Clinical trial NCT05449340: Multidisciplinary Care Pathway With Electronic Patient Reported Outcomes (ePRO) Post-operative Follow-up of Breast Cancer Surgery Complications to Optimize Patient Quality of Life
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: mastectomy
quality of life
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Patient compliance with the program
timeFrame: End of study (12 months)
measure: Patient satisfaction with the intervention
timeFrame: End of study (12 months)
Secondary outcomes:
measure: Compliance with completing the BEAUTIFY application
timeFrame: End of study (12 months)
measure: Patient quality of life following surgery
timeFrame: Baseline
measure: Patient quality of life following surgery
timeFrame: 1 month
measure: Patient quality of life following surgery
timeFrame: 3 months
measure: Patient quality of life following surgery
timeFrame: 6 months
measure: Satisfaction of patients with their care
timeFrame: 1 month
measure: Satisfaction of patients with their care
timeFrame: 3 months
measure: Satisfaction of patients with their care
timeFrame: 6 months
measure: Rate of post-operative complications
timeFrame: 6 months
measure: Type of post-operative complications
timeFrame: 6 months
measure: Readmission rate for surgical or medical reason
timeFrame: 6 months
measure: Return to work and/or social activities
timeFrame: 1 year
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: CHU de Nimes
name: Frédéric Fiteni
role: PRINCIPAL_INVESTIGATOR
References: