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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: BEAUTIFY application

• Registration Number: NCT05449340
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-07-04
• Study First Posted: 2022-07-08
• Study Start: 2022-07-25
• Status Verified: 2024-02
• Primary Completion: 2024-02-16
• Study Completion: 2024-02-16
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BEAUTIFY application	BEAUTIFY application	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Compliance with completing the BEAUTIFY application	End of study (12 months)	% of weeks where information is recorded out of the total number of weeks
Patient quality of life following surgery	6 months	EORTC QLQ C30: score of 1-7 for each item
Satisfaction of patients with their care	6 months	EORTC PATSAT-C33: score 0-100
Rate of post-operative complications	6 months	% patients with a complication noted in medical file
Type of post-operative complications	6 months	List of the complications affected patients as noted in medical file
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

Trial Locations

Locations (1)

CHU de Nîmes; 🇫🇷 Nîmes, France