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

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Trial Identification

Brief Title: 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 ID: NCT03578731

Interventions

app

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

LKH Feldkirch, Innere Medizin II, Feldkirch, , Austria

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, , Germany

OnkoZentrum Zürich AG, Zürich, 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, Zürich, , Switzerland

Brust-Zentrum Zürich, Zürich, , Switzerland

OnkoZentrum Hirslanden, Zürich, , Switzerland

Universitätsspital Zürich, Klinik für Gynäkologie, Zürich, , Switzerland

Contact Details

Name: Andreas Trojan, Prof. Dr. med.

Affiliation: OnkoZentrum Zürich AG

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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