Randomized Controlled Single-blind Trial to Evaluate the Mobile Tracking of Symptoms in Ambulatory Breast Cancer Patients (PatAPP1)

• ClinicalTrials.gov Identifier: NCT02004496
• Recruitment Status: Terminated
• First Posted: December 9, 2013
• Last Update Posted: December 10, 2015
• Sponsor: University of Zurich
• Information provided by (Responsible Party): University of Zurich

Study Description

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

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Device: Consilium	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 139 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Study Start Date: December 2013
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: July 2015

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Group A: no app; no use of an mobile application while treatment
Active Comparator: Group B: only app; Patients, who use independently the mobile application named Consilium without involvement of the physician.	Device: 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 Name: mobile application
Active Comparator: Group C: app and physician; Patients use the mobile application named Consilium in collaboration with the physician.	Device: 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 Name: mobile application

Outcome Measures

Primary Outcome Measures :

1. Number of reported Adverse Events [ Time Frame: 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.

2. influence on patients subjective well-being [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Switzerland

University Hospital Zurich, Clinical Pharmacology and Toxicology

Zurich, Switzerland

Sponsors and Collaborators

University of Zurich

Investigators

• Principal Investigator: Andreas Trojan, MD; University Hospital Zurich, Clinical Pharmacology and Toxicology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT02004496
• Other Study ID Numbers: PatAPP1, Version 1.3
• First Posted: December 9, 2013
• Last Update Posted: December 10, 2015
• Last Verified: December 2015

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases