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

NCT04957186 | Completed DMC

• 1 other identifier: Prix Ruban Rose/2021/FF-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Patient Reported Outcomes; Mastectomy; Postoperative Complications; Quality of Life; Breast Cancer

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Patient Focus Group

ACTIVE COMPARATOR

Group consisting of 10 patients who have undergone breast cancer surgery (tumorectomy, mastectomy, lymph node dissection).

Other: Collection of postoperative information

Caregiver Focus Group

ACTIVE COMPARATOR

Group consisting of 10 caregivers composed of 3 surgeons, 3 algologists, 3 oncologists and one study coordinator.

Other: Analysis of postoperative information collected from patients

Interventions

Collection of postoperative information OTHER

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.

Patient Focus Group

Analysis of postoperative information collected from patients OTHER

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.

Caregiver Focus Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must have given written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Nîmes University Hospital

Nîmes, Gard, 30029, France

Location

Related Publications (6)

• 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.

  PMID: 26787278 BACKGROUND

• 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.

  PMID: 28586821 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 28861642 BACKGROUND

• 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.

  PMID: 26720497 BACKGROUND

• 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.

  PMID: 22510674 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 12, 2021
• Study Start: April 1, 2021
• Primary Completion: May 31, 2021
• Study Completion: June 30, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

FR (1)