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Studies

Interventional Recruiting

NCT03981263 on ClinicalTrials.gov

Quality of Life in Patients With Standard External Compared to Custom-made Breast Prosthesis.

Official title: Study of the Quality of Life in Patients With Standard External Breast Prosthesis Compared to Patients With Custom-made Breast Prosthesis. MEAVANTI Project.

  • Sponsor: Hôpital Rangueil
  • Enrollment: 64 (Estimated)
  • Study start: 2021-01-28 (Actual)
  • Primary completion: 2024-05-01 (Estimated)
  • Study completion: 2024-05-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Crossover
  • InterventionModelDescription: Cross-over (2 periods), prospective, open and monocentric study. The wash-out period will be 15 days
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

Despite improvements in surgical techniques, approximately 30% of mastectomies are still performed. Definitively or temporarily, one of the alternatives to restore a volume in the bra is the external breast prosthesis. The main objective is to evaluate whether the "custom-made" MEAVANTI prosthesis improves the quality of life of patients who have had a mastectomy compared to the external standard prosthesis.

Conditions

  • Breast Cancer

Intervention / Treatment

  • Device: MEAVANTI prothesis
  • Device: Standard prothesis

Primary Outcome Measures

  • Change in quality of life : emotional functioning (Change from baseline to 3 months)
    Emotional dimension will be studied with items from 21 to 24 of EORTC Quality of Life Questionnaire QLQ-C30 (Generic Questionnaire) (Likert type with 4 choices from 1 = not at all to 4 = a lot)
  • Change in quality of life : social functioning (Change from baseline to 3 months)
    Social dimension will be studied with items from 26 and 27 of EORTC Quality of Life Questionnaire QLQ-C30 (Generic Questionnaire) (Likert type with 4 choices from 1 = not at all to 4 = a lot)
  • Change in quality of life : body image (Change from baseline to 3 months)
    Body image will be studied with items from 39 to 42 of EORTC Quality of Life Questionnaire BR23 Module (Breast Cancer Module) (Likert type with 4 choices from 1 = not at all to 4 = a lot)
  • Change in quality of life : sexual functioning (Change from baseline to 3 months)
    Sexual functioning will be studied with items from 56 to 59 of EORTC Quality of Life Questionnaire BRECON 14 (Reconstruction module) (Likert type with 4 choices from 1 = not at all to 4 = a lot)
  • Change in quality of life : satisfaction breast cosmetic (Change from baseline to 3 months)
    Satisfaction breast cosmetic will be studied with items from 60 to 65 of EORTC Quality of Life Questionnaire BRECON 14 (Reconstruction module) (Likert type with 4 choices from 1 = not at all to 4 = a lot)

Countries

France

Locations and Investigators

Study Officials