Clinical trial NCT04957186: Personalized Follow-up After Breast Cancer Surgery Via Electronic Patient Reported Outcomes
Official title: Development of a Multidisciplinary Care Pathway With Postoperative Follow-up Via Electronic Patient Reported Outcomes (ePRO) of Complications of Breast Cancer Surgery to Optimise Patients' Quality of Life.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Patient Reported Outcomes
Mastectomy
Postoperative Complications
Quality of Life
Breast Cancer
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups in this study : one "Focus group" consisting of 10 patients who have undergone breast cancer surgery (tumorectomy, mastectomy, lymph node dissection), and one group of 10 caregivers consisting of 3 surgeons, 3 algologists, 3 oncologists and one study coordinator.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Based on one focus group of caregivers and one group of patients treated by surgery for breast cancer this study is an attempt to identify the specific needs of this population and then develop the BEAUTIFY care pathway.This study aims to build a new multidisciplinary care pathway (BEAUTIFY = BrEast cAncer qUaliTy of lIfe aFter surgerY) with post-operative follow-up via electronic patient-reported outcomes of breast cancer surgery complications in order to optimize the quality of life of patients.

Detailed description: This study aims to build a new multidisciplinary care pathway (BEAUTIFY = BrEast cAncer qUaliTy of lIfe aFter surgerY) with post-operative follow-up via electronic patient-reported outcomes of breast cancer surgery complications in order to optimise the quality of life of patients.

The study will use focus groups of caregivers and patients treated by surgery for breast cancer to identify the specific needs of this population and then develop the BEAUTIFY care pathway.

In oncology, the monitoring of symptoms and treatment toxicities by caregivers is most often done through hetero-assessments. However, caregivers tend to underestimate them in relation to what the patient is experiencing. The discrepancy between the measures of side-effects recorded by the doctor's and patient's measures of side effects has indeed been demonstrated many times. For the patient's own view of his or her symptoms, health symptoms, health status, or quality of life (QoL), the (QoL), Patient Reported Outcomes (PRO) are increasingly used in oncology. They are defined as "any measure of the patient's health status reported directly by the patient, without interpretation by the physician or a third person". Several clinical trials have been conducted in recent years to assess the feasibility and value of collecting PROs in clinical routine in oncology, particularly through the use of electronic objects (ePROS). Improvements have been shown in the overall survival and QoL of patients followed by ePROS compared to conventionally followed patients, in patients on chemotherapy for metastatic cancer and in lung cancer surveillance.

Breast cancer surgery is responsible for specific acute (infection, haematoma, pain) and chronic (breast pain, axillary pain, arm pain, allodynia, paresthesia, retractile capsulitis of the shoulder post-mastectomy syndrome). Acute infections Post-operative infections may occur in 3 to 19% of 2020 RUBAN ROSE patients, especially after mastectomy. Chronic pain is reported in up to 70% of patients depending on the series. Post-mastectomy syndrome affects 20 to 50% of patients. These complications may be increased by radiotherapy. Many studies have shown that all of these chronic complications have a negative impact on the quality of life of patients and are responsible for depression and/or anxiety, sleep disorders and difficulties in returning to work.

Nevertheless, there are specific treatments (PEC) that can reduce these symptoms: physiotherapy, analgesic medication, analgesic patches, botulinum toxin injections, psychotherapy, etc. Several studies have shown that the earlier this treatment is undertaken, the lower the risk of complications.

It is therefore necessary to detect these complications as early as possible in order to manage them as quickly as possible. A close follow-up of specific symptoms of breast cancer surgery complications by ePRO could lead to earlier detection and management of these complications and thus improve patients' pain and quality of life (QoL).

We propose to develop an original care pathway focused on the collection of post-surgery complications in breast cancer via ePROs. The BEAUTIFY programme will be built by a committee of experts on the basis of reflections carried out within 2 focus groups: a group of 10 patients treated at Nîmes University Hospital for breast cancer; a group of caregivers from the University Hospitals of Nîmes, Montpellier and the ICM.

Eligibility criteria: Inclusion Criteria:

* Female adult patients recruited from the gynecological or medical oncology department at Nîmes University Hospital who have undergone breast cancer surgery at least 6 months previous to their inclusion in the study and recruited during their post-operative follow-up consultations.
* All patients must have given written informed consent.

Exclusion Criteria:

* Patients who have not undergone breast cancer surgery.
* Patients Under the age of 18.
* Patients who have not given written informed consent.

Primary outcomes:
measure: Specific needs of patients who have undergone breast cancer surgery : ePRO results
timeFrame: Up to 1 month following the end of radiotherapy treatment
measure: Use of ePROs as a means of collecting post-surgical complications
timeFrame: Up to 1 month following the end of radiotherapy treatment
measure: Results of the interview with the nurse for collecting post-surgical complications
timeFrame: Up to 1 month following the end of radiotherapy treatment
measure: Actions desired in the event of an onset of complications in patients who have undergone breast cancer surgery.
timeFrame: Up to 1 month following the end of radiotherapy treatment
measure: Degree of anxiety/reassurance of patients who have undergone breast cancer surgery.
timeFrame: Up to 1 month following the end of radiotherapy treatment
measure: Expectations of patients who have undergone breast cancer surgery.
timeFrame: Up to 1 month following the end of radiotherapy treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Nîmes University Hospital
state: Gard
Study officials:
References:
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