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

Breast Neoplasm Clinical Trial

— COTUKI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04444882
• Other study ID #: 38RC20.120
• Secondary ID: 2020-A00966-33
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: January 28, 2022

Study information

• Verified date: August 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	Grenoble Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inventory of the physiotherapeutic care of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment	Answers to the questionnaire part 2 "physiotherapy care". Questions 17, 18, 19, 20, 21, 22, 24, 25, 26. (étude descriptive)	10 minutes
Secondary	Description of the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment	Answers to the questionnaire part 2 " post-operative complications " Questions 16, 23, 27, 28.	10 minutes