment, supplemented by continuous wearable-based monitoring of vital signs and physical activity, as well as app-based symptom tracking.
Sponsors
Koordinierungszentrums für Klinische Studien
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients receiving chemotherapy and/or immunotherapy for malignant and non-malignant diseases • Aged =18 and able to understand the design and objectives of the study • Signed informed consent and data protection agreement prior to any study-related activities • Willingness to wear the wearable during the treatment period and return it at a follow-up visit
Exclusion criteria
Exclusion criteria: • Medical or mental conditions (e.g., dementia) that impair the ability to wear the wearable or use the smartphone during the treatment period • Active implants (e.g., pacemakers) • Skin diseases or defects at the site of the wearable • Allergy to the wearable or its components (e.g., synthetic materials) • Conditions that exclude wearing a wearable (e.g., shunts, active bleeding) • History of non-functional hemoglobin (e.g., sickle cell anemia, recent carbon monoxide poisoning) • Language barriers preventing adequate understanding or cooperation, individuals known or suspected of non-compliance with study instructions, or individuals who, in the investigator's opinion, should not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Feasibility of the monti-platform measured as data integrity (adherence, technical functionality, data quality) during outpatient and inpatient conditions Adherence: - Daily percentage of wearable data availability. - Percentage of data availability over participation period. - Availability of each parameter per day. - Number of app-server connection attempts. - Number of uploaded vital signs. - Number of recorded ECGs. - Number of dropouts. Technical Functionality: - Ratio of failed uploads to total uploads. - Number/type of notifications sent via the app. - Number/type of user contacts. - Mean time difference between measurement and database logging. Data quality: - Mean percentage of data with high quality indices determined by the wearable for each parameter per day. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Evaluation of monti-platform usability in patients • Assessing performance of the AI model developed in CoMMoD-CAST study (UKD ID 2018-01-4549) with data generated by monti-platform and applied wearables • Evaluation of monti-platform ePRO as symptom inventory • Evaluation of neurological assessment by the monti-platform assessment tool | — |
Countries
Germany
Contacts
Public ContactGuido Kobbe
Universitätsklinikum Düsseldorf
Outcome results
None listed