Clinical trial NCT04386629: Health Economy Register
Official title: Evaluation of CANKADO in Breast Cancer Patients in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Lead sponsor: Cankado GmbH
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2020-05-13
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under medical treatment for breast cancer with access to CANKADO will be included in the analysis. This study will take place in at least 10 German centers with CANKADO access / participation representatively distributed in Germany.

Brief summary: In breast oncology, the increasing number of oral and intravenous drug therapies pose great challenges for patient management. Numerous studies demonstrate that well-informed patients develop higher confidence in their treatment and a greater sense of disease control, resulting in increased adherence and persistence as well as potentially better outcome. The electronic Patient Reported Outcome (ePRO) tool CANKADO is designed to help oncologists to fill the gap between good, personalized care and a time and resource-saving treatment for cancer patients. CANKADO helps patients and their physicians regarding therapy management by a standardized documentation procedure and, if needed, direct feedback to patients by the integrated Pro-React system. GeRA includes patients undergoing systemic therapy for breast cancer with access to CANKADO. The trial is based on questionnaires that are answered by patients via the CANKADO Patient App. Primary objective is to gain knowledge on the health economic impact of CANKADO resource utilization in breast cancer care including the evaluation of physicians' time and patient experience.


Eligibility criteria: Inclusion Criteria:

* Men and women with breast cancer
* Ongoing medical drug treatment
* 18 years or older
* CANKADO account

Exclusion Criteria:

* Lack of consent to study participation or lack of patient's ability to stuconsent

Primary outcomes:
measure: Occasion of consultation
timeFrame: 3 months
measure: Frequency of consultation
timeFrame: 3 months
measure: Duration of consultation
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life (QoL): Quality of Life Questionnaire (FACT-B)
timeFrame: 3 months
measure: Estimate usage satisfaction of healthcare professionals: minutes
timeFrame: 3 months
measure: Age
timeFrame: 3 months
measure: Gender
timeFrame: 3 months
measure: Grade of education
timeFrame: 3 months
measure: Number of inhabitants in hometown
timeFrame: 3 months
measure: German home state
timeFrame: 3 months
measure: Location of treatment
timeFrame: 3 months
measure: Year of primary brest cancer diagnosis
timeFrame: 3 months
measure: Radiotherapy treatment of patient
timeFrame: 3 months
measure: Oral cancer treatment of patient
timeFrame: 3 months
measure: Treatment of patient with osteopretectics
timeFrame: 3 months
measure: Treatment of patient against high blood pressure
timeFrame: 3 months
measure: Treatment of patient against diabetes
timeFrame: 3 months
measure: Treatment of patient against asthma
timeFrame: 3 months
measure: employment status of patient
timeFrame: 3 months
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Hämato-onkologischer Studienkreis am Klinikum Aschaffenburg
city: Cologne
country: Germany
facility: Kliniken der Stadt Köln - Krankenhaus Holweide, Brustzentrum
city: Essen
country: Germany
facility: Kliniken Essen Mitte
city: Frankfurt
country: Germany
facility: Onkology Bethanien Frankfurt
city: Hamburg
country: Germany
facility: Mammazentrum Hamburg Am Krankenhaus Jerusalem
city: Mainz
country: Germany
facility: University Hospital
city: Mannheim
country: Germany
facility: University Hospital
city: München
country: Germany
facility: University Hospital
city: Neuss
country: Germany
facility: Johanna Etienne Krankenhaus
city: Troisdorf
country: Germany
facility: Praxisnetzwerk Hämatologie/ intern. Onkologie
Study officials:
affiliation: Cankado GmbH
name: Timo Schinköthe, PhD
role: STUDY_DIRECTOR
References: