Breast Cancer
Conditions
Keywords
mastectomy, quality of life
Brief summary
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.
Interventions
DEVICEBEAUTIFY application
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.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Breast cancer patient scheduled for surgery * Patient able to use a connected electronic object and having a tablet or a smartphone with internet access at home. * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan
Exclusion criteria
* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study * The subject unable to express consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient compliance with the program | End of study (12 months) | Yes/No: study will be considered feasible if at least 80% of patients complete the program |
| Patient satisfaction with the intervention | End of study (12 months) | Yes/No: study will be considered feasible if at least 80% of patients are satisfied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of patients with their care | 1 month | EORTC PATSAT-C33: score 0-100 |
| Rate of post-operative complications | 6 months | % patients with a complication noted in medical file |
| Compliance with completing the BEAUTIFY application | End of study (12 months) | % of weeks where information is recorded out of the total number of weeks |
| Readmission rate for surgical or medical reason | 6 months | % patients readmitted |
| Return to work and/or social activities | 1 year | Date: Patients contacted by email or telephone |
| Type of post-operative complications | 6 months | List of the complications affected patients as noted in medical file |
| Patient quality of life following surgery | Baseline | European Organisation For Research And Treatment Of Cancer Quality of Life of Cancer Patients (EORTC QLQ C30): score of 1-7 for each item |
Countries
France
Outcome results
None listed