Breast CancerPatAPP1NCT02004496
Randomized Controlled Single-blind Trial to Evaluate the Mobile Tracking of Symptoms in Ambulatory Breast Cancer Patients
A study testing Consilium in people with Breast Cancer, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Consilium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Clinical Pharmacology and Toxicology
Zurich
About this study
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.
Read more
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
- Conditions
- Breast Cancer
- Being tested
- Consilium
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConsiliumDevice
Also called mobile application
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 group | Role | What they receive |
|---|---|---|
| Group A: no app | No intervention | no use of an mobile application while treatment |
| Group B: only app | Active comparator | Patients, who use independently the mobile application named Consilium without involvement of the physician. Receives: Device: Consilium |
| Group C: app and physician | Active comparator | Patients use the mobile application named Consilium in collaboration with the physician. Receives: Device: Consilium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of reported Adverse Events
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.
Measured: 5-6 weeks for each patient
influence on patients subjective well-being
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.
Measured: 5-6 weeks for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Termination due to relevant update of the operation system. Adaption of the application was not foreseen in the intervention study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Trojan, MD, Principal investigator, University Hospital Zurich, Clinical Pharmacology and Toxicology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004496
- Sponsor's protocol ID
- PatAPP1, Version 1.3
- Acronym
- PatAPP1
- Status last verified
- Dec 2015
- First submitted
- 25 Nov 2013
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Trojan A, Roth S, Atassi Z, Kiessling M, Zenhaeusern R, Kadvany Y, Schumacher J, Kullak-Ublick GA, Aapro M, Eniu A. 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. JMIR Cancer. 2024 Apr 4;10:e54178. doi: 10.2196/54178.
PubMed 38573759Trojan 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.
PubMed 33729162Egbring 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.
PubMed 27601354
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Single-blind Trial to Evaluate the Mobile Tracking of Symptoms in Ambulatory Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02004496
- Acronym / sponsor ID
- PatAPP1 / PatAPP1, Version 1.3
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination due to relevant update of the operation system. Adaption of the application was not foreseen in the intervention study.
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: no app | No intervention | –no use of an mobile application while treatment |
| Group B: only app | Active comparator | Device: ConsiliumPatients, who use independently the mobile application named Consilium without involvement of the physician. |
| Group C: app and physician | Active comparator | Device: ConsiliumPatients use the mobile application named Consilium in collaboration with the physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- female
- 18 years old and older
- German speaking
- written informed consent
- beginning of intravenous chemotherapy in the breast care center
Key exclusion criteria (1 listed)
- patients who did not meet the inclusion criteria or if compliance could be questioned, e.g. due to a psychiatric illness or personal life.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConsiliumAlso: mobile applicationPatients 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. | Device | Group B: only app, Group C: app and physician |
Primary outcome
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.
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.
Results and safety
The study was stopped early (reason given: Termination due to relevant update of the operation system. Adaption of the application was not foreseen in the intervention study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Derived from this study: PubMed 38573759Trojan A, Roth S, Atassi Z, Kiessling M, Zenhaeusern R, Kadvany Y, Schumacher J, Kullak-Ublick GA, Aapro M, Eniu A. 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. JMIR Cancer. 2024 Apr 4;10:e54178. doi: 10.2196/54178.
- Derived from this study: PubMed 33729162Trojan 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.
- Derived from this study: PubMed 27601354Egbring 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Trojan, MD principal investigator
University Hospital Zurich, Clinical Pharmacology and Toxicology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consilium in people with Breast Cancer, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Termination due to relevant update of the operation system. Adaption of the application was not foreseen in the intervention study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of reported Adverse Events (time frame: 5-6 weeks for each patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02004496, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.