Clinical trial NCT06416293: Widening Aims and Giving Patients a Voice for Expanded Structures in Breast Cancer Care Jointly Developed by Patients and Physicians
Official title: Widening Aims and Giving Patients a Voice for Expanded Structures in Breast Cancer Care Jointly Developed by Patients and Physicians (Wechselseitiger Patienten-Arzt-Austausch in Der Versorgung Bei Brustkrebs Mit Dem Ziel Der Gemeinsamen Erarbeitung Neuer Patienten-orientierter Strukturen)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Communication
patient-physician-relationship
questionnaire
Lead sponsor: University Hospital Augsburg
Sponsor class: OTHER
Collaborators: name: Wuerzburg University Hospital
name: Technical University of Munich
name: LMU Klinikum
name: University Hospital Regensburg
name: University Hospital Erlangen
name: Bavarian Cancer Research Center (BZKF)
First posted: 2024-05-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women and men aged 18 years and older with breast cancer. Physicians treating breast cancer patients.

Brief summary: The aim of this BZKF project is to record the current care structure for breast cancer patients in order to use this as a basis for developing possible future models for improvement. The active involvement of representatives of regional and national patient organizations in the creation of a patient-based and patient-oriented survey ensures that the needs of patients are the focus. In addition to and in contrast to other projects, relevant questions are explicitly addressed not only to patients but also to physicians in order to identify and specify the interfaces between patient wishes/suggestions and to develop clinical consequences for care.

The first objective is to survey the "current situation" by recording the current care structure for breast cancer. The focus is on the survey of both groups on patient-physician communication, time management and coping strategies.

By planning the future harmonization of national data structures, the basis is created for the long-term goal of an improved "target", a concept developed jointly by physicians and patients for an improved communication and care structure that focuses on the patient.


Eligibility criteria: Inclusion Criteria (patients):

* Breast cancer or DCIS
* women and men aged 18 years and older

Exclusion Criteria (patients):

* women and men \< 18 years
* no histologically confirmed breast cancer or DCIS diagnosis

Inclusion Criteria (physicians):

- Treatment of breast cancer patients

Primary outcomes:
measure: Current state of care - patient view
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: Current state of care - physician view
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: University Hospital Augsburg, Department of Gynecology and Obstetrics
state: Bayern
Study officials:
affiliation: University Hospital Augsburg
name: Nina Ditsch, Prof.
role: PRINCIPAL_INVESTIGATOR
References: