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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
Sponsor:
Collaborator:
Stiftung Swiss Tumor Institut
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Telemedicine eHealth Device: app

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

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Study Type : Observational
Actual Enrollment : 224 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Consilium-APP
Patients with oncological, medical treatment for breast cancer, colon cancer, prostate cancer, lung cancer or hematological malignancies.
Device: app

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





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Unplanned consultations [ Time Frame: 12 weeks of treatment ]
    Number and nature of unplanned consultations, (consultation vs. emergency hospitalizations)

  4. Hospital days [ Time Frame: 12 weeks of treatment ]
    Number of days in the hospital during for each event (≤2 days or > 2 days)

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with the most common types of cancer in the treatment center will be included: Breast, Colon, Prostate, Lung, Hematological malignancies
Criteria

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.

Information from the National Library of Medicine

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


Locations
Show Show 18 study locations
Sponsors and Collaborators
OnkoZentrum Zürich AG
Stiftung Swiss Tumor Institut
Investigators
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Principal Investigator: Andreas Trojan, Prof. Dr. med. OnkoZentrum Zürich AG
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: OnkoZentrum Zürich AG
ClinicalTrials.gov Identifier: NCT03578731    
Other Study ID Numbers: 2017-02028
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 2020/2021
URL: https://www.clinicaltrials.gov/ct2/search

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by OnkoZentrum Zürich AG:
APP