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

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Device: Consilium

• Registration Number: NCT02004496
• Lead Sponsor: University of Zurich

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-11-25
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 139

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: only app	Consilium	Patients, who use independently the mobile application named Consilium without involvement of the physician.
Group C: app and physician	Consilium	Patients use the mobile application named Consilium in collaboration with the physician.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital Zurich, Clinical Pharmacology and Toxicology; 🇨🇭 Zurich, Switzerland