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

Breast Cancer Clinical Trial

— BEAUTIFY-3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05449340
• Other study ID #: Prix Ruban Rose/2020/FF-03
• Status: Completed
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: February 16, 2024

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 16, 2024
• Est. primary completion date: February 16, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Compliance with completing the BEAUTIFY application	% of weeks where information is recorded out of the total number of weeks	End of study (12 months)
Secondary	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
Secondary	Patient quality of life following surgery	EORTC QLQ C30: score of 1-7 for each item	1 month
Secondary	Patient quality of life following surgery	EORTC QLQ C30: score of 1-7 for each item	3 months
Secondary	Patient quality of life following surgery	EORTC QLQ C30: score of 1-7 for each item	6 months
Secondary	Satisfaction of patients with their care	EORTC PATSAT-C33: score 0-100	1 month
Secondary	Satisfaction of patients with their care	EORTC PATSAT-C33: score 0-100	3 months
Secondary	Satisfaction of patients with their care	EORTC PATSAT-C33: score 0-100	6 months
Secondary	Rate of post-operative complications	% patients with a complication noted in medical file	6 months
Secondary	Type of post-operative complications	List of the complications affected patients as noted in medical file	6 months
Secondary	Readmission rate for surgical or medical reason	% patients readmitted	6 months
Secondary	Return to work and/or social activities	Date: Patients contacted by email or telephone	1 year