Breast SurgeryNCT07283120
The Impact of Breast Surgery on Patients' Quality of Life
An observational study of Breast Surgery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Surgery
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 May 2025to 30 Jun 2035
- How long will I take part?
- 10 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent breast surgery at the University Hospital Basel from 2014 onwards
Who may be able to join
- adults who underwent any type of breast surgery at the University Hospital of Basel
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Elisabeth Kappos, Prof., +41 61 265 25 25, elisabeth.kappos@usb.ch
About this study
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
Read the 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.
- Conditions
- Breast Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
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)
Measured: up to 10 years
Patient reported quality of life
Descriptive measures using patient-reported outcome measures (BREAST-Q, McGill short form, EQ-5D-5L)
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start16 May 2025
- Primary completion30 Jun 2035 (estimated)
- Study completion30 Jun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kappos, Prof., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283120
- Sponsor's protocol ID
- 2025-00210; bb25kappos3
- Other IDs
- 2025
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- 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 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Breast Surgery on Patients' Quality of Life
- ClinicalTrials.gov ID
- NCT07283120
- Acronym / sponsor ID
- 2025-00210; bb25kappos3
- Conditions
- Breast Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- 30 Jun 2035 (estimated)
- Study completion
- 30 Jun 2035 (estimated)
- First posted
- 15 Dec 2025 (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 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
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent breast surgery at the University Hospital Basel from 2014 onwards
Key inclusion criteria (1 listed)
- adults who underwent any type of breast surgery at the University Hospital of Basel
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
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 15 Dec 2025.
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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.
Elisabeth Kappos, Prof. principal investigator
University Hospital, Basel, Switzerland
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 Surgery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 1 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 15 Dec 2025. 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 Switzerland. 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 Elisabeth Kappos, Prof. (+4161 265 25 25, elisabeth.kappos@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: up to 10 years). The study lists 2 primary outcomes in all. 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 15 Dec 2025.