Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02572-45 | Other Identifier | ID-RCB - ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | The quality of life measured with different scales (BREAST-Q, EORTC QLQ C30 and BR42) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality 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. | From enrollment to the end of 5 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Primary care clinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Massimo LODI, MD | Contact | 0033389124171 | massimo.lodi@ch-colmar.fr | |
| Magali EYRIEY | Contact | 0033389124810 | magali.eyriey@ch-colmar.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Civils de Colmar | Recruiting | Colmar | 68024 | France |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | At enrollment aund day 1 and 7 after surgery |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |