Randomized Controlled Single-blind Trial to Evaluate the Mobile Tracking of Symptoms in Ambulatory Breast Cancer Patients
NCT ID: NCT02004496
Last Updated: 2015-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
139 participants
INTERVENTIONAL
2013-12-31
2015-07-31
Brief Summary
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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.
* Trial with medical device
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Group A: no app
no use of an mobile application while treatment
No interventions assigned to this group
Group B: only app
Patients, who use independently the mobile application named Consilium without involvement of the physician.
Consilium
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.
Group C: app and physician
Patients use the mobile application named Consilium in collaboration with the physician.
Consilium
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.
Interventions
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Consilium
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years old and older
* German speaking
* written informed consent
* beginning of intravenous chemotherapy in the breast care center
* diagnosis breast cancer
* personal smartphone (own device)
18 Years
FEMALE
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Andreas Trojan, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Zurich, Clinical Pharmacology and Toxicology
Locations
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University Hospital Zurich, Clinical Pharmacology and Toxicology
Zurich, , Switzerland
Countries
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References
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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.
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.
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.
Other Identifiers
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PatAPP1, Version 1.3
Identifier Type: -
Identifier Source: org_study_id