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Completed

NCT Number: NCT04386629

Health Economy Register

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hämato-onkologischer Studienkreis am Klinikum Aschaffenburg, Aschaffenburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Occasion of consultation

    Time frame: 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.

  2. Frequency of consultation

    Time frame: 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.

  3. Duration of consultation

    Time frame: 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 outcomes

  1. Quality of life (QoL): Quality of Life Questionnaire (FACT-B)

    Time frame: 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

  2. Estimate usage satisfaction of healthcare professionals: minutes

    Time frame: 3 months

    The usage satisfaction of healthcare professionals was evaluated by assessing the impact on workload of CANKADO assessed in minutes.

  3. Age

    Time frame: 3 months

    Assessed in years

  4. Gender

    Time frame: 3 months

    Assessed as male/female

  5. Grade of education

    Time frame: 3 months

    Assessed as following options: secondary modern school, secondary school, abitur, university degree, promotion

  6. Number of inhabitants in hometown

    Time frame: 3 months

  7. German home state

    Time frame: 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

  8. Location of treatment

    Time frame: 3 months

    Assessed as: university hospital, hospital, haemato-oncologist, gynaecologic oncologist

  9. Year of primary brest cancer diagnosis

    Time frame: 3 months

  10. Radiotherapy treatment of patient

    Time frame: 3 months

    assessed as: yes/no

  11. Oral cancer treatment of patient

    Time frame: 3 months

    assessed as: yes/no

  12. Treatment of patient with osteopretectics

    Time frame: 3 months

    assessed as: yes/no

  13. Treatment of patient against high blood pressure

    Time frame: 3 months

    assessed as: yes/no

  14. Treatment of patient against diabetes

    Time frame: 3 months

    assessed as: yes/no

  15. Treatment of patient against asthma

    Time frame: 3 months

    assessed as: yes/no

  16. employment status of patient

    Time frame: 3 months

    assessed as : employed, not employed, retirement

Sponsors and collaborators

Lead sponsor

Cankado GmbH

Industry

Collaborators

  • Amgen

Registry information

Official study title

Evaluation of CANKADO in Breast Cancer Patients in Germany

Acronym: GeRA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 13, 2020
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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