Assessment of Health Related Quality of Life in Women Who Underwent Breast Reconstruction After Radical Surgery

NCT04938505 | Unknown

• 1 other identifier: 2018-A011828-47
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Nowadays, breast reconstruction is an integral care after mastectomy in breast cancer patient. With the personalized care, choice a breast reconstructive is an important step involving decisions and mutual accord between patients and their physicians in order to anticipate clinical and psychosocial results. Two main families of breast reconstruction techniques are often performed including advantages and complications impacting health related quality of life. Routine assessment of health related quality of life in patients underwent breast reconstruction could allow to identify factors of satisfaction o be taken into account in the choice of breast reconstruction technique in order to improve practices and quality of life of patients

Conditions

Breast Cancer

Keywords

Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• Health related quality of life scores assessed by Breast Q questionnaire

  12 months after breast reconstruction

Secondary Outcomes (7)

• Number of anxious and depress participants as assessed by Hospital Anxiety and Depression Scale (HADS)

  12 months after breast reconstruction

• social support as assessed by Sarason's Social Support Questionnaire 6-item (SSQ6)

  12 months after breast reconstruction

• level of the precariousness and the disparities of health at breast reconstruction patient by the questionnaire Evaluation of the Precariousness and the Disparities of Health for the Centers of Examination of Health (EPICES)

  12 months after breast reconstruction

• Health related quality of life scores assessed by Breast Q questionnaire

  24 months after breast reconstruction

• Health related quality of life scores assessed by Breast Q questionnaire

  36 months after breast reconstruction

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

Patient undergoing breast reconstruction after mastectomy for breast cancer

You may qualify if:

• Normal Breast Checkup ( Mammography, echography and breast magnetic resonance imaging)in the previous 6 months
• French speaking and writing fluency
• Agree to participate after receive all information

You may not qualify if:

• Patients with an inability to complete HRQOL questionnaires (cognitive disorders, language barrier)
• Patient with a failed first breast reconstruction

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges Francois Leclerc

Dijon, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clementine JANKOWSKI, MD

  Centre Georges François Leclerc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandrine DABAKUYO, PHD

CONTACT

0345348067; sdabakuyo@cgfl.fr

Study Design

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

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 24, 2021
• Study Start: May 4, 2019
• Primary Completion: May 4, 2024
• Study Completion: May 4, 2025
• Last Updated: June 24, 2021

Record last verified: 2021-06

Locations

FR (1)