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

University of Zurich (UZH)

Status: Terminated

Conditions: Breast Cancer

Treatments: Device: Consilium

Study type: Interventional

Funder types: Other

Identifiers

NCT02004496

PatAPP1, Version 1.3

Details and patient eligibility

About

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

Enrollment: 139 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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139 participants in 3 patient groups

Group A: no app

No Intervention group

Description:

no use of an mobile application while treatment

Group B: only app

Active Comparator group

Description:

Patients, who use independently the mobile application named Consilium without involvement of the physician.

Treatment:

Device: Consilium

Group C: app and physician

Active Comparator group

Description:

Patients use the mobile application named Consilium in collaboration with the physician.

Treatment:

Device: Consilium