Assessing Quality of Life After Breast Cancer Surgery: a Prospective Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer Surgery
- Sponsor
- Centre Hospitalier de Colmar
- Enrollment
- 1500
- Locations
- 1
- Primary Endpoint
- Quality of life measured with BREAST-Q
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
The goal of this observational study is to prospectively collect data on quality of life after oncoplastic breast surgery.
Participants will be followed-up and answer quality of life questionnaire for a duration of 5 years after surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient aged 18 or over
- •Patient with breast cancer of any stage (including in situ) or healthy individual at high personal risk.
- •Patient requiring breast surgery under general anesthesia, whether for therapeutic or prophylactic purposes.
- •Patient capable, in the opinion of the investigator, of complying with the requirements and restrictions of the study.
- •Patient with a computer, tablet or smartphone connected to the Internet.
- •Patient followed in the center on a regular basis according to standard recommendations.
Exclusion Criteria
- •Patient requiring surgical intervention under local anesthesia only.
- •Patient requiring surgery for the installation or removal of an chemotherapy implantable port only.
- •Patients with a history of cancer other than breast cancer. Patients with a history of cancer more than three years old are eligible if they are treated and considered cured. Patients with a history of cervical carcinoma in situ or non-melanoma skin carcinoma are eligible.
- •Impossibility of being subject to regular monitoring for geographical, social or psychological reasons.
- •Patient under protective measure
Outcomes
Primary Outcomes
Quality of life measured with BREAST-Q
Time Frame: From enrollment to the end of 5 years follow-up
The BREAST-Q is a rigorously developed patient-reported outcome measure for use in cosmetic and reconstructive breast surgery and clinical practice. The BREAST-Q conceptual framework covers 2 domains: quality of life, and patient satisfaction. There is three independent modules developped for breast cancer (mastectomy, breast-conserving therapy, reconstruction). A conversion table is used to convert the raw scale summed score into a score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Secondary Outcomes
- Quality of life measured with EORTC QLQ C30(From enrollment to the end of 5 years follow-up)
- Quality of life measured with EORTC QLQ-BR42(From enrollment to the end of 5 years follow-up)
- Safety of postoperative period(Form enrollment to the end of 5 years follow-up)
- Quality of postoperative period(At enrollment aund day 1 and 7 after surgery)