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Recruiting NCT06416293

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

Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire patients, Questionnaire physicians.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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)

Overview

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.

Interventions

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

Primary outcome measures

  • Current state of care - patient view [Time frame: through study completion, an average of 3 years]
Secondary outcome measures (1)
  • Current state of care - physician view [Time frame: through study completion, an average of 3 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Germany · 1 center
  • University Hospital Augsburg, Department of Gynecology and Obstetrics — Augsburg

Identifiers

NCT: NCT06416293 · 2.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗