Health Economy Register

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT04386629
• Lead Sponsor: Cankado GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-05
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-13
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of consultation	3 months	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.
Occasion of consultation	3 months	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.
Duration of consultation	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life (QoL): Quality of Life Questionnaire (FACT-B)	3 months	Quality of life (QoL) was assessed as part of the Quality of Life Questionnaire (FACT-B) as the subjective feeling of the patient
Estimate usage satisfaction of healthcare professionals: minutes	3 months	The usage satisfaction of healthcare professionals was evaluated by assessing the impact on workload of CANKADO assessed in minutes.
Age	3 months	Assessed in years
Gender	3 months	Assessed as male/female
Grade of education	3 months	Assessed as following options: secondary modern school, secondary school, abitur, university degree, promotion
Number of inhabitants in hometown	3 months
German home state	3 months	Assessed as: Baden-Württemberg, Bayern, Berlin, Brandenburg, Bremen, Hamburg, Hessen, Mecklenburg-Vorpommern, Niedersachsen, Nordrhein-Westfalen, Rheinland-Pfalz, Saarland, Sachsen, Sachsen-Anhalt, Schleswig-Holstein, Thüringen
Location of treatment	3 months	Assessed as: university hospital, hospital, haemato-oncologist, gynaecologic oncologist
Year of primary brest cancer diagnosis	3 months
Radiotherapy treatment of patient	3 months	assessed as: yes/no
Oral cancer treatment of patient	3 months	assessed as: yes/no
Treatment of patient with osteopretectics	3 months	assessed as: yes/no
Treatment of patient against high blood pressure	3 months	assessed as: yes/no
Treatment of patient against diabetes	3 months	assessed as: yes/no
Treatment of patient against asthma	3 months	assessed as: yes/no
employment status of patient	3 months	assessed as : employed, not employed, retirement

Trial Locations

Locations (8)

Onkology Bethanien Frankfurt; 🇩🇪 Frankfurt, Germany

Hämato-onkologischer Studienkreis am Klinikum Aschaffenburg; 🇩🇪 Aschaffenburg, Germany

Kliniken der Stadt Köln - Krankenhaus Holweide, Brustzentrum; 🇩🇪 Cologne, Germany

Kliniken Essen Mitte; 🇩🇪 Essen, Germany

Johanna Etienne Krankenhaus; 🇩🇪 Neuss, Germany

Praxisnetzwerk Hämatologie/ intern. Onkologie; 🇩🇪 Troisdorf, Germany

Mammazentrum Hamburg Am Krankenhaus Jerusalem; 🇩🇪 Hamburg, Germany

University Hospital; 🇩🇪 München, Germany