NCT04386629

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

May 4, 2020

Last Update Submit

February 4, 2021

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (16)

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

    3 months

  • Estimate usage satisfaction of healthcare professionals: minutes

    3 months

  • Age

    3 months

  • Gender

    3 months

  • Grade of education

    3 months

  • +11 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hämato-onkologischer Studienkreis am Klinikum Aschaffenburg

Aschaffenburg, 63739, Germany

Location

Kliniken der Stadt Köln - Krankenhaus Holweide, Brustzentrum

Cologne, 51067, Germany

Location

Kliniken Essen Mitte

Essen, 45136, Germany

Location

Onkology Bethanien Frankfurt

Frankfurt, 60389, Germany

Location

Mammazentrum Hamburg Am Krankenhaus Jerusalem

Hamburg, 20357, Germany

Location

University Hospital

Mainz, 55131, Germany

Location

University Hospital

Mannheim, 68167, Germany

Location

University Hospital

München, 80377, Germany

Location

Johanna Etienne Krankenhaus

Neuss, 41462, Germany

Location

Praxisnetzwerk Hämatologie/ intern. Onkologie

Troisdorf, 53840, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Timo Schinköthe, PhD

    Cankado GmbH

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 13, 2020

Study Start

July 5, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations

DE(10)