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)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
BEAUTIFY application
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring mastectomy, quality of life
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
- Patient with an indication for adjuvant chemotherapy.
Sites / Locations
- CHU de NîmesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BEAUTIFY application
Arm Description
Outcomes
Primary Outcome Measures
Patient compliance with the program
Yes/No: study will be considered feasible if at least 80% of patients complete the program
Patient satisfaction with the intervention
Yes/No: study will be considered feasible if at least 80% of patients are satisfied.
Secondary Outcome Measures
Compliance with completing the BEAUTIFY application
% of weeks where information is recorded out of the total number of weeks
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
Patient quality of life following surgery
EORTC QLQ C30: score of 1-7 for each item
Patient quality of life following surgery
EORTC QLQ C30: score of 1-7 for each item
Patient quality of life following surgery
EORTC QLQ C30: score of 1-7 for each item
Satisfaction of patients with their care
EORTC PATSAT-C33: score 0-100
Satisfaction of patients with their care
EORTC PATSAT-C33: score 0-100
Satisfaction of patients with their care
EORTC PATSAT-C33: score 0-100
Rate of post-operative complications
% patients with a complication noted in medical file
Type of post-operative complications
List of the complications affected patients as noted in medical file
Readmission rate for surgical or medical reason
% patients readmitted
Return to work and/or social activities
Date: Patients contacted by email or telephone
Full Information
NCT ID
NCT05449340
First Posted
June 27, 2022
Last Updated
May 26, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT05449340
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
mastectomy, quality of life
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BEAUTIFY application
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
BEAUTIFY application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient compliance with the program
Description
Yes/No: study will be considered feasible if at least 80% of patients complete the program
Time Frame
End of study (12 months)
Title
Patient satisfaction with the intervention
Description
Yes/No: study will be considered feasible if at least 80% of patients are satisfied.
Time Frame
End of study (12 months)
Secondary Outcome Measure Information:
Title
Compliance with completing the BEAUTIFY application
Description
% of weeks where information is recorded out of the total number of weeks
Time Frame
End of study (12 months)
Title
Patient quality of life following surgery
Description
European Organisation For Research And Treatment Of Cancer Quality of Life of Cancer Patients (EORTC QLQ C30): score of 1-7 for each item
Time Frame
Baseline
Title
Patient quality of life following surgery
Description
EORTC QLQ C30: score of 1-7 for each item
Time Frame
1 month
Title
Patient quality of life following surgery
Description
EORTC QLQ C30: score of 1-7 for each item
Time Frame
3 months
Title
Patient quality of life following surgery
Description
EORTC QLQ C30: score of 1-7 for each item
Time Frame
6 months
Title
Satisfaction of patients with their care
Description
EORTC PATSAT-C33: score 0-100
Time Frame
1 month
Title
Satisfaction of patients with their care
Description
EORTC PATSAT-C33: score 0-100
Time Frame
3 months
Title
Satisfaction of patients with their care
Description
EORTC PATSAT-C33: score 0-100
Time Frame
6 months
Title
Rate of post-operative complications
Description
% patients with a complication noted in medical file
Time Frame
6 months
Title
Type of post-operative complications
Description
List of the complications affected patients as noted in medical file
Time Frame
6 months
Title
Readmission rate for surgical or medical reason
Description
% patients readmitted
Time Frame
6 months
Title
Return to work and/or social activities
Description
Date: Patients contacted by email or telephone
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frédéric Fiteni
Phone
04.34.03.46.69
Email
frederic.fiteni@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Fiteni
Organizational Affiliation
CHU de Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
04.66.68.42.36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Frederic Fiteni
First Name & Middle Initial & Last Name & Degree
Catherine Ferrer
First Name & Middle Initial & Last Name & Degree
Florent Masia
First Name & Middle Initial & Last Name & Degree
Olivier Bredeau
12. IPD Sharing Statement
Learn more about this trial
Multidisciplinary Care Pathway With Electronic Patient Reported Outcomes (ePRO) Post-operative Follow-up of Breast Cancer Surgery Complications to Optimize Patient Quality of Life
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