NCT03578731

Brief 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 planed visits on site.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
3 countries

18 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2020

Completed
Last Updated

February 1, 2022

Status Verified

November 1, 2020

Enrollment Period

2.6 years

First QC Date

May 8, 2018

Last Update Submit

January 31, 2022

Conditions

TelemedicineeHealth

Keywords

APPePROelectronic patient reported outcome

Outcome Measures

Primary Outcomes (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

    12 weeks of treatment

Secondary Outcomes (6)

  • ePRO and therapy side effects

    12 weeks of treatment

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

    12 weeks of treatment

  • Unplanned consultations

    12 weeks of treatment

  • Hospital days

    12 weeks of treatment

  • Patient characteristics for discontinued use of mobile monitoring

    12 weeks of treatment

  • +1 more secondary outcomes

Study Arms (1)

Consilium-APP

Patients with oncological, medical treatment for breast cancer, colon cancer, prostate cancer, lung cancer or hematological malignancies.

Device: app

Interventions

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

Consilium-APP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

LKH Feldkirch, Innere Medizin II

Feldkirch, 6807, Austria

Location

Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Gynäkologie

Halle, 06120, Germany

Location

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

Lübeck, 23538, Germany

Location

Sana Klinikum Offenbach Abteilung Gynäkologie und Geburtshilfe

Offenbach, 63069, Germany

Location

OnkoZentrum Zürich AG

Zurich, Canton of Zurich, 8038, Switzerland

Location

Kantonsspital Aarau

Aarau, 5000, Switzerland

Location

Tumor Zentrum Aarau - Hirslanden Medical Center

Aarau, 5000, Switzerland

Location

Onkologie Praxis Lindenhofspital

Bern, 3001, Switzerland

Location

PROLINDO - Lindenhofspital

Bern, 3001, Switzerland

Location

Oncocare Klinik Engeried

Bern, 3012, Switzerland

Location

TUCARE

Bülach, 8180, Switzerland

Location

Onko-Hämatologisches Zentrum Zug

Cham, 6330, Switzerland

Location

Kantonsspital Baselland

Liestal, 4410, Switzerland

Location

Limmattal Spital

Schlieren, 8952, Switzerland

Location

Onkologiepraxis Bellvue

Zurich, 8001, Switzerland

Location

Brust-Zentrum Zürich

Zurich, 8008, Switzerland

Location

OnkoZentrum Hirslanden

Zurich, 8032, Switzerland

Location

Universitätsspital Zürich, Klinik für Gynäkologie

Zurich, 8091, Switzerland

Location

Related Publications (4)

  • 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.

    PMID: 38710048DERIVED

  • 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.

    PMID: 38573759DERIVED

  • 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.

    PMID: 34383675DERIVED

  • 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.

    PMID: 33729162DERIVED

Study Officials

  • Andreas Trojan, Prof. Dr. med.

    OnkoZentrum Zürich AG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2018

First Posted

July 6, 2018

Study Start

March 5, 2018

Primary Completion

October 10, 2020

Study Completion

October 10, 2020

Last Updated

February 1, 2022

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR
Time Frame
2020/2021
More information

Locations

AU(1)CH(14)DE(3)