Efficacy of the "Consilium" Smartphone App for Detecting Symptoms and Treatment Side Effects in Cancer Patients (APP-2)

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.

Study Overview

• Status: Terminated
• Conditions: Telemedicine; eHealth
• Intervention / Treatment: Device: app

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

• Study Type: Observational
• Enrollment (Actual): 224

Contacts and Locations

Study Locations

• Austria
  • Feldkirch, Austria, 6807
    • LKH Feldkirch, Innere Medizin II
• Germany
  • Halle / Saale, Germany, 06120
    • Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Gynäkologie
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein, Klinik für Frauenheilkunde und Geburtshilfe (Gynäkologie)
  • Offenbach, Germany, 63069
    • Sana Klinikum Offenbach Abteilung Gynäkologie und Geburtshilfe
• Switzerland
  • Aarau, Switzerland, 5000
    • Kantonsspital Aarau
  • Aarau, Switzerland, 5000
    • Tumor Zentrum Aarau - Hirslanden Medical Center
  • Bern, Switzerland, 3001
    • Onkologie Praxis Lindenhofspital
  • Bern, Switzerland, 3001
    • PROLINDO - Lindenhofspital
  • Bern, Switzerland, 3012
    • Oncocare Klinik Engeried
  • Bülach, Switzerland, 8180
    • TUCARE
  • Cham, Switzerland, 6330
    • Onko-Hämatologisches Zentrum Zug
  • Liestal, Switzerland, 4410
    • Kantonsspital Baselland
  • Schlieren, Switzerland, 8952
    • Limmattal Spital
  • Zürich, Switzerland, 8001
    • Onkologiepraxis Bellvue
  • Zürich, Switzerland, 8008
    • Brust-Zentrum Zurich
  • Zürich, Switzerland, 8032
    • Onkozentrum Hirslanden
  • Zürich, Switzerland, 8091
    • Universitätsspital Zürich, Klinik für Gynäkologie
  • Zurich
    • Zürich, Zurich, Switzerland, 8038
      • OnkoZentrum Zürich AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Unplanned consultations	Number and nature of unplanned consultations, (consultation vs. emergency hospitalizations)	12 weeks of treatment
Hospital days	Number of days in the hospital during for each event (≤2 days or > 2 days)	12 weeks of treatment
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
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

Collaborators and Investigators

• Sponsor: OnkoZentrum Zürich AG
• Collaborators: Stiftung Swiss Tumor Institute
• Investigators: Principal Investigator: Andreas Trojan, Prof. Dr. med., OnkoZentrum Zürich AG

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2018
• Primary Completion (ACTUAL): October 10, 2020
• Study Completion (ACTUAL): October 10, 2020

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: July 4, 2018
• First Posted (ACTUAL): July 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: ePRO; APP; electronic patient reported outcome
• Other Study ID Numbers: 2017-02028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 2020/2021
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No