Not provided
Not provided
Not provided
Not provided
Not provided
Termination due to relevant update of the operation system. Adaption of the application was not foreseen in the intervention study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Health care has an increasingly demand for mobile applications (App), but studies are rare, which explore the added value and benefits for patient and physician. Patients in different disease groups or physicians from different specialties are likely to have different demands. Research should focus on selected groups to better understand their individual demands. Our study intends to identify the added value of mobile symptom tracking in a selected subgroup of patients. We designed an App for breast cancer patients, who receive ambulant chemotherapy in a breast center. The patients track regularly their well-being and adverse events (AE) with the smartphone- or web-app and share it with the physician in the medical consultation. The data entry was designed to meet patient needs based on previous usability testing.
The reporting of AE and well-being are standardized according to the definitions by CTCAE 4.0 and ECOG-Index to ensure the reliability of patient self-reporting.
The primary outcomes are the number of reported AE, the influence on their subjective well-being and the acceptance of context specific information. We will include 150 participants in this study. The calculated power is 91% respectively 80% for a 10 % improvement of well-being and a 2.2 increase of detected AEs.
The results will be compared to patients without App and to patients with App but without shared information.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: no app | No Intervention | no use of an mobile application while treatment | |
| Group B: only app | Active Comparator | Patients, who use independently the mobile application named Consilium without involvement of the physician. |
|
| Group C: app and physician | Active Comparator | Patients use the mobile application named Consilium in collaboration with the physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consilium | Device | Patients use a mobile application to track their subjective well-being and adverse events (AE) while ambulant chemotherapy. The mobile app supports the patients in the structured and standardized entry of their data and is developed specifically for this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of reported Adverse Events | Patients report their adverse events independently in a mobile app for a period of 3 cycles of chemotherapy. The reporting of AE and well-being are standardized according to the definitions by CTCAE 4.0 and ECOG-Index to ensure the reliability of patient self-reporting. Medical consultations take place periodically every 2-3 weeks. Planned medical consultations: start-consultation with the begin of chemotherapy, first consultation before the 2nd chemotherapy cycle and second (final) consultation before the 3rd chemotherapy cycle. The observation time of each patient is 5-6 weeks. | 5-6 weeks for each patient |
| influence on patients subjective well-being | Patients report their adverse events independently in a mobile app for a period of 3 cycles of chemotherapy. The reporting of AE and well-being are standardized according to the definitions by CTCAE 4.0 and ECOG-Index to ensure the reliability of patient self-reporting. Medical consultations take place periodically every 2-3 weeks. Planned medical consultations: start-consultation with the begin of chemotherapy, first consultation before the 2nd chemotherapy cycle and second (final) consultation before the 3rd chemotherapy cycle. The observation time of each patient is 5-6 weeks. | 5-6 weeks for each patient |
Not provided
Not provided
Inclusion criteria:
Exclusion criteria:
- patients who did not meet the inclusion criteria or if compliance could be questioned, e.g. due to a psychiatric illness or personal life.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andreas Trojan, MD | University Hospital Zurich, Clinical Pharmacology and Toxicology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Clinical Pharmacology and Toxicology | Zurich | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38573759 | Derived | Trojan A, Roth S, Atassi Z, Kiessling M, Zenhaeusern R, Kadvany Y, Schumacher J, Kullak-Ublick GA, Aapro M, Eniu A. Comparison of the Real-World Reporting of Symptoms and Well-Being for the HER2-Directed Trastuzumab Biosimilar Ogivri With Registry Data for Herceptin in the Treatment of Breast Cancer: Prospective Observational Study (OGIPRO) of Electronic Patient-Reported Outcomes. JMIR Cancer. 2024 Apr 4;10:e54178. doi: 10.2196/54178. | |
| 33729162 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Derived |
| Trojan A, Battig B, Mannhart M, Seifert B, Brauchbar MN, Egbring M. Effect of Collaborative Review of Electronic Patient-Reported Outcomes for Shared Reporting in Breast Cancer Patients: Descriptive Comparative Study. JMIR Cancer. 2021 Mar 17;7(1):e26950. doi: 10.2196/26950. |
| 27601354 | Derived | Egbring M, Far E, Roos M, Dietrich M, Brauchbar M, Kullak-Ublick GA, Trojan A. A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. J Med Internet Res. 2016 Sep 6;18(9):e238. doi: 10.2196/jmir.6414. |
| D017437 |
| Skin and Connective Tissue Diseases |