- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03300349
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
-
-
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Madrid, Spain, 28034
- Hospital Universitario Ramon Y Cajal
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Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre
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Toledo, Spain, 45071
- Castilla-La Mancha University
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Madrid
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Majadahonda, Madrid, Spain, 28222
- Hospital Universitario Puerta de Hierro
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Murcia
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Cartagena, Murcia, Spain, 30203
- Complejo Hospitalario Universitario de Cartagena
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-
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
|
Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder
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.
|
Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder
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.
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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