Breast CancerWAVESNCT06416293
Widening Aims and Giving Patients a Voice for Expanded Structures in Breast Cancer Care Jointly Developed by Patients and Physicians
An observational study of Breast Cancer, run by University Hospital Augsburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Questionnaire patients and Questionnaire physicians
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women and men aged 18 years and older with breast cancer. Physicians treating breast cancer patients.
Who may be able to join
- Breast cancer or DCIS
- women and men aged 18 years and older
- Treatment of breast cancer patients
Who cannot join
- women and men < 18 years
- no histologically confirmed breast cancer or DCIS diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Augsburg, Department of Gynecology and Obstetrics
Augsburg, Bavaria, 86156
Nina Ditsch, Prof., +49 821 400 165809, nina.ditsch@uk-agsburg.de
Melitta Köpke, Dr., +49 821 400 165862, melitta.koepke@uk-augsburg.de
About this study
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)
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
- Being tested
- Questionnaire patients, Questionnaire physicians
- Keywords
- Communication, patient-physician-relationship, questionnaire
- Medical subject headings
- Breast Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire patientsOther
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 physiciansOther
Completion of a questionnaire with a special focus on communication around the breast cancer diagnosis
| Study group | Role | What they receive |
|---|---|---|
| BC Patients | Patients with diagnosis of breast cancer or DCIS Receives: Other: Questionnaire patients | |
| Physicians | Physicians treating patients with breast cancer Receives: Other: Questionnaire physicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 3 years
Secondary outcomes (1)
Current state of care - physician view
Secondarily, a comparison will be made with the physicians assessment of the same topics
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Collaborators
- Wuerzburg University Hospital, Technical University of Munich, LMU Klinikum, University Hospital Regensburg, University Hospital Erlangen, Bavarian Cancer Research Center (BZKF)
- Responsible party
- Principal investigator, Nina Ditsch, University Hospital Augsburg
- Investigators
- Nina Ditsch, Prof., Principal investigator, University Hospital Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416293
- Sponsor's protocol ID
- 2.0
- Acronym
- WAVES
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06416293
- Acronym / sponsor ID
- WAVES / 2.0
- Conditions
- Breast Cancer
- Keywords
- Communication, patient-physician-relationship, questionnaire
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Collaborators
- Wuerzburg University Hospital, Technical University of Munich, LMU Klinikum, University Hospital Regensburg, University Hospital Erlangen, Bavarian Cancer Research Center (BZKF)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BC Patients | – | Other: Questionnaire patientsPatients with diagnosis of breast cancer or DCIS |
| Physicians | – | Other: Questionnaire physiciansPhysicians treating patients with breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women and men aged 18 years and older with breast cancer. Physicians treating breast cancer patients.
Key inclusion criteria (3 listed)
- Breast cancer or DCIS
- women and men aged 18 years and older
- Treatment of breast cancer patients
Key exclusion criteria (2 listed)
- women and men < 18 years
- no histologically confirmed breast cancer or DCIS diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire patientsCompletion 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. | Other | BC Patients |
| Questionnaire physiciansCompletion of a questionnaire with a special focus on communication around the breast cancer diagnosis | Other | Physicians |
Primary outcome
Current state of care - patient view
Time frame: through study completion, an average of 3 years
The primary aim of the questionnaire is to record the current reality of care for breast cancer patients with a focus on communication.
1 secondary outcome
Current state of care - physician view
Time frame: through study completion, an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nina Ditsch, Prof. principal investigator
University Hospital Augsburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University Hospital Augsburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina Ditsch, Prof. (+49 821 400 15809, nina.ditsch@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Current state of care - patient view (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.