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The Women’s wellness after cancer program: a multisite, single-blinded, randomised controlled trial protocol

Identifieur interne : 000112 ( Main/Exploration ); précédent : 000111; suivant : 000113

The Women’s wellness after cancer program: a multisite, single-blinded, randomised controlled trial protocol

Auteurs : Debra Anderson ; Charrlotte Seib ; Dian Tjondronegoro ; Jane Turner ; Leanne Monterosso ; Amanda Mcguire ; Janine Porter-Steele ; Wei Song [République populaire de Chine] ; Patsy Yates ; Neil King ; Leonie Young ; Kate White ; Kathryn Lee [États-Unis] ; Sonj Hall ; Mei Krishnasamy ; Kathy Wells ; Sarah Balaam ; Alexandra L. Mccarthy

Source :

RBID : PMC:5292002

Abstract

Background

Despite advances in cancer diagnosis and treatment have significantly improved survival rates, patients post-treatment-related health needs are often not adequately addressed by current health services. The aim of the Women’s Wellness after Cancer Program (WWACP), which is a digitised multimodal lifestyle intervention, is to enhance health-related quality of life in women previously treated for blood, breast and gynaecological cancers.

Methods

A single-blinded, multi-centre randomized controlled trial recruited a total of 330 women within 24 months of completion of chemotherapy (primary or adjuvant) and/or radiotherapy. Women were randomly assigned to either usual care or intervention using computer-generated permuted-block randomisation. The intervention comprises an evidence-based interactive iBook and journal, web interface, and virtual health consultations by an experienced cancer nurse trained in the delivery of the WWACP. The 12 week intervention focuses on evidence-based health education and health promotion after a cancer diagnosis. Components are drawn from the American Cancer Research Institute and the World Cancer Research Fund Guidelines (2010), incorporating promotion of physical activity, good diet, smoking cessation, reduction of alcohol intake, plus strategies for sleep and stress management. The program is based on Bandura’s social cognitive theoretical framework. The primary outcome is health-related quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G). Secondary outcomes are menopausal symptoms as assessed by Greene Climacteric Scale; physical activity elicited with the Physical Activity Questionnaire Short Form (IPAQ-SF); sleep measured by the Pittsburgh Sleep Quality Index; habitual dietary intake monitored with the Food Frequency Questionnaire (FFQ); alcohol intake and tobacco use measured by the Australian Health Survey and anthropometric measures including height, weight and waist-to-hip ratio. All participants were assessed with these measures at baseline (at the start of the intervention), 12 weeks (at completion of the intervention), and 24 months (to determine the level of sustained behaviour change). Further, a simultaneous cost-effectiveness evaluation will consider if the WWACP provides value for money and will be reported separately.

Discussion

Women treated for blood, breast and gynaecological cancers demonstrate increasingly good survival rates. However, they experience residual health problems that are potentially modifiable through behavioural lifestyle interventions such as the WWACP.

Trial registration

The protocol for this study was registered with the Australian and New Zealand Clinical Trials Registry, Trial ID: ACTRN12614000800628, July 28, 2014.


Url:
DOI: 10.1186/s12885-017-3088-9
PubMed: 28159005
PubMed Central: 5292002


Affiliations:


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<name sortKey="Porter Steele, Janine" sort="Porter Steele, Janine" uniqKey="Porter Steele J" first="Janine" last="Porter-Steele">Janine Porter-Steele</name>
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<nlm:aff id="Aff1">
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<institution></institution>
<institution>Menzies Health Institute Queensland, Griffith University, Menzies Health Institute Queensland,</institution>
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Parklands Drive, Southport, Queensland 4215 Australia</nlm:aff>
<wicri:noCountry code="subfield">Queensland 4215 Australia</wicri:noCountry>
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<affiliation>
<nlm:aff id="Aff2">
<institution-wrap>
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<institution>Institute of Health and Biomedical Innovation,</institution>
<institution>Queensland University of Technology,</institution>
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Brisbane, Queensland Australia</nlm:aff>
<wicri:noCountry code="subfield">Queensland Australia</wicri:noCountry>
</affiliation>
<affiliation>
<nlm:aff id="Aff7">
<institution-wrap>
<institution-id institution-id-type="ISNI">0000 0004 0627 7561</institution-id>
<institution-id institution-id-type="GRID">grid.417021.1</institution-id>
<institution></institution>
<institution>Choices Cancer Support Program, Wesley Hospital,</institution>
</institution-wrap>
Brisbane, Queensland Australia</nlm:aff>
<wicri:noCountry code="subfield">Queensland Australia</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Song, Wei" sort="Song, Wei" uniqKey="Song W" first="Wei" last="Song">Wei Song</name>
<affiliation wicri:level="1">
<nlm:aff id="Aff8">
<institution-wrap>
<institution-id institution-id-type="ISNI">0000 0000 9833 2433</institution-id>
<institution-id institution-id-type="GRID">grid.412514.7</institution-id>
<institution></institution>
<institution>Shanghai Ocean University,</institution>
</institution-wrap>
Shanghai, China</nlm:aff>
<country xml:lang="fr">République populaire de Chine</country>
<wicri:regionArea>Shanghai</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Yates, Patsy" sort="Yates, Patsy" uniqKey="Yates P" first="Patsy" last="Yates">Patsy Yates</name>
<affiliation>
<nlm:aff id="Aff2">
<institution-wrap>
<institution-id institution-id-type="ISNI">0000000089150953</institution-id>
<institution-id institution-id-type="GRID">grid.1024.7</institution-id>
<institution>Institute of Health and Biomedical Innovation,</institution>
<institution>Queensland University of Technology,</institution>
</institution-wrap>
Brisbane, Queensland Australia</nlm:aff>
<wicri:noCountry code="subfield">Queensland Australia</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="King, Neil" sort="King, Neil" uniqKey="King N" first="Neil" last="King">Neil King</name>
<affiliation>
<nlm:aff id="Aff2">
<institution-wrap>
<institution-id institution-id-type="ISNI">0000000089150953</institution-id>
<institution-id institution-id-type="GRID">grid.1024.7</institution-id>
<institution>Institute of Health and Biomedical Innovation,</institution>
<institution>Queensland University of Technology,</institution>
</institution-wrap>
Brisbane, Queensland Australia</nlm:aff>
<wicri:noCountry code="subfield">Queensland Australia</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Young, Leonie" sort="Young, Leonie" uniqKey="Young L" first="Leonie" last="Young">Leonie Young</name>
<affiliation>
<nlm:aff id="Aff7">
<institution-wrap>
<institution-id institution-id-type="ISNI">0000 0004 0627 7561</institution-id>
<institution-id institution-id-type="GRID">grid.417021.1</institution-id>
<institution></institution>
<institution>Choices Cancer Support Program, Wesley Hospital,</institution>
</institution-wrap>
Brisbane, Queensland Australia</nlm:aff>
<wicri:noCountry code="subfield">Queensland Australia</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="White, Kate" sort="White, Kate" uniqKey="White K" first="Kate" last="White">Kate White</name>
<affiliation>
<nlm:aff id="Aff9">
<institution-wrap>
<institution-id institution-id-type="ISNI">0000 0004 1936 834X</institution-id>
<institution-id institution-id-type="GRID">grid.1013.3</institution-id>
<institution></institution>
<institution>University of Sydney,</institution>
</institution-wrap>
Sydney, New South Wales Australia</nlm:aff>
<wicri:noCountry code="subfield">New South Wales Australia</wicri:noCountry>
</affiliation>
<affiliation>
<nlm:aff id="Aff10">
<institution-wrap>
<institution-id institution-id-type="ISNI">0000 0004 0385 0051</institution-id>
<institution-id institution-id-type="GRID">grid.413249.9</institution-id>
<institution></institution>
<institution>Royal Prince Alfred Hospital,</institution>
</institution-wrap>
Sydney, New South Wales Australia</nlm:aff>
<wicri:noCountry code="subfield">New South Wales Australia</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Lee, Kathryn" sort="Lee, Kathryn" uniqKey="Lee K" first="Kathryn" last="Lee">Kathryn Lee</name>
<affiliation wicri:level="2">
<nlm:aff id="Aff11">University of California San Francisco, California, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of California San Francisco, California</wicri:regionArea>
<placeName>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Hall, Sonj" sort="Hall, Sonj" uniqKey="Hall S" first="Sonj" last="Hall">Sonj Hall</name>
<affiliation>
<nlm:aff id="Aff12">
<institution-wrap>
<institution-id institution-id-type="ISNI">0000 0001 2193 0854</institution-id>
<institution-id institution-id-type="GRID">grid.1023.0</institution-id>
<institution></institution>
<institution>Central Queensland University,</institution>
</institution-wrap>
Brisbane, Queensland Australia</nlm:aff>
<wicri:noCountry code="subfield">Queensland Australia</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Krishnasamy, Mei" sort="Krishnasamy, Mei" uniqKey="Krishnasamy M" first="Mei" last="Krishnasamy">Mei Krishnasamy</name>
<affiliation>
<nlm:aff id="Aff13">
<institution-wrap>
<institution-id institution-id-type="ISNI">0000000403978434</institution-id>
<institution-id institution-id-type="GRID">grid.1055.1</institution-id>
<institution></institution>
<institution>Peter MacCallum Cancer Institute,</institution>
</institution-wrap>
Melbourne, Victoria Australia</nlm:aff>
<wicri:noCountry code="subfield">Victoria Australia</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Wells, Kathy" sort="Wells, Kathy" uniqKey="Wells K" first="Kathy" last="Wells">Kathy Wells</name>
<affiliation>
<nlm:aff id="Aff14">Breast Cancer Network Australia, Melbourne, Victoria Australia</nlm:aff>
<wicri:noCountry code="subfield">Victoria Australia</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Balaam, Sarah" sort="Balaam, Sarah" uniqKey="Balaam S" first="Sarah" last="Balaam">Sarah Balaam</name>
<affiliation>
<nlm:aff id="Aff2">
<institution-wrap>
<institution-id institution-id-type="ISNI">0000000089150953</institution-id>
<institution-id institution-id-type="GRID">grid.1024.7</institution-id>
<institution>Institute of Health and Biomedical Innovation,</institution>
<institution>Queensland University of Technology,</institution>
</institution-wrap>
Brisbane, Queensland Australia</nlm:aff>
<wicri:noCountry code="subfield">Queensland Australia</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Mccarthy, Alexandra L" sort="Mccarthy, Alexandra L" uniqKey="Mccarthy A" first="Alexandra L." last="Mccarthy">Alexandra L. Mccarthy</name>
<affiliation>
<nlm:aff id="Aff15">
<institution-wrap>
<institution-id institution-id-type="ISNI">0000 0004 0380 2017</institution-id>
<institution-id institution-id-type="GRID">grid.412744.0</institution-id>
<institution></institution>
<institution>Division of Cancer Services, Princess Alexandra Hospital,</institution>
</institution-wrap>
Brisbane, Queensland Australia</nlm:aff>
<wicri:noCountry code="subfield">Queensland Australia</wicri:noCountry>
</affiliation>
<affiliation>
<nlm:aff id="Aff2">
<institution-wrap>
<institution-id institution-id-type="ISNI">0000000089150953</institution-id>
<institution-id institution-id-type="GRID">grid.1024.7</institution-id>
<institution>Institute of Health and Biomedical Innovation,</institution>
<institution>Queensland University of Technology,</institution>
</institution-wrap>
Brisbane, Queensland Australia</nlm:aff>
<wicri:noCountry code="subfield">Queensland Australia</wicri:noCountry>
</affiliation>
</author>
</analytic>
<series>
<title level="j">BMC Cancer</title>
<idno type="eISSN">1471-2407</idno>
<imprint>
<date when="2017">2017</date>
</imprint>
</series>
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<front>
<div type="abstract" xml:lang="en">
<sec>
<title>Background</title>
<p>Despite advances in cancer diagnosis and treatment have significantly improved survival rates, patients post-treatment-related health needs are often not adequately addressed by current health services. The aim of the Women’s Wellness after Cancer Program (WWACP), which is a digitised multimodal lifestyle intervention, is to enhance health-related quality of life in women previously treated for blood, breast and gynaecological cancers.</p>
</sec>
<sec>
<title>Methods</title>
<p>A single-blinded, multi-centre randomized controlled trial recruited a total of 330 women within 24 months of completion of chemotherapy (primary or adjuvant) and/or radiotherapy. Women were randomly assigned to either usual care or intervention using computer-generated permuted-block randomisation. The intervention comprises an evidence-based interactive
<italic>iBook</italic>
and journal, web interface, and virtual health consultations by an experienced cancer nurse trained in the delivery of the WWACP. The 12 week intervention focuses on evidence-based health education and health promotion after a cancer diagnosis. Components are drawn from the American Cancer Research Institute and the World Cancer Research Fund Guidelines (2010), incorporating promotion of physical activity, good diet, smoking cessation, reduction of alcohol intake, plus strategies for sleep and stress management. The program is based on Bandura’s social cognitive theoretical framework. The primary outcome is health-related quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G). Secondary outcomes are menopausal symptoms as assessed by Greene Climacteric Scale; physical activity elicited with the Physical Activity Questionnaire Short Form (IPAQ-SF); sleep measured by the Pittsburgh Sleep Quality Index; habitual dietary intake monitored with the Food Frequency Questionnaire (FFQ); alcohol intake and tobacco use measured by the Australian Health Survey and anthropometric measures including height, weight and waist-to-hip ratio. All participants were assessed with these measures at baseline (at the start of the intervention), 12 weeks (at completion of the intervention), and 24 months (to determine the level of sustained behaviour change). Further, a simultaneous cost-effectiveness evaluation will consider if the WWACP provides value for money and will be reported separately.</p>
</sec>
<sec>
<title>Discussion</title>
<p>Women treated for blood, breast and gynaecological cancers demonstrate increasingly good survival rates. However, they experience residual health problems that are potentially modifiable through behavioural lifestyle interventions such as the WWACP.</p>
</sec>
<sec>
<title>Trial registration</title>
<p>The protocol for this study was registered with the Australian and New Zealand Clinical Trials Registry, Trial ID:
<ext-link ext-link-type="uri" xlink:href="http://www.anzctr.org.au/">ACTRN12614000800628</ext-link>
, July 28, 2014.</p>
</sec>
</div>
</front>
<back>
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<li>Californie</li>
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<name sortKey="Hall, Sonj" sort="Hall, Sonj" uniqKey="Hall S" first="Sonj" last="Hall">Sonj Hall</name>
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<name sortKey="Krishnasamy, Mei" sort="Krishnasamy, Mei" uniqKey="Krishnasamy M" first="Mei" last="Krishnasamy">Mei Krishnasamy</name>
<name sortKey="Mccarthy, Alexandra L" sort="Mccarthy, Alexandra L" uniqKey="Mccarthy A" first="Alexandra L." last="Mccarthy">Alexandra L. Mccarthy</name>
<name sortKey="Mcguire, Amanda" sort="Mcguire, Amanda" uniqKey="Mcguire A" first="Amanda" last="Mcguire">Amanda Mcguire</name>
<name sortKey="Monterosso, Leanne" sort="Monterosso, Leanne" uniqKey="Monterosso L" first="Leanne" last="Monterosso">Leanne Monterosso</name>
<name sortKey="Porter Steele, Janine" sort="Porter Steele, Janine" uniqKey="Porter Steele J" first="Janine" last="Porter-Steele">Janine Porter-Steele</name>
<name sortKey="Seib, Charrlotte" sort="Seib, Charrlotte" uniqKey="Seib C" first="Charrlotte" last="Seib">Charrlotte Seib</name>
<name sortKey="Tjondronegoro, Dian" sort="Tjondronegoro, Dian" uniqKey="Tjondronegoro D" first="Dian" last="Tjondronegoro">Dian Tjondronegoro</name>
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<name sortKey="Wells, Kathy" sort="Wells, Kathy" uniqKey="Wells K" first="Kathy" last="Wells">Kathy Wells</name>
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