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

NCT ID: NCT03300349

Last Updated: 2018-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

276 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-27

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer Lymphedema Shoulder Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Fulfillment of a preventive programme

Intervention Type OTHER

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

No fulfillment of a preventive programme

Intervention Type OTHER

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.

Fulfillment of a preventive programme

Intervention Type OTHER

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

No fulfillment of a preventive programme

Intervention Type OTHER

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 interventions assigned to this group

No fulfillment of a preventive programme

Patients who do not fulfil a preventive programme for axillary lymphadenectomy sequels

No interventions assigned to this group

Interventions

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Fulfillment of a preventive programme

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario 12 de Octubre

OTHER

Sponsor Role collaborator

University of Castilla-La Mancha

OTHER

Sponsor Role collaborator

Puerta de Hierro University Hospital

OTHER

Sponsor Role collaborator

Complejo Hospitalario Universitario de Cartagena

UNKNOWN

Sponsor Role collaborator

Violeta Pajero Otero

OTHER

Sponsor Role lead

Responsible Party

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Violeta Pajero Otero

Physiotherapist at the Mammary Pathology Unit

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Violeta Pajero Otero, MRes

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 de Octubre

Locations

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Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status

Complejo Hospitalario Universitario de Cartagena

Cartagena, Murcia, Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Castilla-La Mancha University

Toledo, , Spain

Site Status

Countries

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Spain

Other Identifiers

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InveCuidRh001

Identifier Type: -

Identifier Source: org_study_id

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