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TelemedicineAPP-2NCT03578731

Efficacy of the "Consilium" Smartphone App for Detecting Symptoms and Treatment Side Effects in Cancer Patients

An observational study of Telemedicine and eHealth, run by OnkoZentrum Zürich AG at 18 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study investigates the influence of the use of a Smartphone App, on changes in general well-being and the occurrence of symptoms during a tumor therapy. With this documentation, medical professionals should be enabled to judge the influence of symptoms on quality of life during different time periods, between… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Telemedicine, eHealth
What is being tested?
app
Type of treatment
Medical device
How many people
224 participants
Where
18 sitesin 3 countries
Study dates
5 Mar 2018to 10 Oct 2020
Phase
Observational
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with the most common types of cancer in the treatment center will be included: Breast, Colon, Prostate, Lung, Hematological malignancies

Who may be able to join

  • Signed Informed Consent Form
  • Women or men aged ≥ 18 years
  • Patients with breast, colon, prostate, lung cancer or hemat. malignancies
  • Initiation or change of therapy for the types of cancer mentioned above
  • German speaking
  • Personal smartphone with iOS or Android system

Who cannot join

  • Patients whose compliance must be questioned, e.g. due to a psychological disorders or private life situation
  • Patients with insufficient knowledge of smartphone use.

Trial locations and contacts

18 sites in 3 countries.

18 sites in 3 countries

Switzerland14 sites

  • Kantonsspital Aarau

    Aarau, 5000

  • Tumor Zentrum Aarau - Hirslanden Medical Center

    Aarau, 5000

  • Onkologie Praxis Lindenhofspital

    Bern, 3001

  • PROLINDO - Lindenhofspital

    Bern, 3001

  • Oncocare Klinik Engeried

    Bern, 3012

  • TUCARE

    Bülach, 8180

  • Onko-Hämatologisches Zentrum Zug

    Cham, 6330

  • Kantonsspital Baselland

    Liestal, 4410

  • Limmattal Spital

    Schlieren, 8952

  • OnkoZentrum Zürich AG

    Zurich, Canton of Zurich, 8038

  • Onkologiepraxis Bellvue

    Zurich, 8001

  • Brust-Zentrum Zürich

    Zurich, 8008

  • OnkoZentrum Hirslanden

    Zurich, 8032

  • Universitätsspital Zürich, Klinik für Gynäkologie

    Zurich, 8091

Other trials in Switzerland

Germany3 sites

  • Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Gynäkologie

    Halle, 06120

  • Universitätsklinikum Schleswig-Holstein, Klinik für Frauenheilkunde und Geburtshilfe (Gynäkologie)

    Lübeck, 23538

  • Sana Klinikum Offenbach Abteilung Gynäkologie und Geburtshilfe

    Offenbach, 63069

Other trials in Germany

Austria1 site

  • LKH Feldkirch, Innere Medizin II

    Feldkirch, 6807

Other trials in Austria

About this study

Official title: Efficacy of the "Consilium" Smartphone App for Detecting Symptoms and Treatment Side Effects in Cancer Patients Depending on Form of Medication Application, Age and Outpatient Characteristics: Observational Study

The study investigates the influence of the use of a Smartphone App, on changes in general well-being and the occurrence of symptoms during a tumor therapy. With this documentation, medical professionals should be enabled to judge the influence of symptoms on quality of life during different time periods, between planed visits on site.

Read the detailed description

The study will examine the number, characteristics and intensity of electronically reported symptoms and therapy side effects depending on treatment and characteristics of patients with cancer of breast, colon, prostate, lung and hematological malignancies during a three-month period from the initiation of therapy. This period frequently represents the duration of a therapeutic regimen.

The level of agreement κ between the ECOG/CTCAE ratings by physicians at the time of the regular consultation, and the ratings derived from the daily PROs between consultations, will be analyzed in order to determine the reliability and utility of self-reported electronic symptom monitoring.

The purpose is to evaluate different qualities of symptoms self-reported electronically between consultations with respect to the course of treatment application, out-patient settings, gender and age. In particular, outpatients with frequent (weekly) consultations will be compared to patients with infrequent consultations (3-weekly or less frequent).

The study will also aim to identify the conditions and factors that might increase the likelihood of an unplanned consultation or emergency hospitalization.

In particular, the proposed study design and associated primary and secondary endpoints will enable us to test the following hypotheses:

  1. In patient groups with infrequent outpatient visits (3-weekly or less) as is determined by the treatment schedule, the level of agreement κ between ePRO-derived ECOG/CTCAE ratings and physician-derived ECOG/CTCAE ratings (at time of consultation) is at least as high as in patient groups with weekly visits for symptoms having occurred within the week before the visit. However, κ is expected lower in the group with infrequent visits for symptoms having occurred more than 2 weeks prior to consultation, due to higher fidelity of ePRO-derived ratings for long-ago symptoms.
  2. Regular visits of outpatients undergoing infusion therapy (as determined by the treatment schedule) do not significantly decrease the number of unplanned and emergency consultations necessary.
  3. Young female and older male patient groups report significantly more severe and worsening symptoms and side effects.

Patients with the most common types of cancer in the treatment center will be included:

Breast, Colon, Prostate, Lung, Hematological malignancies

Being tested
app
Keywords
APP, ePRO, electronic patient reported outcome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • appDevice

    The app is used to record the study parameters for a period of 90 days.

    The following measures are used for data collection:

    • Interview during regular consultation with doctor
    • Web-App for gathering doctors data
    • "Consilium" Smartphone App for gathering patient data During the course of care, the patient enters in a regular manner symptoms and treatment side effects in the Smartphone app. A continuous capture of the symptoms and treatment side effect is provided. If no entry is made within 3 days the patient is prompted to enter the data via a push message.
    • Well-being through a patient rating on a visual analog scale
    • Registration of symptoms and treatment side effects is done through the app

    After completion of the study patients will be questioned according to:

    • Usability and usefulness of the Smartphone app
Study groups in NCT03578731
Study groupRoleWhat they receive
Consilium-APPPatients with oncological, medical treatment for breast cancer, colon cancer, prostate cancer, lung cancer or hematological malignancies.
Receives: Device: app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of agreement

    Level of agreement κ with respect to categories of common toxicity criteria (ECOG/CTCAE) categories between ePRO recording and the treating physician at time of consultation

    Measured: 12 weeks of treatment

Secondary outcomes (6)

  1. ePRO and therapy side effects

    Assessment of the number, characteristics and intensity of electronically reported symptoms and therapy side effects during the first three months of therapy

    Measured: 12 weeks of treatment

  2. Rating of different qualities of electronically reported symptoms in out-patient settings

    Rating of different qualities of electronically reported symptoms in out-patient settings with respect to: course of treatment application (oral vs. infusion vs. radiation), treatment (systemic vs. local), gender and age

    Measured: 12 weeks of treatment

  3. Unplanned consultations

    Number and nature of unplanned consultations, (consultation vs. emergency hospitalizations)

    Measured: 12 weeks of treatment

  4. Hospital days

    Number of days in the hospital during for each event (≤2 days or > 2 days)

    Measured: 12 weeks of treatment

  5. Patient characteristics for discontinued use of mobile monitoring

    Assessment of patients' characteristics for a discontinuation of the use of the mobile monitoring

    Measured: 12 weeks of treatment

  6. Usability and usefulness of smartphone app

    Evaluation of the usability and usefulness of the smartphone app in the course of the treatment as rated by physician and patient after completion of the study

    Measured: 12 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2018
  2. Study start5 Mar 2018
  3. Primary completion10 Oct 2020
  4. Study completion10 Oct 2020

Why it stopped: Mainly due to insufficient recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03578731
Sponsor's protocol ID
2017-02028
Other IDs
2017
Acronym
APP-2
Status last verified
Nov 2020
First submitted
8 May 2018
Last updated
1 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Trojan A, Kuhne C, Kiessling M, Schumacher J, Drose S, Singer C, Jackisch C, Thomssen C, Kullak-Ublick GA. Impact of Electronic Patient-Reported Outcomes on Unplanned Consultations and Hospitalizations in Patients With Cancer Undergoing Systemic Therapy: Results of a Patient-Reported Outcome Study Compared With Matched Retrospective Data. JMIR Form Res. 2024 May 6;8:e55917. doi: 10.2196/55917.

    PubMed 38710048

  • 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 38573759

  • Trojan A, Leuthold N, Thomssen C, Rody A, Winder T, Jakob A, Egger C, Held U, Jackisch C. The Effect of Collaborative Reviews of Electronic Patient-Reported Outcomes on the Congruence of Patient- and Clinician-Reported Toxicity in Cancer Patients Receiving Systemic Therapy: Prospective, Multicenter, Observational Clinical Trial. J Med Internet Res. 2021 Aug 5;23(8):e29271. doi: 10.2196/29271.

    PubMed 34383675

  • 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.

    PubMed 33729162

Questions about this trial

What is this clinical trial studying?

An observational study of Telemedicine and eHealth, run by OnkoZentrum Zürich AG at 18 sites in 3 countries.

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 6 inclusion and 2 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 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Switzerland, Germany, Austria. 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: Mainly due to insufficient recruitment). 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?

Level of agreement (time frame: 12 weeks of treatment). 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 NCT03578731, which also lists 4 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 1 Feb 2022.

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