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

NCT ID: NCT03578731

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 224 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-05
• Study Completion Date: 2020-10-10

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

Conditions

Telemedicine; eHealth

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Consilium-APP

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

app

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stiftung Swiss Tumor Institute

OTHER

Sponsor Role: collaborator

OnkoZentrum Zürich AG

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Trojan, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

OnkoZentrum Zürich AG

Locations

LKH Feldkirch, Innere Medizin II

Feldkirch, , Austria

Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Gynäkologie

Halle, , Germany

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

Lübeck, , Germany

Sana Klinikum Offenbach Abteilung Gynäkologie und Geburtshilfe

Offenbach, , Germany

OnkoZentrum Zürich AG

Zurich, Canton of Zurich, Switzerland

Kantonsspital Aarau

Aarau, , Switzerland

Tumor Zentrum Aarau - Hirslanden Medical Center

Aarau, , Switzerland

Onkologie Praxis Lindenhofspital

Bern, , Switzerland

PROLINDO - Lindenhofspital

Bern, , Switzerland

Oncocare Klinik Engeried

Bern, , Switzerland

TUCARE

Bülach, , Switzerland

Onko-Hämatologisches Zentrum Zug

Cham, , Switzerland

Kantonsspital Baselland

Liestal, , Switzerland

Limmattal Spital

Schlieren, , Switzerland

Onkologiepraxis Bellvue

Zurich, , Switzerland

Brust-Zentrum Zürich

Zurich, , Switzerland

OnkoZentrum Hirslanden

Zurich, , Switzerland

Universitätsspital Zürich, Klinik für Gynäkologie

Zurich, , Switzerland

Countries

Austria; Germany; Switzerland

References

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.

Reference Type: DERIVED

PMID: 38710048 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38573759 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34383675 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33729162 (View on PubMed)

Other Identifiers

2017-02028

Identifier Type: -

Identifier Source: org_study_id