Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02004496
Recruitment Status : Terminated (Termination due to relevant update of the operation system. Adaption of the application was not foreseen in the intervention study.)
First Posted : December 9, 2013
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
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

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

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004496


Locations
Layout table for location information
Switzerland
University Hospital Zurich, Clinical Pharmacology and Toxicology
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Layout table for investigator information
Principal Investigator: Andreas Trojan, MD University Hospital Zurich, Clinical Pharmacology and Toxicology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02004496     History of Changes
Other Study ID Numbers: PatAPP1, Version 1.3
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases