Multidisciplinary Care Pathway With Electronic Patient Reported Outcomes (ePRO) Post-operative Follow-up of Breast Cancer Surgery Complications to Optimize Patient Quality of Life (BEAUTIFY-3)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: BEAUTIFY application

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BEAUTIFY application	Device: BEAUTIFY 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.

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Frédéric Fiteni, CHU de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): February 16, 2024
• Study Completion (Actual): February 16, 2024

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; mastectomy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Prix Ruban Rose/2020/FF-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No