Health Economy Register

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of CANKADO in Breast Cancer Patients in Germany

Conditions
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Breast Neoplasms

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |