Quality of Life of Patients Who Have Undergone Bilateral Mastectomy

NCT07699913 | Not Yet Recruiting

• 1 other identifier: 2026-A00794-47
• Study Type: observational
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief 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 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; Hormone Therapy; Chemotherapy; Radiotherapy; Postoperative Complications; Type of Reconstruction (Flap or Implant); Timing of Reconstruction; Type of Mastectomy (Prophylactic or Therapeutic); BRCA Mutation

Keywords

Comparative; observational; retrospective

Outcome Measures

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.

  3 months post operatively

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• Female sex
• Age ≥ 18 years
• Bilateral mastectomy
• Breast reconstruction between January 1, 2015, and January 1, 2026
• No objection to the study

You may not qualify if:

• Individual under guardianship or curatorship, or deprived of liberty
• Reconstruction not completed by January 1, 2026.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

MeSH Terms

Conditions

Body Weight; Postoperative Complications

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: July 10, 2026
• Primary Completion: July 30, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07