Satisfaction and QUality of Life After Breast REconstruction

NCT04329819 | Completed

• 1 other identifier: ICO-2019-16
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common cancer in women in France in term of repercussion, 58 698 people has been diagnosed in 2017. Breast cancer is often with good prognosis. The 5 years disease-free survival rate is 87%. Surgery has a major place in breast cancer treatment. Although the conservative surgery is preferred, it stays the indication of mastectomy for nearly 30% of cases. This radical surgery is often experienced by the patient as a mutilation with the impact that this entails from a psychological point of view but also on the quality of life. Breast reconstruction allows an improvement of quality of life with a better acceptance of the body scheme and the benefits in the psychological and sexual domains. The reconstruction is an integral part of the therapeutic care; however, it is not done systematically. Indeed, in France nearly 35% of patients benefit of breast reconstruction 5 years after the mastectomy. Nowadays, several surgical technics are available to do the reconstruction: autologous technics and the reconstruction with implants. It can be differed or immediate. The strategy of reconstruction is established in accordance with many parameters: the morphology of the breast and of the patient, the state of the thoracic wall and history of radiotherapy, comorbidities, contraindication and of course the wish of the patient. According to the used technics, the reconstruction can sometimes extend to several months, especially for the exclusive fat reshaping which needs a lot of surgery. The autologous technics seems to give a better satisfaction to the patients in an esthetical point of view but we do not have many data including the fat reshaping. Among the tests allowing the evaluation of quality of life of patients, the Breast-Q© is a self-questionnaire validated that is specific to the breast surgery and includes a module concerning the breast reconstruction. It allows evaluating the quality of life (physical, psychosocial and sexual well-being) and the satisfaction of patients (based on cosmetic results and the care). The reconstruction module includes 116 items in its post-surgery version and is adapted to different types of reconstruction. The objective of our project is to evaluate the quality of life and the satisfaction of patients having an immediate or differed breast reconstruction according to the technics used, with the help of the validated questionnaire Breast-Q© and the additional questionnaires.

Conditions

Mammaplasty; Breast Neoplasm Female

Outcome Measures

Primary Outcomes (1)

• Evaluate the quality of life and the satisfaction of patients who had a breast reconstruction immediate or differed according to the technics used

  The evaluation will be done through the BREAST-Q© questionnaire (module of reconstruction and post-surgery version) The quality of life is evaluated through 6 scales (psychological and sexual well-being and also physical well-being: breast, abdomen/trunk, shoulder/back). The satisfaction is evaluated with 9 scales (satisfaction of breast, nipples, abdomen, back and treatment: information received, surgeon, medical team and administrative staff). There is no global score for BREAST- Q©. Each scale is independent and converted from 0 to 100. A high score means a better satisfaction of quality of life.

  2 months

Secondary Outcomes (1)

• Describe the practices in term of breast reconstruction in the Institut de Cancerologie de l'Ouest-site Saint-Herblain.

  2 months

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 who had finished the breast reconstruction immediate or differed between 01/01/2015 and 31/12/16 whatever the technic used, following the mastectomy for breast cancer at the Institut de Cancerologie de l'Ouest, site Saint-Herblain

You may qualify if:

• Patients 18 years old or more
• History of mastectomy for breast cancer all types and TNM status
• Patients who beneficiated a breast reconstruction immediate or secondary finished between 01/01/2015 and 31/12/16 (not included nipples)
• Accept to answer to the questionnaire

You may not qualify if:

• Deceased patient
• Opposition of the patient to the data collection
• History of preventive mastectomy
• Patient who has local recurrence or metastatic cancer
• Patient under guardianship or protection of vulnerable adults

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancerologie de l'Ouest

Saint-Herblain, 44805, France

Location

Study Officials

• Victoire BRILLAUD-MEFLAH

  Institut de Cancerologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: September 3, 2019
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: April 1, 2020

Record last verified: 2020-03

Locations

FR (1)