LymphedemaV1, Main, Exploration, bibRecord, 000F00

Living well after breast cancer randomized controlled trial protocol: evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancer

Identifieur interne : 000F00 ( Main/Exploration ); précédent : 000E99; suivant : 000F01

Living well after breast cancer randomized controlled trial protocol: evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancer

Auteurs : Marina M. Reeves [Australie] ; Caroline O. Terranova [Australie] ; Jane M. Erickson [Australie] ; Jennifer R. Job [Australie] ; Denise S. K. Brookes [Australie] ; Nicole Mccarthy [Australie] ; Ingrid J. Hickman [Australie] ; Sheleigh P. Lawler [Australie] ; Brianna S. Fjeldsoe [Australie] ; Genevieve N. Healy [Australie] ; Elisabeth A. H. Winkler [Australie] ; Monika Janda [Australie] ; J. Lennert Veerman [Australie] ; Robert S. Ware [Australie] ; Johannes B. Prins [Australie] ; Theo Vos [États-Unis] ; Wendy Demark-Wahnefried [États-Unis] ; Elizabeth G. Eakin [Australie]

Source :

BMC Cancer [ 1471-2407 ] ; 2016.

RBID : PMC:5086071

Abstract

Background

Obesity, physical inactivity and poor diet quality have been associated with increased risk of breast cancer-specific and all-cause mortality as well as treatment-related side-effects in breast cancer survivors. Weight loss intervention trials in breast cancer survivors have shown that weight loss is safe and achievable; however, few studies have examined the benefits of such interventions on a broad range of outcomes and few have examined factors important to translation (e.g. feasible delivery method for scaling up, assessment of sustained changes, cost-effectiveness). The Living Well after Breast Cancer randomized controlled trial aims to evaluate a 12-month telephone-delivered weight loss intervention (versus usual care) on weight change and a range of secondary outcomes including cost-effectiveness.

Methods/design

Women (18–75 years; body mass index 25–45 kg/m²) diagnosed with stage I-III breast cancer in the previous 2 years are recruited from public and private hospitals and through the state-based cancer registry (target n = 156). Following baseline assessment, participants are randomized 1:1 to either a 12-month telephone-delivered weight loss intervention (targeting diet and physical activity) or usual care. Data are collected at baseline, 6-months (mid-intervention), 12-months (end-of-intervention) and 18-months (maintenance). The primary outcome is change in weight at 12-months. Secondary outcomes are changes in body composition, bone mineral density, cardio-metabolic and cancer-related biomarkers, metabolic health and chronic disease risk, physical function, patient-reported outcomes (quality of life, fatigue, menopausal symptoms, body image, fear of cancer recurrence) and behaviors (dietary intake, physical activity, sitting time). Data collected at 18-months will be used to assess whether outcomes achieved at end-of-intervention are sustained six months after intervention completion. Cost-effectiveness will be assessed, as will mediators and moderators of intervention effects.

Discussion

This trial will provide evidence needed to inform the wide-scale provision of weight loss, physical activity and dietary interventions as part of routine survivorship care for breast cancer survivors.

Trial registration

Australian and New Zealand Clinical Trial Registry (ANZCTR) - ACTRN12612000997853 (Registered 18 September 2012).

Electronic supplementary material

The online version of this article (doi:10.1186/s12885-016-2858-0) contains supplementary material, which is available to authorized users.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5086071

DOI: 10.1186/s12885-016-2858-0
PubMed: 27793125
PubMed Central: 5086071

Affiliations:

Le document en format XML

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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Institute for Health Metrics and Evaluation, University of Washington, Seattle</wicri:regionArea>
<orgName type="university">Université de Washington</orgName>
<placeName><settlement type="city">Seattle</settlement>
<region type="state">Washington (État)</region>
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<author><name sortKey="Demark Wahnefried, Wendy" sort="Demark Wahnefried, Wendy" uniqKey="Demark Wahnefried W" first="Wendy" last="Demark-Wahnefried">Wendy Demark-Wahnefried</name>
<affiliation wicri:level="3"><nlm:aff id="Aff10">Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham</wicri:regionArea>
<placeName><settlement type="city">Birmingham</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Midlands de l'Ouest</region>
</placeName>
</affiliation>
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<author><name sortKey="Eakin, Elizabeth G" sort="Eakin, Elizabeth G" uniqKey="Eakin E" first="Elizabeth G." last="Eakin">Elizabeth G. Eakin</name>
<affiliation wicri:level="1"><nlm:aff id="Aff1">School of Public Health, The University of Queensland, Brisbane, Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>School of Public Health, The University of Queensland, Brisbane</wicri:regionArea>
<wicri:noRegion>Brisbane</wicri:noRegion>
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</analytic>
<series><title level="j">BMC Cancer</title>
<idno type="eISSN">1471-2407</idno>
<imprint><date when="2016">2016</date>
</imprint>
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Obesity, physical inactivity and poor diet quality have been associated with increased risk of breast cancer-specific and all-cause mortality as well as treatment-related side-effects in breast cancer survivors. Weight loss intervention trials in breast cancer survivors have shown that weight loss is safe and achievable; however, few studies have examined the benefits of such interventions on a broad range of outcomes and few have examined factors important to translation (e.g. feasible delivery method for scaling up, assessment of sustained changes, cost-effectiveness). The Living Well after Breast Cancer randomized controlled trial aims to evaluate a 12-month telephone-delivered weight loss intervention (versus usual care) on weight change and a range of secondary outcomes including cost-effectiveness.</p>
</sec>
<sec><title>Methods/design</title>
<p>Women (18–75 years; body mass index 25–45 kg/m<sup>2</sup>
) diagnosed with stage I-III breast cancer in the previous 2 years are recruited from public and private hospitals and through the state-based cancer registry (target <italic>n</italic>
 = 156). Following baseline assessment, participants are randomized 1:1 to either a 12-month telephone-delivered weight loss intervention (targeting diet and physical activity) or usual care. Data are collected at baseline, 6-months (mid-intervention), 12-months (end-of-intervention) and 18-months (maintenance). The primary outcome is change in weight at 12-months. Secondary outcomes are changes in body composition, bone mineral density, cardio-metabolic and cancer-related biomarkers, metabolic health and chronic disease risk, physical function, patient-reported outcomes (quality of life, fatigue, menopausal symptoms, body image, fear of cancer recurrence) and behaviors (dietary intake, physical activity, sitting time). Data collected at 18-months will be used to assess whether outcomes achieved at end-of-intervention are sustained six months after intervention completion. Cost-effectiveness will be assessed, as will mediators and moderators of intervention effects.</p>
</sec>
<sec><title>Discussion</title>
<p>This trial will provide evidence needed to inform the wide-scale provision of weight loss, physical activity and dietary interventions as part of routine survivorship care for breast cancer survivors.</p>
</sec>
<sec><title>Trial registration</title>
<p>Australian and New Zealand Clinical Trial Registry (ANZCTR) - <ext-link ext-link-type="uri" xlink:href="https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363035&isReview=true">ACTRN12612000997853</ext-link>
 (Registered 18 September 2012).</p>
</sec>
<sec><title>Electronic supplementary material</title>
<p>The online version of this article (doi:10.1186/s12885-016-2858-0) contains supplementary material, which is available to authorized users.</p>
</sec>
</div>
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Living well after breast cancer randomized controlled trial protocol: evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancer

Living well after breast cancer randomized controlled trial protocol: evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancer

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