Personalized Follow-up After Breast Cancer Surgery Via Electronic Patient Reported Outcomes

Breast Cancer Clinical Trial

— BEAUTIFY-2  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04957186
• Other study ID #: Prix Ruban Rose/2021/FF-01
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Collection of postoperative information
The EORTC BR45 questionnaire will be used to gather information from patients regarding possible post-operative complications recorded via electronic patient-reported outcomes (pain, swelling, hypersensitivity etc.) as well as via the interviews with the state-registered coordinating nurse.
• Analysis of postoperative information collected from patients
All post-operative complications recorded via electronic patient-reported outcomes (pain, swelling, hypersensitivity etc.) as well as via the interviews with the state-registered coordinating nurse will be analyzed with the aim of proposing an appropriate care pathway.

Locations

Country	Name	City	State
France	Nîmes University Hospital	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (6)

Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156. — View Citation

Di Maio M, Basch E, Bryce J, Perrone F. Patient-reported outcomes in the evaluation of toxicity of anticancer treatments. Nat Rev Clin Oncol. 2016 May;13(5):319-25. doi: 10.1038/nrclinonc.2015.222. Epub 2016 Jan 20. Review. — View Citation

Hamood R, Hamood H, Merhasin I, Keinan-Boker L. Chronic pain and other symptoms among breast cancer survivors: prevalence, predictors, and effects on quality of life. Breast Cancer Res Treat. 2018 Jan;167(1):157-169. doi: 10.1007/s10549-017-4485-0. Epub 2017 Aug 31. — View Citation

Kitzinger J, Barbour RS.Developing Focus Group Research: Politics, Theory and Practice. SAGE 1999

Montemurro F, Mittica G, Cagnazzo C, Longo V, Berchialla P, Solinas G, Culotta P, Martinello R, Foresto M, Gallizioli S, Calori A, Grasso B, Volpone C, Bertola G, Parola G, Tealdi G, Giuliano PL, Aglietta M, Ballari AM. Self-evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer. JAMA Oncol. 2016 Apr;2(4):445-52. doi: 10.1001/jamaoncol.2015.4720. — View Citation

Scaffidi M, Vulpiani MC, Vetrano M, Conforti F, Marchetti MR, Bonifacino A, Marchetti P, Saraceni VM, Ferretti A. Early rehabilitation reduces the onset of complications in the upper limb following breast cancer surgery. Eur J Phys Rehabil Med. 2012 Dec;48(4):601-11. Epub 2012 Apr 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific needs of patients who have undergone breast cancer surgery : ePRO results	Electronic Patient Reported Outcomes (ePROs) will be used to record postoperative complications of these patients who have undergone breast cancer surgery. Patients will have to express themselves according to items 47 - 53 of the EORTC QLQ-BR45 questionnaire containing questions related to the previous Week. The patient must answer on a scale of 1 to 4 in which 1 = Not at All, 2 = A little, 3 = Quite a Bit and 4 = Very Much	Up to 1 month following the end of radiotherapy treatment
Primary	Use of ePROs as a means of collecting post-surgical complications	Patients will be asked to give their appreciation of the use of Electronic Patient Reported Outcomes (ePROs) to record their postoperative complications: time taken, frequency and the type of interface used (ePRO or telephone)	Up to 1 month following the end of radiotherapy treatment
Primary	Results of the interview with the nurse for collecting post-surgical complications	Patients will be asked to give their appreciation of the interview with the nurse to record their postoperative complications.	Up to 1 month following the end of radiotherapy treatment
Primary	Actions desired in the event of an onset of complications in patients who have undergone breast cancer surgery.	Patients will be asked to express what actions they would like to be undertaken in the event of an onset of complications.	Up to 1 month following the end of radiotherapy treatment
Primary	Degree of anxiety/reassurance of patients who have undergone breast cancer surgery.	Patients will be asked to express their degree of anxiety or reassurance following their breast cancer surgery according to a Lickert scale of 1 to 5 in which 1 = completely reassured, 2 = reassured, 3 = indifferent, 4 = anxious and 5 = extremely anxious.	Up to 1 month following the end of radiotherapy treatment
Primary	Expectations of patients who have undergone breast cancer surgery.	Patients will be asked to express their expectations of the results of this information-gathering. These will be expressed on a Lickert scale of 1 to 5 in which 1 = not very hopeful, 2 = hopeful, 3 = indifferent, 4 = very hopeful, 5 = extremely hopeful.	Up to 1 month following the end of radiotherapy treatment