Clinical trial NCT03578731: Efficacy of the "Consilium" Smartphone App for Detecting Symptoms and Treatment Side Effects in Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Telemedicine
eHealth
Keywords: APP
ePRO
electronic patient reported outcome
Lead sponsor: OnkoZentrum Zürich AG
Sponsor class: OTHER
Collaborators: name: Stiftung Swiss Tumor Institute
First posted: 2018-07-06
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with the most common types of cancer in the treatment center will be included: Breast, Colon, Prostate, Lung, Hematological malignancies

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Level of agreement
timeFrame: 12 weeks of treatment
Secondary outcomes:
measure: ePRO and therapy side effects
timeFrame: 12 weeks of treatment
measure: Rating of different qualities of electronically reported symptoms in out-patient settings
timeFrame: 12 weeks of treatment
measure: Unplanned consultations
timeFrame: 12 weeks of treatment
measure: Hospital days
timeFrame: 12 weeks of treatment
measure: Patient characteristics for discontinued use of mobile monitoring
timeFrame: 12 weeks of treatment
measure: Usability and usefulness of smartphone app
timeFrame: 12 weeks of treatment
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: LKH Feldkirch, Innere Medizin II
city: Halle / Saale
country: Germany
facility: Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Gynäkologie
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Klinik für Frauenheilkunde und Geburtshilfe (Gynäkologie)
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach Abteilung Gynäkologie und Geburtshilfe
city: Zürich
country: Switzerland
facility: OnkoZentrum Zürich AG
state: Zurich
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Aarau
country: Switzerland
facility: Tumor Zentrum Aarau - Hirslanden Medical Center
city: Bern
country: Switzerland
facility: Onkologie Praxis Lindenhofspital
city: Bern
country: Switzerland
facility: PROLINDO - Lindenhofspital
city: Bern
country: Switzerland
facility: Oncocare Klinik Engeried
city: Bülach
country: Switzerland
facility: TUCARE
city: Cham
country: Switzerland
facility: Onko-Hämatologisches Zentrum Zug
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
city: Schlieren
country: Switzerland
facility: Limmattal Spital
city: Zürich
country: Switzerland
facility: Onkologiepraxis Bellvue
city: Zürich
country: Switzerland
facility: Brust-Zentrum Zürich
city: Zürich
country: Switzerland
facility: OnkoZentrum Hirslanden
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich, Klinik für Gynäkologie
Study officials:
affiliation: OnkoZentrum Zürich AG
name: Andreas Trojan, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.