Multidisciplinary Care Pathway With Electronic Patient Reported Outcomes (ePRO) Post-operative Follow-up of Breast Cancer Surgery Complications to Optimize Patient Quality of Life

Study Overview
=================
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.

Official Title
-----------------
Multidisciplinary Care Pathway With Electronic Patient Reported Outcomes (ePRO) Post-operative Follow-up of Breast Cancer Surgery Complications to Optimize Patient Quality of Life

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: BEAUTIFY application


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BEAUTIFY application<br> | Device: BEAUTIFY application<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mastectomy, quality of life