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Breast NeoplasmsGeRANCT04386629

Health Economy Register

An observational study of Breast Neoplasms, run by Cankado GmbH at 10 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasms
How many people
219 participants
Where
10 sitesGermany
Study dates
5 Jul 2019to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients under medical treatment for breast cancer with access to CANKADO will be included in the analysis. This study will take place in at least 10 German centers with CANKADO access / participation representatively distributed in Germany.

Who may be able to join

  • Men and women with breast cancer
  • Ongoing medical drug treatment
  • 18 years or older
  • CANKADO account

Who cannot join

  • Lack of consent to study participation or lack of patient's ability to stuconsent

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • Hämato-onkologischer Studienkreis am Klinikum Aschaffenburg

    Aschaffenburg, 63739

  • Kliniken der Stadt Köln - Krankenhaus Holweide, Brustzentrum

    Cologne, 51067

  • Kliniken Essen Mitte

    Essen, 45136

  • Onkology Bethanien Frankfurt

    Frankfurt, 60389

  • Mammazentrum Hamburg Am Krankenhaus Jerusalem

    Hamburg, 20357

  • University Hospital

    Mainz, 55131

  • University Hospital

    Mannheim, 68167

  • University Hospital

    München, 80377

  • Johanna Etienne Krankenhaus

    Neuss, 41462

  • Praxisnetzwerk Hämatologie/ intern. Onkologie

    Troisdorf, 53840

Other trials in Germany

About this study

Official title: Evaluation of CANKADO in Breast Cancer Patients in Germany

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.

Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

  3. 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.

    Measured: 3 months

Secondary outcomes (16)

  1. 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

    Measured: 3 months

  2. 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.

    Measured: 3 months

  3. Age

    Assessed in years

    Measured: 3 months

  4. Gender

    Assessed as male/female

    Measured: 3 months

  5. Grade of education

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

    Measured: 3 months

  6. Number of inhabitants in hometown

    Measured: 3 months

  7. 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

    Measured: 3 months

  8. Location of treatment

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

    Measured: 3 months

  9. Year of primary brest cancer diagnosis

    Measured: 3 months

  10. Radiotherapy treatment of patient

    assessed as: yes/no

    Measured: 3 months

  11. Oral cancer treatment of patient

    assessed as: yes/no

    Measured: 3 months

  12. Treatment of patient with osteopretectics

    assessed as: yes/no

    Measured: 3 months

  13. Treatment of patient against high blood pressure

    assessed as: yes/no

    Measured: 3 months

  14. Treatment of patient against diabetes

    assessed as: yes/no

    Measured: 3 months

  15. Treatment of patient against asthma

    assessed as: yes/no

    Measured: 3 months

  16. employment status of patient

    assessed as : employed, not employed, retirement

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2020
  2. Study start5 Jul 2019
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04386629
Sponsor's protocol ID
20180349
Acronym
GeRA
Status last verified
Feb 2021
First submitted
4 May 2020
Last updated
8 Feb 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms, run by Cankado GmbH at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occasion of consultation (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04386629.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.

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