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Health Economy Register

Evaluation of CANKADO in Breast Cancer Patients in Germany

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04386629
Acronym
GeRA
Enrollment
219
Registered
2020-05-13
Start date
2019-07-05
Completion date
2020-12-31
Last updated
2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

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.

Interventions

None listed

Sponsors

Amgen
CollaboratorINDUSTRY
Cankado GmbH
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occasion of consultation3 monthsTo 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.
Frequency of consultation3 monthsTo 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.
Duration of consultation3 monthsTo 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

MeasureTime frameDescription
Gender3 monthsAssessed as male/female
Grade of education3 monthsAssessed as following options: secondary modern school, secondary school, abitur, university degree, promotion
Number of inhabitants in hometown3 months
German home state3 monthsAssessed 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 treatment3 monthsAssessed as: university hospital, hospital, haemato-oncologist, gynaecologic oncologist
Year of primary brest cancer diagnosis3 months
Quality of life (QoL): Quality of Life Questionnaire (FACT-B)3 monthsQuality of life (QoL) was assessed as part of the Quality of Life Questionnaire (FACT-B) as the subjective feeling of the patient
Oral cancer treatment of patient3 monthsassessed as: yes/no
Treatment of patient with osteopretectics3 monthsassessed as: yes/no
Treatment of patient against high blood pressure3 monthsassessed as: yes/no
Treatment of patient against diabetes3 monthsassessed as: yes/no
Treatment of patient against asthma3 monthsassessed as: yes/no
employment status of patient3 monthsassessed as : employed, not employed, retirement
Radiotherapy treatment of patient3 monthsassessed as: yes/no
Estimate usage satisfaction of healthcare professionals: minutes3 monthsThe usage satisfaction of healthcare professionals was evaluated by assessing the impact on workload of CANKADO assessed in minutes.
Age3 monthsAssessed in years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026