- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07283120
The Impact of Breast Surgery on Patients' Quality of Life
December 2, 2025 updated by: University Hospital, Basel, Switzerland
The investigators aim to document the surgery-specific and overall Quality of life parameters of patients undergoing all types of breast surgery at the University Hospital of Basel
Study Overview
Status
Recruiting
Conditions
Detailed Description
The planned ten-year follow-up using Patient reported outcome measure will give us the unique opportunity to gain insight into patients' breast-related QoL (Quality of Life) long after surgery and detect systematic issues that may affect them beyond the scope of routine follow-up consultations.
Along with the detection of any occurring adverse events, the information gathered in the database will facilitate the search for risk factors involved in their development, ideally resulting in their rectification and thus contributing to patient well-being in the long term.
Study Type
Observational
Enrollment (Estimated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elisabeth Kappos, Prof.
- Phone Number: +4161 265 25 25
- Email: elisabeth.kappos@usb.ch
Study Locations
-
-
-
Basel, Switzerland, 4031
- Recruiting
- University Hospital Basel
-
Contact:
- Elisabeth Kappos, Prof.
- Phone Number: +41 61 265 25 25
- Email: elisabeth.kappos@usb.ch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
patients who underwent breast surgery at the University Hospital Basel from 2014 onwards
Description
Inclusion Criteria:
- adults who underwent any type of breast surgery at the University Hospital of Basel
Exclusion Criteria:
- Patients under the age of 18 years, without general consent or written informed consent, with insufficient language comprehension or other factors limiting their ability to co-operate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction
Time Frame: up to 10 years
|
five point likert-scale for satisfaction ( psychometric survey response scale ranging from "Strongly Disagree" to "Strongly Agree".
The format includes: 1. Strongly Disagree, 2. Disagree, 3. Neutral (or Neither Agree nor Disagree), 4. Agree, and 5. Strongly Agree Descriptive measures using patient-reported outcome measures (BREAST-Q, McGill short form, EQ-5D-5L)
|
up to 10 years
|
|
Patient reported quality of life
Time Frame: up to 10 years
|
Descriptive measures using patient-reported outcome measures (BREAST-Q, McGill short form, EQ-5D-5L)
|
up to 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Elisabeth Kappos, Prof., University Hospital, Basel, Switzerland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 16, 2025
Primary Completion (Estimated)
June 30, 2035
Study Completion (Estimated)
June 30, 2035
Study Registration Dates
First Submitted
December 2, 2025
First Submitted That Met QC Criteria
December 2, 2025
First Posted (Actual)
December 15, 2025
Study Record Updates
Last Update Posted (Actual)
December 15, 2025
Last Update Submitted That Met QC Criteria
December 2, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2025-00210; bb25kappos3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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