Surgery DateRM BREAST QNCT07699913
Quality of Life of Patients Who Have Undergone Bilateral Mastectomy
An observational study of Surgery Date and Age, run by University Hospital, Grenoble.
Trial summary
The investigators therefore aim to determine whether the type of mastectomy (preventive in a high-risk patient or therapeutic in a patient with a history of cancer), as well as the timing (immediate or delayed) and type of breast reconstruction, influence the quality of life and satisfaction of patients who have… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgery Date, Age, BMI
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2026to 20 Aug 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at CHU Grenoble Alpes for bilateral breast reconstruction between January 1, 2015, and January 1, 2026, in the plastic surgery and gynecology departments (departments performing breast reconstruction procedures).
Who may be able to join
- Female sex
- Age ≥ 18 years
- Bilateral mastectomy
- Breast reconstruction between January 1, 2015, and January 1, 2026
- No objection to the study
Who cannot join
- Individual under guardianship or curatorship, or deprived of liberty
- Reconstruction not completed by January 1, 2026.
About this study
Official title: Psychological Experience, Quality of Life, and Patient Satisfaction Following Bilateral Breast Reconstruction After Prophylactic or Therapeutic Mastectomy, Using the BREAST-Q Questionnaire.
The investigators therefore aim to determine whether the type of mastectomy (preventive in a high-risk patient or therapeutic in a patient with a history of cancer), as well as the timing (immediate or delayed) and type of breast reconstruction, influence the quality of life and satisfaction of patients who have undergone bilateral mastectomy. The goal of this observational study is thus to measure and compare the quality of life of patients who have undergone bilateral mastectomy using the BREAST-Q questionnaire.
- Conditions
- Surgery Date, Age, BMI, Height, Weight, Smoking Status
- Keywords
- Comparative, observational, retrospective
- Medical subject headings
- Body Weight, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral prophylactic mastectomy | The investigators will compare patients who underwent prophylactic bilateral mastectomy, prophylactic therapeutic and prophylactic and therapeutic mastectomy | |
| Bilateral therapeutic mastectomy | The investigators will compare patients who underwent prophylactic bilateral mastectomy, prophylactic therapeutic and prophylactic and therapeutic mastectomy | |
| Therapeutic and prophylactic mastectomy | The investigators will compare patients who underwent prophylactic bilateral mastectomy, prophylactic therapeutic and prophylactic and therapeutic mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the BREAST Q Questionnaire
Composite score on the standardized BREAST-Q questionnaire for the following domains: psychosocial well-being, sexual well-being, physical well-being, and breast satisfaction, starting at 3 months postoperatively.
A conversion table allows for conversion of the raw scale summed score into a score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Measured: 3 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery DateStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Retrospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699913
- Sponsor's protocol ID
- 2026-A00794-47
- Acronym
- RM BREAST Q
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 15 Jul 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Experience, Quality of Life, and Patient Satisfaction Following Bilateral Breast Reconstruction After Prophylactic or Therapeutic Mastectomy, Using the BREAST-Q Questionnaire.
- ClinicalTrials.gov ID
- NCT07699913
- Acronym / sponsor ID
- RM BREAST Q / 2026-A00794-47
- Conditions
- Surgery Date, Age, BMI, Height, Weight, Smoking Status
- Keywords
- Comparative, observational, retrospective
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 13 Jul 2026 (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 therefore aim to determine whether the type of mastectomy (preventive in a high-risk patient or therapeutic in a patient with a history of cancer), as well as the timing (immediate or delayed) and type of breast reconstruction, influence the quality of life and satisfaction of patients who have undergone bilateral mastectomy. The goal of this observational study is thus to measure and compare the quality of life of patients who have undergone bilateral mastectomy using the BREAST-Q questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilateral prophylactic mastectomy | – | –The investigators will compare patients who underwent prophylactic bilateral mastectomy, prophylactic therapeutic and prophylactic and therapeutic mastectomy |
| Bilateral therapeutic mastectomy | – | –The investigators will compare patients who underwent prophylactic bilateral mastectomy, prophylactic therapeutic and prophylactic and therapeutic mastectomy |
| Therapeutic and prophylactic mastectomy | – | –The investigators will compare patients who underwent prophylactic bilateral mastectomy, prophylactic therapeutic and prophylactic and therapeutic mastectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at CHU Grenoble Alpes for bilateral breast reconstruction between January 1, 2015, and January 1, 2026, in the plastic surgery and gynecology departments (departments performing breast reconstruction procedures).
Key inclusion criteria (5 listed)
- Female sex
- Age ≥ 18 years
- Bilateral mastectomy
- Breast reconstruction between January 1, 2015, and January 1, 2026
- No objection to the study
Key exclusion criteria (2 listed)
- Individual under guardianship or curatorship, or deprived of liberty
- Reconstruction not completed by January 1, 2026.
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
Measure of the BREAST Q Questionnaire
Time frame: 3 months post operatively
Composite score on the standardized BREAST-Q questionnaire for the following domains: psychosocial well-being, sexual well-being, physical well-being, and breast satisfaction, starting at 3 months postoperatively. A conversion table allows for conversion of the raw scale summed score into a score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
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 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery Date and Age, run by University Hospital, Grenoble.
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 5 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: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the BREAST Q Questionnaire (time frame: 3 months post operatively). 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 Jul 2026.