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This project is a follow-on study of the BEAUTIFY-2 study (NCT04957186). The "BEAUTIFY" (BrEast cAncer qUaliTy of lIfe aFter surgerY) program was built by a committee of experts on the basis of reflections carried out within 2 focus groups. An application was developed to track patient reported outcome measures.
The study investigators now wish to evaluate the feasibility and impact on pain and quality of life of the "BEAUTIFY" care pathway on a larger cohort. The study hypothesis is that multidisciplinary care organization will improve the management and the quality of life post-breast cancer surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BEAUTIFY application | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEAUTIFY application | Device | Interview with the coordinating nurse in the postoperative period to install the BEAUTIFY application on the patient's smartphone and to train her to record any Patients will monitor their symptoms weekly. In case of toxicity grade > 2, the nurse will contact the patient for further information. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient compliance with the program | Yes/No: study will be considered feasible if at least 80% of patients complete the program | End of study (12 months) |
| Patient satisfaction with the intervention | Yes/No: study will be considered feasible if at least 80% of patients are satisfied. | End of study (12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance with completing the BEAUTIFY application | % of weeks where information is recorded out of the total number of weeks | End of study (12 months) |
| Patient quality of life following surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric Fiteni | CHU de Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes | Nîmes | France |
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|
European Organisation For Research And Treatment Of Cancer Quality of Life of Cancer Patients (EORTC QLQ C30): score of 1-7 for each item
| Baseline |
| Patient quality of life following surgery | EORTC QLQ C30: score of 1-7 for each item | 1 month |
| Patient quality of life following surgery | EORTC QLQ C30: score of 1-7 for each item | 3 months |
| Patient quality of life following surgery | EORTC QLQ C30: score of 1-7 for each item | 6 months |
| Satisfaction of patients with their care | EORTC PATSAT-C33: score 0-100 | 1 month |
| Satisfaction of patients with their care | EORTC PATSAT-C33: score 0-100 | 3 months |
| Satisfaction of patients with their care | EORTC PATSAT-C33: score 0-100 | 6 months |
| Rate of post-operative complications | % patients with a complication noted in medical file | 6 months |
| Type of post-operative complications | List of the complications affected patients as noted in medical file | 6 months |
| Readmission rate for surgical or medical reason | % patients readmitted | 6 months |
| Return to work and/or social activities | Date: Patients contacted by email or telephone | 1 year |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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