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

Study Overview
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Brief Summary
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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
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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: 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. 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. 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

Official Title
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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

Conditions
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Telemedicine, eHealth

Intervention / Treatment
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* Device: app


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Consilium-APP<br>Patients with oncological, medical treatment for breast cancer, colon cancer, prostate cancer, lung cancer or hematological malignancies. | Device: app<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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APP, ePRO, electronic patient reported outcome