Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial.
Identifieur interne : 000677 ( PubMed/Corpus ); précédent : 000676; suivant : 000678Efficacy 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 ; 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.
DOI: 10.1186/s12885-016-2648-8
PubMed: 27491361
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial.</title><author><name sortKey="Mcneely, Margaret L" sort="Mcneely, Margaret L" uniqKey="Mcneely M" first="Margaret L" last="Mcneely">Margaret L. Mcneely</name><affiliation><nlm:affiliation>Department of Physical Therapy, University of Alberta & Cross Cancer Institute, 2-50 Corbett Hall, Edmonton, Alberta, T6G 2G4, Canada. mmcneely@ualberta.ca.</nlm:affiliation></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:affiliation>Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Webster, Marc" sort="Webster, Marc" uniqKey="Webster M" first="Marc" last="Webster">Marc Webster</name><affiliation><nlm:affiliation>Medical Oncology, Tom Baker Cancer Centre, Alberta Health Services & Department of Oncology, University of Calgary, Calgary, Alberta, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Kuusk, Urve" sort="Kuusk, Urve" uniqKey="Kuusk U" first="Urve" last="Kuusk">Urve Kuusk</name><affiliation><nlm:affiliation>Department of Surgery, Faculty of Medicine, University of British Columbia & British Columbia Cancer Agency, Vancouver, British Columbia, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Tracey, Karen" sort="Tracey, Karen" uniqKey="Tracey K" first="Karen" last="Tracey">Karen Tracey</name><affiliation><nlm:affiliation>Clinical Trials Unit, Cross Cancer Institute, Alberta Health Services, Edmonton, Alberta, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Mackey, John" sort="Mackey, John" uniqKey="Mackey J" first="John" last="Mackey">John Mackey</name><affiliation><nlm:affiliation>Medical Oncology, Cross Cancer Institute, Alberta Health Services & Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:27491361</idno><idno type="pmid">27491361</idno><idno type="doi">10.1186/s12885-016-2648-8</idno><idno type="wicri:Area/PubMed/Corpus">000677</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000677</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial.</title><author><name sortKey="Mcneely, Margaret L" sort="Mcneely, Margaret L" uniqKey="Mcneely M" first="Margaret L" last="Mcneely">Margaret L. Mcneely</name><affiliation><nlm:affiliation>Department of Physical Therapy, University of Alberta & Cross Cancer Institute, 2-50 Corbett Hall, Edmonton, Alberta, T6G 2G4, Canada. mmcneely@ualberta.ca.</nlm:affiliation></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:affiliation>Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Webster, Marc" sort="Webster, Marc" uniqKey="Webster M" first="Marc" last="Webster">Marc Webster</name><affiliation><nlm:affiliation>Medical Oncology, Tom Baker Cancer Centre, Alberta Health Services & Department of Oncology, University of Calgary, Calgary, Alberta, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Kuusk, Urve" sort="Kuusk, Urve" uniqKey="Kuusk U" first="Urve" last="Kuusk">Urve Kuusk</name><affiliation><nlm:affiliation>Department of Surgery, Faculty of Medicine, University of British Columbia & British Columbia Cancer Agency, Vancouver, British Columbia, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Tracey, Karen" sort="Tracey, Karen" uniqKey="Tracey K" first="Karen" last="Tracey">Karen Tracey</name><affiliation><nlm:affiliation>Clinical Trials Unit, Cross Cancer Institute, Alberta Health Services, Edmonton, Alberta, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Mackey, John" sort="Mackey, John" uniqKey="Mackey J" first="John" last="Mackey">John Mackey</name><affiliation><nlm:affiliation>Medical Oncology, Cross Cancer Institute, Alberta Health Services & Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.</nlm:affiliation></affiliation></author></analytic><series><title level="j">BMC cancer</title><idno type="eISSN">1471-2407</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">27491361</PMID><DateCreated><Year>2016</Year><Month>08</Month><Day>05</Day></DateCreated><DateRevised><Year>2017</Year><Month>04</Month><Day>10</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1471-2407</ISSN><JournalIssue CitedMedium="Internet"><Volume>16</Volume><PubDate><Year>2016</Year><Month>Aug</Month><Day>04</Day></PubDate></JournalIssue><Title>BMC cancer</Title><ISOAbbreviation>BMC Cancer</ISOAbbreviation></Journal><ArticleTitle>Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial.</ArticleTitle><Pagination><MedlinePgn>601</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s12885-016-2648-8</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">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.</AbstractText><AbstractText Label="METHODS/DESIGN" NlmCategory="METHODS">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.</AbstractText><AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">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.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">This trial was registered at clinicaltrials.gov on July 9(th), 2014 ( NCT02187289 ).</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>McNeely</LastName><ForeName>Margaret L</ForeName><Initials>ML</Initials><AffiliationInfo><Affiliation>Department of Physical Therapy, University of Alberta & Cross Cancer Institute, 2-50 Corbett Hall, Edmonton, Alberta, T6G 2G4, Canada. mmcneely@ualberta.ca.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Campbell</LastName><ForeName>Kristin L</ForeName><Initials>KL</Initials><AffiliationInfo><Affiliation>Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Webster</LastName><ForeName>Marc</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Medical Oncology, Tom Baker Cancer Centre, Alberta Health Services & Department of Oncology, University of Calgary, Calgary, Alberta, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kuusk</LastName><ForeName>Urve</ForeName><Initials>U</Initials><AffiliationInfo><Affiliation>Department of Surgery, Faculty of Medicine, University of British Columbia & British Columbia Cancer Agency, Vancouver, British Columbia, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tracey</LastName><ForeName>Karen</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Clinical Trials Unit, Cross Cancer Institute, Alberta Health Services, Edmonton, Alberta, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mackey</LastName><ForeName>John</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Medical Oncology, Cross Cancer Institute, Alberta Health Services & Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT02187289</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>08</Month><Day>04</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>BMC Cancer</MedlineTA><NlmUniqueID>100967800</NlmUniqueID><ISSNLinking>1471-2407</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>J Clin Oncol. 2012 Oct 20;30(30):3726-33</RefSource><PMID Version="1">23008299</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lymphat Res Biol. 2005;3(4):208-17</RefSource><PMID Version="1">16379589</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>CMAJ. 2001 Jan 23;164(2):191-9</RefSource><PMID Version="1">11332311</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Cancer. 2012 Apr 15;118(8 Suppl):2300-11</RefSource><PMID Version="1">22488704</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Clin Oncol. 2008 Jul 20;26(21):3536-42</RefSource><PMID Version="1">18640935</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet Oncol. 2013 May;14(6):500-15</RefSource><PMID Version="1">23540561</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Support Care Cancer. 2011 Jul;19(7):935-40</RefSource><PMID Version="1">20495983</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>PM R. 2012 Aug;4(8):580-601</RefSource><PMID Version="1">22920313</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1436-43</RefSource><PMID Version="1">20605339</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lymphology. 2003 Jun;36(2):84-91</RefSource><PMID Version="1">12926833</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Am J Surg. 1999 Mar;177(3):184-7; 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