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

February 22, 2018 updated by: Violeta Pajero Otero
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

276

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Toledo, Spain, 45071
        • Castilla-La Mancha University
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro
    • Murcia
      • Cartagena, Murcia, Spain, 30203
        • Complejo Hospitalario Universitario de Cartagena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women suffering from axillary lymphadenectomy due to breast cancer in four spanish hospitals

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
breast cancer-related lymphedema
Time Frame: The agreed date with the participant for the evaluation (second half of 2017)
Truncated cone formula
The agreed date with the participant for the evaluation (second half of 2017)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional shoulder limitation
Time Frame: The agreed date with the participant for the evaluation (second half of 2017)
Shoulder Pain and Disability Index
The agreed date with the participant for the evaluation (second half of 2017)
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
The agreed date with the participant for the evaluation (second half of 2017)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of compliance with the prevention program
Time Frame: The agreed date with the participant for the evaluation (second half of 2017)
questionnaire
The agreed date with the participant for the evaluation (second half of 2017)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Violeta Pajero Otero

Collaborators

Hospital Universitario 12 de Octubre
Puerta de Hierro University Hospital
University of Castilla-La Mancha
Complejo Hospitalario Universitario de Cartagena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2017

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

September 28, 2017

First Submitted That Met QC Criteria

September 28, 2017

First Posted (Actual)

October 3, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InveCuidRh001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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