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

Telemedicine Clinical Trial

— APP-2  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03578731
• Other study ID #: 2017-02028
• Status: Terminated
• Start date: March 5, 2018
• Est. completion date: October 10, 2020

Study information

• Verified date: November 2020
• Source: OnkoZentrum Zürich AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 planed visits on site.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 224
• Est. completion date: October 10, 2020
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• eHealth
• Telemedicine

Intervention

Device:
• app
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

Locations

Country	Name	City	State
Austria	LKH Feldkirch, Innere Medizin II	Feldkirch
Germany	Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Gynäkologie	Halle / Saale
Germany	Universitätsklinikum Schleswig-Holstein, Klinik für Frauenheilkunde und Geburtshilfe (Gynäkologie)	Lübeck
Germany	Sana Klinikum Offenbach Abteilung Gynäkologie und Geburtshilfe	Offenbach
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	Tumor Zentrum Aarau - Hirslanden Medical Center	Aarau
Switzerland	Oncocare Klinik Engeried	Bern
Switzerland	Onkologie Praxis Lindenhofspital	Bern
Switzerland	PROLINDO - Lindenhofspital	Bern
Switzerland	TUCARE	Bülach
Switzerland	Onko-Hämatologisches Zentrum Zug	Cham
Switzerland	Kantonsspital Baselland	Liestal
Switzerland	Limmattal Spital	Schlieren
Switzerland	Brust-Zentrum Zürich	Zürich
Switzerland	Onkologiepraxis Bellvue	Zürich
Switzerland	OnkoZentrum Hirslanden	Zürich
Switzerland	OnkoZentrum Zürich AG	Zürich	Zurich
Switzerland	Universitätsspital Zürich, Klinik für Gynäkologie	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
OnkoZentrum Zürich AG	Stiftung Swiss Tumor Institut

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of agreement	Level of agreement ? 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	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	12 weeks of treatment
Secondary	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	12 weeks of treatment
Secondary	Unplanned consultations	Number and nature of unplanned consultations, (consultation vs. emergency hospitalizations)	12 weeks of treatment
Secondary	Hospital days	Number of days in the hospital during for each event (=2 days or > 2 days)	12 weeks of treatment
Secondary	Patient characteristics for discontinued use of mobile monitoring	Assessment of patients' characteristics for a discontinuation of the use of the mobile monitoring	12 weeks of treatment
Secondary	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	12 weeks of treatment