Efficacy of the "Consilium" Smartphone App for Detecting Symptoms and Treatment Side Effects in Cancer Patients
- Conditions
- TelemedicineeHealth
- Registration Number
- NCT03578731
- Lead Sponsor
- OnkoZentrum Zürich AG
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 224
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Level of agreement 12 weeks of treatment 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
- Secondary Outcome Measures
Name Time Method ePRO and therapy side effects 12 weeks of treatment Assessment of the number, characteristics and intensity of electronically reported symptoms and therapy side effects during the first three months of therapy
Usability and usefulness of smartphone app 12 weeks of treatment 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
Rating of different qualities of electronically reported symptoms in out-patient settings 12 weeks of treatment 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
Unplanned consultations 12 weeks of treatment Number and nature of unplanned consultations, (consultation vs. emergency hospitalizations)
Hospital days 12 weeks of treatment Number of days in the hospital during for each event (≤2 days or \> 2 days)
Patient characteristics for discontinued use of mobile monitoring 12 weeks of treatment Assessment of patients' characteristics for a discontinuation of the use of the mobile monitoring
Trial Locations
- Locations (18)
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
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