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.
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
224
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
LKH Feldkirch, Innere Medizin II
Feldkirch, Austria
Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Gynäkologie
Halle, Germany
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
Time frame: 12 weeks of treatment
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
Time frame: 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
Time frame: 12 weeks of treatment
Unplanned consultations
Number and nature of unplanned consultations, (consultation vs. emergency hospitalizations)
Time frame: 12 weeks of treatment
Hospital days
Number of days in the hospital during for each event (≤2 days or \> 2 days)
Time frame: 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
Time frame: 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
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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
...and 8 more locations
Time frame: 12 weeks of treatment