Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial
Identifieur interne : 001124 ( Main/Exploration ); précédent : 001123; suivant : 001125Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial
Auteurs : Margaret L. Mcneely ; Kristin L. Campbell ; Marc Webster [Canada] ; Urve Kuusk ; Karen Tracey ; John MackeySource :
- BMC Cancer [ 1471-2407 ] ; 2016.
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 9th, 2014 (
Url:
DOI: 10.1186/s12885-016-2648-8
PubMed: 27491361
PubMed Central: 4973542
Affiliations:
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Mcneely</name><affiliation><nlm:aff id="Aff1">Department of Physical Therapy, University of Alberta & Cross Cancer Institute, 2-50 Corbett Hall, Edmonton, Alberta T6G 2G4 Canada</nlm:aff><wicri:noCountry code="subfield">Alberta T6G 2G4 Canada</wicri:noCountry></affiliation></author><author><name sortKey="Campbell, Kristin L" sort="Campbell, Kristin L" uniqKey="Campbell K" first="Kristin L." last="Campbell">Kristin L. Campbell</name><affiliation><nlm:aff id="Aff2">Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia Canada</nlm:aff><wicri:noCountry code="subfield">British Columbia Canada</wicri:noCountry></affiliation></author><author><name sortKey="Webster, Marc" sort="Webster, Marc" uniqKey="Webster M" first="Marc" last="Webster">Marc Webster</name><affiliation wicri:level="4"><nlm:aff id="Aff3">Medical Oncology, Tom Baker Cancer Centre, Alberta Health Services & Department of Oncology, University of Calgary, Calgary, Alberta Canada</nlm:aff><orgName type="university">Université de Calgary</orgName><country>Canada</country><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Kuusk, Urve" sort="Kuusk, Urve" uniqKey="Kuusk U" first="Urve" last="Kuusk">Urve Kuusk</name><affiliation><nlm:aff id="Aff4">Department of Surgery, Faculty of Medicine, University of British Columbia & British Columbia Cancer Agency, Vancouver, British Columbia Canada</nlm:aff><wicri:noCountry code="subfield">British Columbia Canada</wicri:noCountry></affiliation></author><author><name sortKey="Tracey, Karen" sort="Tracey, Karen" uniqKey="Tracey K" first="Karen" last="Tracey">Karen Tracey</name><affiliation><nlm:aff id="Aff5">Clinical Trials Unit, Cross Cancer Institute, Alberta Health Services, Edmonton, Alberta Canada</nlm:aff><wicri:noCountry code="subfield">Alberta Canada</wicri:noCountry></affiliation></author><author><name sortKey="Mackey, John" sort="Mackey, John" uniqKey="Mackey J" first="John" last="Mackey">John Mackey</name><affiliation><nlm:aff id="Aff6">Medical Oncology, Cross Cancer Institute, Alberta Health Services & Department of Oncology, University of Alberta, Edmonton, Alberta Canada</nlm:aff><wicri:noCountry code="subfield">Alberta Canada</wicri:noCountry></affiliation></author></analytic><series><title level="j">BMC Cancer</title><idno type="eISSN">1471-2407</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>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.</p></sec><sec><title>Methods/Design</title><p>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.</p></sec><sec><title>Discussion</title><p>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.</p></sec><sec><title>Trial registration</title><p>This trial was registered at clinicaltrials.gov on July 9<sup>th</sup>, 2014 (<ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02187289?term=lymphedema+and+night+compression&rank=3">NCT02187289</ext-link>)</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Velanovich, V" uniqKey="Velanovich V">V Velanovich</name></author><author><name sortKey="Szymanski, W" uniqKey="Szymanski W">W Szymanski</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Disipio, T" uniqKey="Disipio T">T DiSipio</name></author><author><name sortKey="Rye, S" uniqKey="Rye S">S Rye</name></author><author><name sortKey="Newman, B" uniqKey="Newman B">B Newman</name></author><author><name sortKey="Hayes, S" uniqKey="Hayes S">S 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Hobbs</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Canada</li></country><region><li>Alberta</li></region><settlement><li>Calgary</li></settlement><orgName><li>Université de Calgary</li></orgName></list><tree><noCountry><name sortKey="Campbell, Kristin L" sort="Campbell, Kristin L" uniqKey="Campbell K" first="Kristin L." last="Campbell">Kristin L. Campbell</name><name sortKey="Kuusk, Urve" sort="Kuusk, Urve" uniqKey="Kuusk U" first="Urve" last="Kuusk">Urve Kuusk</name><name sortKey="Mackey, John" sort="Mackey, John" uniqKey="Mackey J" first="John" last="Mackey">John Mackey</name><name sortKey="Mcneely, Margaret L" sort="Mcneely, Margaret L" uniqKey="Mcneely M" first="Margaret L." last="Mcneely">Margaret L. Mcneely</name><name sortKey="Tracey, Karen" sort="Tracey, Karen" uniqKey="Tracey K" first="Karen" last="Tracey">Karen Tracey</name></noCountry><country name="Canada"><region name="Alberta"><name sortKey="Webster, Marc" sort="Webster, Marc" uniqKey="Webster M" first="Marc" last="Webster">Marc Webster</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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