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

NCT05449340 | Completed

• 1 other identifier: Prix Ruban Rose/2020/FF-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

mastectomy; quality of life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Compliance with completing the BEAUTIFY application

  End of study (12 months)

• Patient quality of life following surgery

  Baseline

• Patient quality of life following surgery

  1 month

• Patient quality of life following surgery

  3 months

• Patient quality of life following surgery

  6 months

Study Arms (1)

BEAUTIFY application

EXPERIMENTAL

Device: BEAUTIFY application

Interventions

BEAUTIFY application DEVICE

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.

BEAUTIFY application

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Frédéric Fiteni

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 8, 2022
• Study Start: July 25, 2022
• Primary Completion: February 16, 2024
• Study Completion: February 16, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

FR (1)