Randomized Controlled Single-blind Trial to Evaluate the Mobile Tracking of Symptoms in Ambulatory Breast Cancer Patients

Conditions

Breast Cancer

Brief summary

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. * Trial with medical device

Andreas Trojan, Sven Roth, Reinhard Zenhäusern, Yannick Kadvany, Christian Jackisch et al. (7 authors)

Cancer Research2024-05-02

10.1158/1538-7445.sabcs23-po3-17-04

Impact of Electronic Patient-Reported Outcomes on Unplanned Consultations and Hospitalizations in Patients With Cancer Undergoing Systemic Therapy: Results of a Patient-Reported Outcome Study Compared With Matched Retrospective Data

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JMIR Formative Research2024-03-073 citations

10.2196/55917

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

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JMIR Cancer2024-02-272 citations

10.2196/54178

Effect of Collaborative Review of Electronic Patient-Reported Outcomes for Shared Reporting in Breast Cancer Patients: Descriptive Comparative Study

Andreas Trojan, B Bättig, Meinrad Mannhart, Burkhardt Seifert, Mathis Brauchbar et al. (6 authors)

JMIR Cancer2021-02-1812 citations

10.2196/26950

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial

Marco Egbring, Elmira Far, Małgorzata Roos, Michael Dietrich, Mathis Brauchbar et al. (7 authors)

Journal of Medical Internet Research2016-09-06107 citations

10.2196/jmir.6414

Interventions

DEVICEConsilium

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* female * 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)

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of reported Adverse Events	5-6 weeks for each patient	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.
influence on patients subjective well-being	5-6 weeks for each patient	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.

Countries

Switzerland

Outcome results

None listed