title: Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial.
abstract: Lymphedema is a prevalent long-term effect of breast cancer treatment that is associated with reduced quality of life. More recent observational data suggest that the addition of night-time compression to day-time use of a compression garment results in better long-term control of arm lymphedema. The primary objectives of the randomized controlled phase of the trial are to determine the efficacy of night-time compression on arm lymphedema volume maintenance and quality of life in breast cancer survivors who have completed intensive reduction treatment for their lymphedema.
  
  
  
  The study will be a parallel 3-arm, multi-centre randomized fast-track trial. A total of 120 women with breast cancer related lymphedema will be recruited from 3 centres in Canada and randomized to group 1: Day-time compression garment alone or Group 2: Day-time compression garment + night-time compression bandaging or Group 3: Day-time compression garment + use of a night-time compression system garment. The duration of the primary intervention period will be 12 weeks. The follow-up period after the intervention (weeks 13 to 24) will follow a longitudinal observational design. The primary outcome variables: differences from baseline to week 12 in arm volume and quality of life (Lymphoedema Functioning, Disability and Health Questionnaire: Lymph-ICF). Secondary outcomes include bioimpedance analysis, sleep disturbance and self-efficacy. All measurements are standardized and will be performed prior to randomization, and at weeks 6, 12, 18 and 24.
  
  
  
  The use of night-time compression as a self-management strategy for chronic breast cancer related lymphedema is seen as an innovative approach to improve long-term control over the condition. This trial aims to advance the knowledge on self-management strategies for lymphedema.
  
  
  
  This trial was registered at clinicaltrials.gov on July 9(th), 2014 ( NCT02187289 ).
authors.affiliation: Department of Physical Therapy, University of Alberta & Cross Cancer Institute, 2-50 Corbett Hall, Edmonton, Alberta, T6G 2G4, Canada. mmcneely@ualberta.ca.
authors.forename: Margaret L
authors.initials: ML
authors.lastname: McNeely
authors.affiliation: Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: Kristin L
authors.initials: KL
authors.lastname: Campbell
authors.affiliation: Medical Oncology, Tom Baker Cancer Centre, Alberta Health Services & Department of Oncology, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Marc
authors.initials: M
authors.lastname: Webster
authors.affiliation: Department of Surgery, Faculty of Medicine, University of British Columbia & British Columbia Cancer Agency, Vancouver, British Columbia, Canada.
authors.forename: Urve
authors.initials: U
authors.lastname: Kuusk
authors.affiliation: Clinical Trials Unit, Cross Cancer Institute, Alberta Health Services, Edmonton, Alberta, Canada.
authors.forename: Karen
authors.initials: K
authors.lastname: Tracey
authors.affiliation: Medical Oncology, Cross Cancer Institute, Alberta Health Services & Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Mackey
mesh_terms: D000072656:Breast Cancer Lymphedema / Q000628:therapy*; D058128:Compression Bandages; D005260:Female; D006801:Humans; D012107:Research Design
keywords: Breast cancer; Compression therapy; Lymphedema; Physical therapy