Health Economy Register (GeRA)

Evaluation of CANKADO in Breast Cancer Patients in Germany

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms

• Study Type: Observational
• Enrollment (Actual): 219

Contacts and Locations

Study Locations

• Germany
  • Aschaffenburg, Germany, 63739
    • Hämato-onkologischer Studienkreis am Klinikum Aschaffenburg
  • Cologne, Germany, 51067
    • Kliniken der Stadt Köln - Krankenhaus Holweide, Brustzentrum
  • Essen, Germany, 45136
    • Kliniken Essen Mitte
  • Frankfurt, Germany, 60389
    • Onkology Bethanien Frankfurt
  • Hamburg, Germany, 20357
    • Mammazentrum Hamburg am Krankenhaus Jerusalem
  • Mainz, Germany, 55131
    • University Hospital
  • Mannheim, Germany, 68167
    • University Hospital
  • München, Germany, 80377
    • University Hospital
  • Neuss, Germany, 41462
    • Johanna Etienne Krankenhaus
  • Troisdorf, Germany, 53840
    • Praxisnetzwerk Hämatologie/ intern. Onkologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Age	Assessed in years	3 months
Gender	Assessed as male/female	3 months
Grade of education	Assessed as following options: secondary modern school, secondary school, abitur, university degree, promotion	3 months
Number of inhabitants in hometown		3 months
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
Location of treatment	Assessed as: university hospital, hospital, haemato-oncologist, gynaecologic oncologist	3 months
Year of primary brest cancer diagnosis		3 months
Radiotherapy treatment of patient	assessed as: yes/no	3 months
Oral cancer treatment of patient	assessed as: yes/no	3 months
Treatment of patient with osteopretectics	assessed as: yes/no	3 months
Treatment of patient against high blood pressure	assessed as: yes/no	3 months
Treatment of patient against diabetes	assessed as: yes/no	3 months
Treatment of patient against asthma	assessed as: yes/no	3 months
employment status of patient	assessed as : employed, not employed, retirement	3 months

Collaborators and Investigators

• Sponsor: Cankado GmbH
• Collaborators: Amgen
• Investigators: Study Director: Timo Schinköthe, PhD, Cankado GmbH

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 20180349