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

Completed

• Conditions: Breast Cancer Lymphedema; Shoulder Injury
• Interventions: Other: Fulfillment of a preventive programme; Other: No fulfillment of a preventive programme

• Registration Number: NCT03300349
• Lead Sponsor: Violeta Pajero Otero

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 Timeline

• Study Start: 2017-09-27
• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-09-28
• Study First Posted: 2017-10-03
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 276

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
axillary lymphadenectomy sequels	No fulfillment of a preventive programme	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	Fulfillment of a preventive programme	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.
No axillary lymphadenectomy sequels	No fulfillment of a preventive programme	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.
axillary lymphadenectomy sequels	Fulfillment of a preventive programme	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

Primary Outcome Measures

Name	Time	Method
breast cancer-related lymphedema	The agreed date with the participant for the evaluation (second half of 2017)	Truncated cone formula

Secondary Outcome Measures

Name	Time	Method
functional shoulder limitation	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	The agreed date with the participant for the evaluation (second half of 2017)	Visual Analogic Scale

Trial Locations

Locations (5)

Complejo Hospitalario Universitario de Cartagena; 🇪🇸 Cartagena, Murcia, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Castilla-La Mancha University; 🇪🇸 Toledo, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain