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

Centre Hospitalier Universitaire de Nīmes50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Nîmes

Nîmes, France

Outcomes

Primary Outcomes

Patient compliance with the program

Yes/No: study will be considered feasible if at least 80% of patients complete the program

Time frame: 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.

Time frame: End of study (12 months)

Secondary Outcomes

Compliance with completing the BEAUTIFY application

% of weeks where information is recorded out of the total number of weeks

Time frame: 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

Time frame: Baseline

Patient quality of life following surgery

EORTC QLQ C30: score of 1-7 for each item

Time frame: 1 month

Patient quality of life following surgery

EORTC QLQ C30: score of 1-7 for each item

Time frame: 3 months

Patient quality of life following surgery

EORTC QLQ C30: score of 1-7 for each item

Time frame: 6 months

Satisfaction of patients with their care

EORTC PATSAT-C33: score 0-100

Time frame: 1 month

Satisfaction of patients with their care

EORTC PATSAT-C33: score 0-100

Time frame: 3 months

Satisfaction of patients with their care

EORTC PATSAT-C33: score 0-100

Time frame: 6 months

Rate of post-operative complications

% patients with a complication noted in medical file

Time frame: 6 months

Type of post-operative complications

List of the complications affected patients as noted in medical file

Time frame: 6 months

Readmission rate for surgical or medical reason

% patients readmitted

Time frame: 6 months

Return to work and/or social activities

Date: Patients contacted by email or telephone

Time frame: 1 year

Data from ClinicalTrials.gov

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