Widening Aims and Giving Patients a Voice for Expanded Structures in Breast Cancer Care Jointly Developed by Patients and Physicians

NCT06416293 | Recruiting

• 1 other identifier: 2.0
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Communication; patient-physician-relationship; questionnaire

Outcome Measures

Primary Outcomes (1)

• Current state of care - patient view

  The primary aim of the questionnaire is to record the current reality of care for breast cancer patients with a focus on communication.

  through study completion, an average of 3 years

Secondary Outcomes (1)

• Current state of care - physician view

  through study completion, an average of 3 years

Study Arms (2)

BC Patients

Patients with diagnosis of breast cancer or DCIS

Other: Questionnaire patients

Physicians

Physicians treating patients with breast cancer

Other: Questionnaire physicians

Interventions

Questionnaire patients OTHER

Completion of a two-part questionnaire with a special focus on communication around the breast cancer diagnosis. Tumor stage and therapies received are also surveyed. The questionnaire can be answered online via a secure tool (REDCap) or in paper form.

BC Patients

Questionnaire physicians OTHER

Completion of a questionnaire with a special focus on communication around the breast cancer diagnosis

Physicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women and men aged 18 years and older with breast cancer. Physicians treating breast cancer patients.

You may qualify if:

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

You may not qualify if:

• women and men \< 18 years
• no histologically confirmed breast cancer or DCIS diagnosis
• \- Treatment of breast cancer patients

Sponsors & Collaborators

• University Hospital Augsburg: lead
• Wuerzburg University Hospital: collaborator
• Technical University of Munich: collaborator
• LMU Klinikum: collaborator
• University Hospital Regensburg: collaborator
• University Hospital Erlangen: collaborator
• Bavarian Cancer Research Center (BZKF): collaborator

Study Sites (1)

University Hospital Augsburg, Department of Gynecology and Obstetrics

Augsburg, Bavaria, 86156, Germany

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Communication

Condition Hierarchy (Ancestors)

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

Study Officials

• Nina Ditsch, Prof.

  University Hospital Augsburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Ditsch, Prof.

CONTACT

+49 821 400 15809; nina.ditsch@uk-augsburg.de

Melitta Köpke, Dr.

CONTACT

+49 821 400 165862; melitta.koepke@uk-augsburg.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Breast Centre University Hospital Augsburg, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: May 16, 2024
• Study Start: April 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

DE (1)