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.
Study Type
OBSERVATIONAL
Enrollment
1,500
The quality of life measured with different scales (BREAST-Q, EORTC QLQ C30 and BR42)
Hôpitaux Civils de Colmar
Colmar, France
RECRUITINGQuality of life measured with BREAST-Q
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.
Time frame: From enrollment to the end of 5 years follow-up
Quality of life measured with EORTC QLQ C30
The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time frame: From enrollment to the end of 5 years follow-up
Quality of life measured with EORTC QLQ-BR42
The Breast Cancer Module EORTC QLQ-BR42 is a 42-item instrument designed to measure quality of life in breast cancer patients. It is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. All of the scales and single item measures range in score from 0 to 100. A high score for the Body Image, Sexual Functioning and Breast Satisfaction scales and for the Future Perspective and Sexual Enjoyment single items represents a high level of functioning, whereas a high score for the Systemic ChemoTherapy Side Effects, Endocrine Symptoms, Arm Symptoms, Breast Symptoms, Hand/foot symptoms/neuropathy, Skeletal Scale and Vaginal Symptoms scales and for the Weight Gain single item represents a high level of symptomatology or problems.
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Time frame: From enrollment to the end of 5 years follow-up
Safety of postoperative period
Concerning safety, the endpoint is the duration of Hospital Free Survival (HFS) . HFS is defined as the time interval (in days) without any hospitalization from discharge until death.
Time frame: Form enrollment to the end of 5 years follow-up
Quality of postoperative period
Concerning the quality of the postoperative period, the enpoint is the quality of recovery assessed with the 15-item Quality of Recovery (QoR-15) scale. The QoR-15 scale is a validated multidimensional questionnaire that measures postoperative quality of recovery. The scale is ranges from 0 to 150. A higher QoR-15 score reflects higher recovery.
Time frame: At enrollment aund day 1 and 7 after surgery