## Protocol Section
### Identification Module
**NCT ID:** NCT06416293

**Acronym:** WAVES

**Brief Title:** 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)

#### Organization Study ID Info
**ID:** 2.0
#### Organization
**Class:** OTHER
**Full Name:** University Hospital Augsburg
### Status Module
#### Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-08
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Wuerzburg University Hospital

**Class:** OTHER

**Name:** Technical University of Munich

**Class:** OTHER

**Name:** LMU Klinikum

**Class:** OTHER

**Name:** University Hospital Regensburg

**Class:** OTHER

**Name:** University Hospital Erlangen

**Class:** UNKNOWN

**Name:** Bavarian Cancer Research Center (BZKF)

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital Augsburg

#### Responsible Party

**Investigator Affiliation:** University Hospital Augsburg

**Investigator Full Name:** Nina Ditsch

**Investigator Title:** Head of Breast Centre University Hospital Augsburg, Principal Investigator, Clinical Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Breast Cancer

**Keywords:**

- Communication

- patient-physician-relationship

- questionnaire

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 2000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with diagnosis of breast cancer or DCIS

**Intervention Names:**

- Other: Questionnaire patients

**Label:** BC Patients

#### Arm Group 2

**Description:** Physicians treating patients with breast cancer

**Intervention Names:**

- Other: Questionnaire physicians

**Label:** Physicians

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BC Patients

**Description:** 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.

**Name:** Questionnaire patients

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Physicians

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

**Name:** Questionnaire physicians

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Current state of care - patient view

**Time Frame:** through study completion, an average of 3 years

#### Secondary Outcomes

**Description:** Secondarily, a comparison will be made with the physicians assessment of the same topics

**Measure:** Current state of care - physician view

**Time Frame:** through study completion, an average of 3 years

### Eligibility Module

**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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Women and men aged 18 years and older with breast cancer. Physicians treating breast cancer patients.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nina.ditsch@uk-augsburg.de

**Name:** Nina Ditsch, Prof.

**Phone:** +49 821 400 15809

**Role:** CONTACT

**Contact 2:**

**Email:** melitta.koepke@uk-augsburg.de

**Name:** Melitta Köpke, Dr.

**Phone:** +49 821 400 165862

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Augsburg

**Contacts:**

***Contact 1:***

- **Email:** nina.ditsch@uk-agsburg.de

- **Name:** Nina Ditsch, Prof.

- **Phone:** +49 821 400 165809

- **Role:** CONTACT

***Contact 2:***

- **Email:** melitta.koepke@uk-augsburg.de

- **Name:** Melitta Köpke, Dr.

- **Phone:** +49 821 400 165862

- **Role:** CONTACT

**Country:** Germany

**Facility:** University Hospital Augsburg, Department of Gynecology and Obstetrics

**State:** Bayern

**Status:** RECRUITING

**Zip:** 86156

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital Augsburg

**Name:** Nina Ditsch, Prof.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
