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NCT Number: NCT07699913

Quality of Life of Patients Who Have Undergone Bilateral Mastectomy

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.

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Key information

Conditions

Surgery Date Age BMI BRCA Mutation Body Weight Chemotherapy Height Hormone Therapy Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Radiotherapy Signs and Symptoms Smoking Status Timing of Reconstruction Type of Mastectomy (Prophylactic or Therapeutic) Type of Reconstruction (Flap or Implant) Weight

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Psychological Experience, Quality of Life, and Patient Satisfaction Following Bilateral Breast Reconstruction After Prophylactic or Therapeutic Mastectomy, Using the BREAST-Q Questionnaire.

Acronym: RM BREAST Q

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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