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

NCT04444882 | Completed

• 2 other identifiers: 38RC20.1202020-A00966-33
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm

Keywords

postoperative complications; physiotherapy; rehabilitation; lumpectomy; sentinel node; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Description of the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment

  10 minutes

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study involves breast cancer patients who have undergone the following treatment: lumpectomy, sentinel node and radiotherapy.

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

Location

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 Officials

• Caroline Bordin-Goffin

  IFMK Saint Martin d'Hères

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 24, 2020
• Study Start: June 1, 2021
• Primary Completion: January 28, 2022
• Study Completion: January 28, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)