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

Abstract

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)

Preventing Early Postoperative Arm Swelling and Lymphedema Manifestation by Compression Sleeves After Axillary Lymph Node Interventions in Breast Cancer Patients: A Randomized Controlled Trial

“…This treatment requires lifelong management and the effectiveness depends on patient compliance. 29,30 Most studies in LE management are flawed by the fact that in addition to compression, several other components of DLT, especially MLD 31 are used. In our study, both patient groups had the same additional training program shown to be beneficial after lymph node intervention, 31 but no other additional components of DLT.…”

Systematic rapid "living" review on rehabilitation needs due to COVID-19: update to March 31st, 2020

“…based instrument, was used to assess quality of life as a primary outcome in their examination of the efficacy of night-time compression on arm lymphedema volume maintenance in breast cancer survivors. 27 One challenge researchers face when reporting a study is deciding which ICF-based patient characteristics to include and report in rehabilitation studies. To facilitate this decision, researchers in rehabilitation can rely on established ICF sets, such as the ICF Generic-7 and -30 Sets and ICF Core Sets.…”

How to use the International Classification of Functioning, Disability and Health as a reference system for comparative evaluation and standardized reporting of rehabilitation interventions

“…11 The ICF not only makes the reporting of both clinical and population health data in an internationally comparative manner possible, the ICF as the operationalization of functioning also allows for the differentiation between a person's intrinsic biological health capacity and lived health. 4,5,12 Most importantly the ICF enables data sharing across a wide range of application areas in research, including clinical trials, [13][14][15][16] registries and cohort studies, 17,18 and in developing data collection instruments and methodologies. [18][19][20] Despite the universal understanding that functioning information, operationalized through the ICF, is the "core concept underpinning" research in rehabilitation 3 , no concrete recommendations on how to use the ICF in rehabilitation research exist to date.…”

“…mobility, pain). 15 ICF sets have also been shown to be useful in defining functioning outcomes beyond rehabilitation studies. For example, in a multicentre cross-sectional study a questionnaire containing categories of the ICF-CS for head and neck cancer was used as one of the outcome instruments to compare functional outcome in patients with advanced head and neck cancer treated with a) surgical resection and reconstruction with microvascular free flaps followed by radiochemotherapy versus b) primary radiochemotherapy.…”