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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03300349
Recruitment Status : Completed
First Posted : October 3, 2017
Last Update Posted : February 23, 2018
Sponsor:
Collaborators:
Hospital Universitario 12 de Octubre
University of Castilla-La Mancha
Puerta de Hierro University Hospital
Complejo Hospitalario Universitario de Cartagena
Information provided by (Responsible Party):
Violeta Pajero Otero, Hospital Universitario 12 de Octubre

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.

Condition or disease Intervention/treatment
Breast Cancer Lymphedema Shoulder Injury Other: Fulfillment of a preventive programme Other: No fulfillment of a preventive programme

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.

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Study Type : Observational
Actual Enrollment : 276 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Interhospital Variability in Programmes to Prevent Axillary Lymphadenectomy Sequels in Breast Cancer Patients.
Actual Study Start Date : September 27, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. breast cancer-related lymphedema [ Time Frame: The agreed date with the participant for the evaluation (second half of 2017) ]
    Truncated cone formula


Secondary Outcome Measures :
  1. functional shoulder limitation [ Time Frame: The agreed date with the participant for the evaluation (second half of 2017) ]
    Shoulder Pain and Disability Index

  2. 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


Other Outcome Measures:
  1. Degree of compliance with the prevention program [ Time Frame: The agreed date with the participant for the evaluation (second half of 2017) ]
    questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women suffering from axillary lymphadenectomy due to breast cancer in four spanish hospitals
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300349


Locations
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Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Complejo Hospitalario Universitario de Cartagena
Cartagena, Murcia, Spain, 30203
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Castilla-La Mancha University
Toledo, Spain, 45071
Sponsors and Collaborators
Violeta Pajero Otero
Hospital Universitario 12 de Octubre
University of Castilla-La Mancha
Puerta de Hierro University Hospital
Complejo Hospitalario Universitario de Cartagena
Investigators
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Principal Investigator: Violeta Pajero Otero, MRes Hospital Universitario 12 de Octubre
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Responsible Party: Violeta Pajero Otero, Physiotherapist at the Mammary Pathology Unit, Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier: NCT03300349    
Other Study ID Numbers: InveCuidRh001
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Violeta Pajero Otero, Hospital Universitario 12 de Octubre:
Breast cancer
Breast cancer-related lymphedema
Shoulder injury
Prevention
Educational activity
Physiotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Shoulder Injuries
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Wounds and Injuries
Postoperative Complications
Pathologic Processes