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

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT04444882
Collaborator
(none)
71
1
7.9
9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    71 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Complications After Lumpectomy, Sentinel Node and Radiotherapy in Breast Cancer Patients and Physiotherapy Care
    Actual Study Start Date :
    Jun 1, 2021
    Actual Primary Completion Date :
    Jan 28, 2022
    Actual Study Completion Date :
    Jan 28, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu Grenoble Alpes Grenoble Cedex 9 France 38043

    Sponsors and Collaborators

    • University Hospital, Grenoble

    Investigators

    • Study Director: Caroline Bordin-Goffin, IFMK Saint Martin d'Hères

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT04444882
    Other Study ID Numbers:
    • 38RC20.120
    • 2020-A00966-33
    First Posted:
    Jun 24, 2020
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Grenoble
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2022