Health Economy Register

NCT ID: NCT04386629

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 219 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-05
• Study Completion Date: 2020-12-31

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.

Conditions

Breast Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Cankado GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timo Schinköthe, PhD

Role: STUDY_DIRECTOR

Cankado GmbH

Locations

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, , Germany

Countries

Germany

Other Identifiers

20180349

Identifier Type: -

Identifier Source: org_study_id