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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Questionnaire patients; Other: Questionnaire physicians

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Nina Ditsch, Prof.; Phone Number: +49 821 400 15809; Email: nina.ditsch@uk-augsburg.de
• Study Contact Backup: Name: Melitta Köpke, Dr.; Phone Number: +49 821 400 165862; Email: melitta.koepke@uk-augsburg.de

Study Locations

• Germany
  • Bayern
    • Augsburg, Bayern, Germany, 86156
      • Recruiting
      • University Hospital Augsburg, Department of Gynecology and Obstetrics
      • Contact: Melitta Köpke, Dr.; Phone Number: +49 821 400 165862; Email: melitta.koepke@uk-augsburg.de
      • Contact: Nina Ditsch, Prof.; Phone Number: +49 821 400 165809; Email: nina.ditsch@uk-agsburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BC Patients; Patients with diagnosis of breast cancer or DCIS	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.
Physicians; Physicians treating patients with breast cancer	Other: Questionnaire physicians; Completion of a questionnaire with a special focus on communication around the breast cancer diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital Augsburg
• Collaborators: Technical University of Munich; LMU Klinikum; Wuerzburg University Hospital; University Hospital Erlangen; University Hospital Regensburg; Bavarian Cancer Research Center (BZKF)
• Investigators: Principal Investigator: Nina Ditsch, Prof., University Hospital Augsburg

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: questionnaire; Communication; patient-physician-relationship
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No