Complications After Lumpectomy, Sentinel Node and Radiotherapy in Breast Cancer Patients and Physiotherapy Care

Completed

• Conditions: Breast Neoplasm

• Registration Number: NCT04444882
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

To make an inventory of the physiotherapeutic care and the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment.

The investigators expect to see a lack of consultation of physiotherapists by patients despite a significant number of complications, impacting the quality of life.

Detailed Description

This study is observational and descriptive. For this purpose, patients meeting the inclusion and non-inclusion criteria can answer, if they wish, to an online questionnaire after having read the information and non-opposition letter.

Study Timeline

• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Study Start: 2021-06-01
• Primary Completion: 2022-01-28
• Study Completion: 2022-01-28
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

Inclusion Criteria

• Volunteer Patients
• Patients with a good command of French in order to understand the letter of information and the questionnaire.
• Patients treated at the "Couple Enfant Hospital" in Grenoble. We have chosen to take patients who have been operated on at least 3 months ago (average time of end of radiotherapy).

Exclusion Criteria

• Patient having undergone a mastectomy or chemotherapy
• Patient with difficulties understanding, expressing or reading the French language
• Vulnerable patient or patient with impaired cognitive capacities (dementia, confusion)
• Patient subject to a legal protection measure or out of state to express her opposition (guardianship, curatorship)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inventory of the physiotherapeutic care of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment	10 minutes	Answers to the questionnaire part 2 "physiotherapy care". Questions 17, 18, 19, 20, 21, 22, 24, 25, 26. (étude descriptive)

Secondary Outcome Measures

Name	Time	Method
Description of the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment	10 minutes	Answers to the questionnaire part 2 " post-operative complications " Questions 16, 23, 27, 28.

Trial Locations

Locations (1)

Chu Grenoble Alpes; 🇫🇷 Grenoble Cedex 9, France