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

Breast Cancer Clinical Trial

— WAVES  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06416293
• Other study ID #: 2.0
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: University Hospital Augsburg
• Contact: Nina Ditsch, Prof.
• Phone: +49 821 400 15809
• Email: nina.ditsch[@]uk-augsburg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Questionnaire patients
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.
• Questionnaire physicians
Completion of a questionnaire with a special focus on communication around the breast cancer diagnosis

Locations

Country	Name	City	State
Germany	University Hospital Augsburg, Department of Gynecology and Obstetrics	Augsburg	Bayern

Sponsors (7)

Lead Sponsor	Collaborator
University Hospital Augsburg	Bavarian Cancer Research Center (BZKF), LMU Klinikum, Technical University of Munich, University Hospital Erlangen, University Hospital Regensburg, Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Current state of care - physician view	Secondarily, a comparison will be made with the physicians assessment of the same topics	through study completion, an average of 3 years