Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial

BMC Cancer

Study Protocol

Karen Tracey¹  Margaret L. McNeely²  Kristin L. Campbell³  Urve Kuusk⁴  John Mackey⁵  Marc Webster⁶ 

[1] Clinical Trials Unit, Cross Cancer Institute, Alberta Health Services, Edmonton, Alberta, Canada;Department of Physical Therapy, University of Alberta & Cross Cancer Institute, 2-50 Corbett Hall, T6G 2G4, Edmonton, Alberta, Canada;Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada;Department of Surgery, Faculty of Medicine, University of British Columbia & British Columbia Cancer Agency, Vancouver, British Columbia, Canada;Medical Oncology, Cross Cancer Institute, Alberta Health Services & Department of Oncology, University of Alberta, Edmonton, Alberta, Canada;Medical Oncology, Tom Baker Cancer Centre, Alberta Health Services & Department of Oncology, University of Calgary, Calgary, Alberta, Canada;

关键词: Breast cancer;    Lymphedema;    Compression therapy;    Physical therapy;   

DOI  :  10.1186/s12885-016-2648-8

 received in 2015-10-05, accepted in 2016-07-28,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundLymphedema 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.Methods/DesignThe 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.DiscussionThe 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.Trial registrationThis trial was registered at clinicaltrials.gov on July 9th, 2014 (NCT02187289)

【 授权许可】

CC BY   
© The Author(s). 2016