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Study of the Quality of Life in Patients With Standard External Breast Prosthesis Compared to Patients With Custom-made Breast Prosthesis. (MEAVANTI)

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ClinicalTrials.gov Identifier: NCT03981263
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date June 13, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Change in quality of life : emotional functioning [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Change in quality of life : emotional functioning [ Time Frame: 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)
  • Change in quality of life : social functioning [ Time Frame: 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)
  • Change in quality of life : body image [ Time Frame: 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)
  • Change in quality of life : sexual functioning [ Time Frame: 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)
  • Change in quality of life : satisfaction breast cosmetic [ Time Frame: 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)
Change History Complete list of historical versions of study NCT03981263 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Visual satisfaction [ Time Frame: 6 months ]
    Evaluation of the visual satisfaction associated with wearing of the external prosthesis by the self and the hetero-evaluation (from photos taken of the patient (face, profiles, ¾ with and without the prosthesis): carried out by a scale of judgment (Likert type with 5 choices from 1 = very satisfied to 5 = very unsatisfied) at 6 months.
  • Evaluation of pain [ Time Frame: 3 months and 6 months ]
    Evaluation of pain by the analogical EVA scale 1 to 10, on the following 3 sites: back / shoulders / cervical at 3 monts and 6 months.
  • Comparative questionnaire [ Time Frame: 6 months ]
    Comparative questionnaire "adhoc" between the 2 prostheses will be performed at 6 months (that is to say at the end of the study) targeting specific issues to the wearing of prostheses (previously used by the HAS for the referencing of silicone prostheses). This questionnaire consists of 14 questions, type Likert 5 points.
  • Collection of adverse events [ Time Frame: 3 months and 6 months ]
    Adverse events will be recorded
  • Costs (consultations) [ Time Frame: 1 month, 3 Months, 4 months and 6 months ]
    Costs for consultations will be raised
  • Costs (paramedical procedures) [ Time Frame: 1 month, 3 Months, 4 months and 6 months ]
    Costs for paramedical procedures will be raised
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Visual satisfaction [ Time Frame: 6 months ]
    Evaluation of the visual satisfaction associated with wearing of the external prosthesis by the self and the hetero-evaluation (from photos taken of the patient (face, profiles, ¾ with and without the prosthesis): carried out by a scale of judgment (Likert type with 5 choices from 1 = very satisfied to 5 = very unsatisfied) at 6 months.
  • Evaluation of pain [ Time Frame: 3 months and 6 months ]
    Evaluation of pain by the analogical EVA scale 1 to 10, on the following 3 sites: back / shoulders / cervical at 3 monts and 6 months.
  • Comparative questionnaire [ Time Frame: 6 months ]
    Comparative questionnaire "adhoc" between the 2 prostheses will be performed at 6 months (that is to say at the end of the study) targeting specific issues to the wearing of prostheses (previously used by the HAS for the referencing of silicone prostheses). This questionnaire consists of 14 questions, type Likert 5 points).
  • Adverse events [ Time Frame: 3 months and 6 months ]
    Adverse events will be recorded
  • Costs (consultations) [ Time Frame: 1 month, 3 Months, 4 months and 6 months ]
    Costs for consultations will be raised
  • Costs (paramedical procedures) [ Time Frame: 1 month, 3 Months, 4 months and 6 months ]
    Costs for paramedical procedures will be raised
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Quality of Life in Patients With Standard External Breast Prosthesis Compared to Patients With Custom-made Breast Prosthesis.
Official Title  ICMJE Study of the Quality of Life in Patients With Standard External Breast Prosthesis Compared to Patients With Custom-made Breast Prosthesis. MEAVANTI Project.
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.
Detailed Description

In France, breast cancer is a public health issue with around 59,000 new cases per year. Despite improved surgical techniques, there is still around 30% mastectomy performed every year. Definitively or temporarily, one of the alternatives to restore a volume in the bra is the use of external breast prosthesis. Currently, there are 3 silicone brands that are marketed and refunded. These standard prostheses take into account only the curve of the patients and not the weight of the remaining breast making adaptation difficult to all body types. The difference in breast weights can cause several disorders: postural, pain, discomfort, psychological impact on quality of life as well as medico-economic impact. MEAVANTI is an external breast prosthesis for custom calibration and personalization, which can prevent postural compensation and provide greater comfort.

The main objective of this study is therefore to evaluate whether the MEAVANTI prosthesis improves the quality of life of patients who have undergone a mastectomy compared to the standard prosthesis (through the EORTC questionnaires - European Organization for Research and Treatment of Cancer). This study will be monocentric, cross-over (2 periods), prospective, open with a wash-out period of 15 days. The period of the study will be conducted over 13 months.

The expected benefits can be major. The main benefit expected is the improvement of quality of life of the patients carrying the MEAVANTI breast prosthesis compared to those carrying the so-called standard prosthesis. A reduction in back and neck pain could also reduce the costs of patient management. In addition, this will demand referencing by the HAS of the custom-made prosthesis so that it is reimbursed in the same way as existing ones.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Cross-over (2 periods), prospective, open and monocentric study. The wash-out period will be 15 days
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Device: MEAVANTI prothesis

    The experimental prosthesis is the MEAVANTI prosthesis ("custom-made" non-adherent prosthesis in silicone) which can be calibrated to 5 grams near the breast that remains after a mastectomy to create a visual symmetry but also a weight symmetry.

    This prosthesis takes into account the curve of the breasts and the morphological details such as: skin color of the patients, size of the nipples, height of the nipples, shape of the breast.

    The measurements of the patients will be taken using a 3D scanner (i.e. a scanner that corresponds to a 3d scanning and acquiring device (images), not irradiating), a scale and a colour chart.

  • Device: Standard prothesis
    This prosthesis will be compared with a standard non-adherent prosthesis (class I, silicone and polyurethane film), among the models available in the three ranges of standard prostheses (Amoena, Anita and Thuasne). The brand and model will be left to the patient's choice.
Study Arms  ICMJE
  • MEAVANTI + Standard protheses
    The patients will benefit from the experimental prothesis (MEAVANTI), after a wash-out period of 15 days, they will benefit from the standard non-adherent prothesis.
    Interventions:
    • Device: MEAVANTI prothesis
    • Device: Standard prothesis
  • Standard + MEAVANTI protheses
    The patients will benefit from the standard non-adherent prothesis, after a wash-out period of 15 days, they will benefit from the experimental prothesis (MEAVANTI).
    Interventions:
    • Device: MEAVANTI prothesis
    • Device: Standard prothesis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2019)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Unilateral mastectomy performed.
  • Satisfactory healing
  • Informed consent form signed.
  • Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

  • Elastomer type plastics or silicone allergy
  • Contraindication to the use of the MEAVANTI or Standard external prosthesis: damaged or irritated skin in the area of application of the prosthesis
  • Patient under the age of 18 years
  • History of back problems (scoliosis)
  • History of spine surgery
  • Other cancer being treated,
  • Dorsal hyperalgia
  • Acute infectious episode (cellulitis, erysipelas, lymphangitis)
  • Presence of subcutaneous osteosynthesis material with an external part at the level of the upper limb to be treated,
  • Impossibility to comply with the constraints of the protocol,
  • Pregnancy,
  • Breast feeding
  • Adult protected by law (tutelage, curators and safeguard of justice).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female with a breast cancer
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Charlotte VAYSSE, MCU-PH 5 31 15 53 84 ext 33 vaysse.c@chu-toulouse.fr
Contact: Eva JOUVE, PH 5 31 15 60 24 ext 33 jouve.eva@iuct-oncopole.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03981263
Other Study ID Numbers  ICMJE RC31/17/0335
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Charlotte VAYSSE, MCU-PH University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP