Interhospital Variability in Programmes to Prevent Axillary Lymphadenectomy Sequels in Breast Cancer Patients.

ID: NCT03300349
Status: Completed
Phase: N/A
Start Date: September 27, 2017
First Submitted: September 28, 2017
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: Violeta Pajero Otero, Hospital Universitario 12 de Octubre, University of Castilla-La Mancha, Puerta de Hierro University Hospital and 1 more..
Location: Spain
Conditions: Breast Cancer Lymphedema, Shoulder Injury
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Study Description

Brief Summary

This study aims to determine the effectiveness of the different programmes of four Spanish hospitals about prevention of axillary lymphadenectomy sequels in breast cancer patients.

Detailed Description

This study aims to describe the different programs for the prevention of sequels of axillary lymphadenectomy in patients with breast cancer in four Spanish hospitals, to determine the degree of compliance of these programs and to register the frecuency of lymphedema and limitation of mobility of the upper limb in breast cancer patients undergoing axillary lymphadenectomy between 2014 and 2016 in the four hospitals.
Condition or disease Intervention/treatment Phase

Breast Cancer Lymphedema

Shoulder Injury

Other: Fulfillment of a preventive programme
Other Names
Other: No fulfillment of a preventive programme
Other Names
N/A

Tracking Information

First Submitted DateSeptember 28, 2017
Last Update Posted DateFebruary 22, 2018
Actual Start DateSeptember 27, 2017
Actual Completion DateDecember 31, 2017
Actual Primary Completion DateDecember 31, 2017
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • breast cancer-related lymphedema [Time Frame: The agreed date with the participant for the evaluation (second half of 2017)]

    Truncated cone formula

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • functional shoulder limitation [Time Frame: The agreed date with the participant for the evaluation (second half of 2017)]

    Shoulder Pain and Disability Index

  • Symptoms associated with breast cancer-related lymphedema [Time Frame: The agreed date with the participant for the evaluation (second half of 2017)]

    Visual Analogic Scale

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleInterhospital Variability in Programmes to Prevent Axillary Lymphadenectomy Sequels in Breast Cancer Patients.
Official TitleInterhospital Variability in Programmes to Prevent Axillary Lymphadenectomy Sequels in Breast Cancer Patients.
Brief Summary

This study aims to determine the effectiveness of the different programmes of four Spanish hospitals about prevention of axillary lymphadenectomy sequels in breast cancer patients.

Detailed Description

This study aims to describe the different programs for the prevention of sequels of axillary lymphadenectomy in patients with breast cancer in four Spanish hospitals, to determine the degree of compliance of these programs and to register the frecuency of lymphedema and limitation of mobility of the upper limb in breast cancer patients undergoing axillary lymphadenectomy between 2014 and 2016 in the four hospitals.

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
276
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Breast Cancer Lymphedema
Shoulder Injury
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodProbability Sample
Study PopulationWomen suffering from axillary lymphadenectomy due to breast cancer in four spanish hospitals
Intervention
Other: Fulfillment of a preventive programme

Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder

Other Names
Other: No fulfillment of a preventive programme

No fulfillment of the preventive programme: Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder

Other Names
Study Groups/Cohorts
axillary lymphadenectomy sequels
Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have developed breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme

No axillary lymphadenectomy sequels
Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have not develped breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme.

Fulfillment of a preventive programme
Patients who fulfil a preventive programme for axillary lymphadenectomy sequels

No fulfillment of a preventive programme
Patients who do not fulfil a preventive programme for axillary lymphadenectomy sequels

Study Arms
axillary lymphadenectomy sequels
Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have developed breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme
Other : Fulfillment of a preventive programme
Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder

axillary lymphadenectomy sequels
Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have developed breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme
Other : No fulfillment of a preventive programme
No fulfillment of the preventive programme: Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder

No axillary lymphadenectomy sequels
Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have not develped breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme.
Other : No fulfillment of a preventive programme
No fulfillment of the preventive programme: Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder

No axillary lymphadenectomy sequels
Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have not develped breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme.
Other : Fulfillment of a preventive programme
Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder

Arm Intervention/Treatment
axillary lymphadenectomy sequels
Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have developed breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme
Other : Fulfillment of a preventive programme
axillary lymphadenectomy sequels
Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have developed breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme
Other : No fulfillment of a preventive programme
No axillary lymphadenectomy sequels
Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have not develped breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme.
Other : No fulfillment of a preventive programme
No axillary lymphadenectomy sequels
Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have not develped breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme.
Other : Fulfillment of a preventive programme

Recruitment Information

Recruitment Status:Completed
Enrollment276
Completion DateDecember 31, 2017
Eligibility Criteria: Inclusion Criteria:
- Suffering from axillary lymphadenectomy due to breast cancer treatment between 1 january 2014 until 31 december 2016.

Exclusion Criteria:
- Lymphedema prior to surgery in any of the upper limbs or any malformation or injury that prevents comparison of both upper limb volumes.
- Cognitive impairment or intellectual disability that would prevent understanding the instructions of the study, as well as the purpose of the same.
- Serious condition.
GenderFemale
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Spain

Administrative Information

NCT Number:NCT03300349
Other Study ID Numbers
InveCuidRh001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyVioleta Pajero Otero, Hospital Universitario 12 de Octubre
Study Sponsor
Violeta Pajero Otero
Collaborators
Hospital Universitario 12 de Octubre
University of Castilla-La Mancha
Puerta de Hierro University Hospital
Complejo Hospitalario Universitario de Cartagena
Investigators
Principal Investigator
Violeta Pajero Otero, MRes
Hospital Universitario 12 de Octubre