Clinical trial NCT03300349: Interhospital Variability in Programmes to Prevent Axillary Lymphadenectomy Sequels in Breast Cancer Patients.
Official title: Interhospital Variability in Programmes to Prevent Axillary Lymphadenectomy Sequels in Breast Cancer Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Lymphedema
Shoulder Injury
Keywords: Breast cancer
Breast cancer-related lymphedema
Shoulder injury
Prevention
Educational activity
Physiotherapy
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
Collaborators: name: Hospital Universitario 12 de Octubre
name: University of Castilla-La Mancha
name: Puerta de Hierro University Hospital
name: Complejo Hospitalario Universitario de Cartagena
First posted: 2017-10-03
Enrollment: 276
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women suffering from axillary lymphadenectomy due to breast cancer in four spanish hospitals

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.

Eligibility 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.

Primary outcomes:
measure: breast cancer-related lymphedema
timeFrame: The agreed date with the participant for the evaluation (second half of 2017)
Secondary outcomes:
measure: functional shoulder limitation
timeFrame: The agreed date with the participant for the evaluation (second half of 2017)
measure: Symptoms associated with breast cancer-related lymphedema
timeFrame: The agreed date with the participant for the evaluation (second half of 2017)
Other outcomes:
measure: Degree of compliance with the prevention program
timeFrame: The agreed date with the participant for the evaluation (second half of 2017)
Locations:
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Cartagena
country: Spain
facility: Complejo Hospitalario Universitario de Cartagena
state: Murcia
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Toledo
country: Spain
facility: Castilla-La Mancha University
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Violeta Pajero Otero, MRes
role: PRINCIPAL_INVESTIGATOR
References: