Telemedicine
Conditions
Brief summary
We designed a monocenter prospective cohort study using PROM via app and remote monitoring via pho-toplethysmography (PPG). The application of these technologies enables an early detection of infections and therefore initiation of medical interventions. The study is conducted as feasibility analysis; primary endpoints are adherence (according to wearing time) and technical robustness.
Interventions
DEVICEPPG and PROM
description will follow
Sponsors
Technical University of Munich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* gynecological cancer * indication for systemic cancer therapy * patients who are legally competent and able to understand and follow instructions of the study staff * present informed consent
Exclusion criteria
* no use if internet or applications * persons who are in a dependency or employment relationship with the study center * positive proof of COVID-19 * affection of the external auditory canal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance | 3 months | Compliance is defined as wearing time of the in-ear-sensor. |
| robustness of the ppg-signal | 3 months | number and duration of the ppg-signal transmitted |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| infections | 3 months | detection of infesctions via suspected ppg-signal transmitted or PRO-data. This results in blood test zu verify acute infections. |
| therapy modifications | 3 months | dose-reductions (%), postponing of therapy cycles (time in days between actual and plannend date), therapy discontinuation |
| number of correct- and false-positive alerts | 3 months | definition via comparison of alerts with clinical data |
| OS; PFS | 3 months | time between study inclusion and death; time between study inclusion and proven increasing tumor mass (number of days) |
| health-related costs | 3 months | cost-effectiveness analysis |
| effect on quality of life | 3 months | change in minimum 9 points in the EORTC QLQ-C30-questionnaire is evaluated as significant change. In questions 1-28: 28-112 points can be achieved: higher scores are associated with a worse outcome. In questions 29-30:2-14 points can be achieved: higher scores are associated with a better outcome. |
| number of contacts and hospitalization rates | 3 months | definition via comparison of alerts and resulting contacts and hospitalization rates with clinical data |
Countries
Germany
Outcome results
None listed