Quality of Life of Patients Who Have Undergone Bilateral Mastectomy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Grenoble

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female sex

Age ≥ 18 years

Bilateral mastectomy

Breast reconstruction between January 1, 2015, and January 1, 2026

Disqualifiers

Individual under guardianship or curatorship, or deprived of liberty

Reconstruction not completed by January 1, 2026.

Trial 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).

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

115 Participants
are grouped into 3 trial groups
Group A: Bilateral prophylactic mastectomy
Group B: Bilateral therapeutic mastectomy
Group C: Therapeutic and prophylactic mastectomy

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months post operatively

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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