Efficacy of the "Consilium" Smartphone App for Detecting Symptoms and Treatment Side Effects in Cancer Patients (APP-2)
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|ClinicalTrials.gov Identifier: NCT03578731|
Recruitment Status : Terminated (Mainly due to insufficient recruitment)
First Posted : July 6, 2018
Last Update Posted : November 12, 2020
|Condition or disease||Intervention/treatment|
|Telemedicine eHealth||Device: app|
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
|Study Type :||Observational|
|Actual Enrollment :||224 participants|
|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|
|Actual Study Start Date :||March 5, 2018|
|Actual Primary Completion Date :||October 10, 2020|
|Actual Study Completion Date :||October 10, 2020|
Patients with oncological, medical treatment for breast cancer, colon cancer, prostate cancer, lung cancer or hematological malignancies.
The app is used to record the study parameters for a period of 90 days.
The following measures are used for data collection:
After completion of the study patients will be questioned according to:
• Usability and usefulness of the Smartphone app
- Level of agreement [ Time Frame: 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
- ePRO and therapy side effects [ Time Frame: 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
- Rating of different qualities of electronically reported symptoms in out-patient settings [ Time Frame: 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 [ Time Frame: 12 weeks of treatment ]Number and nature of unplanned consultations, (consultation vs. emergency hospitalizations)
- Hospital days [ Time Frame: 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 [ Time Frame: 12 weeks of treatment ]Assessment of patients' characteristics for a discontinuation of the use of the mobile monitoring
- Usability and usefulness of smartphone app [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578731
|Principal Investigator:||Andreas Trojan, Prof. Dr. med.||OnkoZentrum Zürich AG|