Health Economy Register

Breast Neoplasms Clinical Trial

— GeRA  

Official title:

Evaluation of CANKADO in Breast Cancer Patients in Germany

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386629
• Other study ID #: 20180349
• Status: Completed
• Start date: July 5, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Cankado Service GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
Germany	Hämato-onkologischer Studienkreis am Klinikum Aschaffenburg	Aschaffenburg
Germany	Kliniken der Stadt Köln - Krankenhaus Holweide, Brustzentrum	Cologne
Germany	Kliniken Essen Mitte	Essen
Germany	Onkology Bethanien Frankfurt	Frankfurt
Germany	Mammazentrum Hamburg Am Krankenhaus Jerusalem	Hamburg
Germany	University Hospital	Mainz
Germany	University Hospital	Mannheim
Germany	University Hospital	München
Germany	Johanna Etienne Krankenhaus	Neuss
Germany	Praxisnetzwerk Hämatologie/ intern. Onkologie	Troisdorf

Sponsors (2)

Lead Sponsor	Collaborator
Cankado Service GmbH	Amgen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occasion of consultation	To obtain the information on the health economic impact of CANKADO resource utilization patients will be asked to fill in a questionnaire containing a question about the occasion of consultation.	3 months
Primary	Frequency of consultation	To obtain the information on the health economic impact of CANKADO resource utilization patients will be asked to fill in a questionnaire containing a question about the frequency of consultation.	3 months
Primary	Duration of consultation	To obtain the information on the health economic impact of CANKADO resource utilization patients will be asked to fill in a questionnaire containing a question about the duration of consultation. Also, the time spent for travelling and for the appointment is included here.	3 months
Secondary	Quality of life (QoL): Quality of Life Questionnaire (FACT-B)	Quality of life (QoL) was assessed as part of the Quality of Life Questionnaire (FACT-B) as the subjective feeling of the patient	3 months
Secondary	Estimate usage satisfaction of healthcare professionals: minutes	The usage satisfaction of healthcare professionals was evaluated by assessing the impact on workload of CANKADO assessed in minutes.	3 months
Secondary	Age	Assessed in years	3 months
Secondary	Gender	Assessed as male/female	3 months
Secondary	Grade of education	Assessed as following options: secondary modern school, secondary school, abitur, university degree, promotion	3 months
Secondary	Number of inhabitants in hometown		3 months
Secondary	German home state	Assessed as: Baden-Württemberg, Bayern, Berlin, Brandenburg, Bremen, Hamburg, Hessen, Mecklenburg-Vorpommern, Niedersachsen, Nordrhein-Westfalen, Rheinland-Pfalz, Saarland, Sachsen, Sachsen-Anhalt, Schleswig-Holstein, Thüringen	3 months
Secondary	Location of treatment	Assessed as: university hospital, hospital, haemato-oncologist, gynaecologic oncologist	3 months
Secondary	Year of primary brest cancer diagnosis		3 months
Secondary	Radiotherapy treatment of patient	assessed as: yes/no	3 months
Secondary	Oral cancer treatment of patient	assessed as: yes/no	3 months
Secondary	Treatment of patient with osteopretectics	assessed as: yes/no	3 months
Secondary	Treatment of patient against high blood pressure	assessed as: yes/no	3 months
Secondary	Treatment of patient against diabetes	assessed as: yes/no	3 months
Secondary	Treatment of patient against asthma	assessed as: yes/no	3 months
Secondary	employment status of patient	assessed as : employed, not employed, retirement	3 months