Efficacy, cost-utility and reach of an eHealth self-management application 'Oncokompas' that helps cancer survivors to obtain optimal supportive care: study protocol for a randomised controlled trial
Identifieur interne : 000596 ( Main/Exploration ); précédent : 000595; suivant : 000597Efficacy, cost-utility and reach of an eHealth self-management application 'Oncokompas' that helps cancer survivors to obtain optimal supportive care: study protocol for a randomised controlled trial
Auteurs : Anja Van Der Hout [Pays-Bas] ; Cornelia F. Van Uden-Kraan [Pays-Bas] ; Birgit I. Witte [Pays-Bas] ; Veerle M. H. Coupé [Pays-Bas] ; Femke Jansen [Pays-Bas] ; C. René Leemans [Pays-Bas] ; Pim Cuijpers [Pays-Bas] ; Lonneke V. Van De Poll-Franse [Pays-Bas] ; Irma M. Verdonck-De Leeuw [Pays-Bas]Source :
- Trials [ 1745-6215 ] ; 2017.
Abstract
Cancer survivors have to deal with a wide range of physical symptoms, psychological, social and existential concerns, and lifestyle issues related to cancer and its treatment. Therefore, it is essential that they have access to optimal supportive care services. The eHealth self-management application Oncokompas was developed to support cancer survivors with where they need to turn to for advice and guidance, as well as to increase their knowledge on the availability of optimal support. A randomised controlled trial will be conducted to assess the efficacy, cost-utility and reach of Oncokompas as an eHealth self-management application compared with care as usual among cancer survivors.
Adult cancer survivors diagnosed with breast, colorectal or head and neck cancer or lymphoma who are at 3 months to 5 years since curative treatment will be included. In total, 544 cancer survivors will be randomly assigned to the intervention group or a wait-list control group. The primary outcome measure is patient activation. Secondary outcome measures include self-efficacy, personal control, perceived patient-physician interaction, need for supportive care, mental adjustment to cancer and health-related quality of life. Furthermore, cost-utility outcomes will be assessed.
In this study, we will evaluate the efficacy and cost-utility of Oncokompas among cancer survivors, as well as the reach of Oncokompas. These are essential first steps in the translation of research into practice and contribute to sustainable adoption, implementation and maintenance of an evidence-based Oncokompas.
Netherlands Trial Register identifier:
The online version of this article (doi:10.1186/s13063-017-1952-1) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/s13063-017-1952-1
PubMed: 28532439
PubMed Central: 5440906
Affiliations:
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The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Amsterdam</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0435 165X</institution-id><institution-id institution-id-type="GRID">grid.16872.3a</institution-id><institution>EMGO+ Institute for Health and Care Research,</institution><institution>Vrije Universiteit and VU University Medical Centre,</institution></institution-wrap>Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Amsterdam</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0435 165X</institution-id><institution-id institution-id-type="GRID">grid.16872.3a</institution-id><institution>Cancer Centre Amsterdam (CCA),</institution><institution>VU University Medical Centre,</institution></institution-wrap>Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Van Uden Kraan, Cornelia F" sort="Van Uden Kraan, Cornelia F" uniqKey="Van Uden Kraan C" first="Cornelia F." last="Van Uden-Kraan">Cornelia F. 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René" last="Leemans">C. René Leemans</name><affiliation wicri:level="1"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0435 165X</institution-id><institution-id institution-id-type="GRID">grid.16872.3a</institution-id><institution>Cancer Centre Amsterdam (CCA),</institution><institution>VU University Medical Centre,</institution></institution-wrap>Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Amsterdam</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff5"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0435 165X</institution-id><institution-id institution-id-type="GRID">grid.16872.3a</institution-id><institution>Department of Otolaryngology–Head and Neck Surgery,</institution><institution>VU University Medical Centre,</institution></institution-wrap>Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Cuijpers, Pim" sort="Cuijpers, Pim" uniqKey="Cuijpers P" first="Pim" last="Cuijpers">Pim Cuijpers</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1754 9227</institution-id><institution-id institution-id-type="GRID">grid.12380.38</institution-id><institution>Department of Clinical Psychology, Amsterdam Public Health Institute,</institution><institution>Vrije Universiteit Amsterdam,</institution></institution-wrap>Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Amsterdam</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0435 165X</institution-id><institution-id institution-id-type="GRID">grid.16872.3a</institution-id><institution>EMGO+ Institute for Health and Care Research,</institution><institution>Vrije Universiteit and VU University Medical Centre,</institution></institution-wrap>Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Van De Poll Franse, Lonneke V" sort="Van De Poll Franse, Lonneke V" uniqKey="Van De Poll Franse L" first="Lonneke V." last="Van De Poll-Franse">Lonneke V. Van De Poll-Franse</name><affiliation wicri:level="1"><nlm:aff id="Aff6"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0501 9982</institution-id><institution-id institution-id-type="GRID">grid.470266.1</institution-id><institution>Department of Research,</institution><institution>Netherlands Comprehensive Cancer Organisation,</institution></institution-wrap>Eindhoven, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Eindhoven</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 0943 3265</institution-id><institution-id institution-id-type="GRID">grid.12295.3d</institution-id><institution>Department of Medical Psychology,</institution><institution>Tilburg University,</institution></institution-wrap>Tilburg, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Tilburg</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff8"><institution-wrap><institution-id institution-id-type="GRID">grid.430814.a</institution-id><institution>Division of Psychosocial Research & Epidemiology, Department of Psychosocial Research,</institution><institution>The Netherlands Cancer Institute,</institution></institution-wrap>Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Verdonck De Leeuw, Irma M" sort="Verdonck De Leeuw, Irma M" uniqKey="Verdonck De Leeuw I" first="Irma M." last="Verdonck-De Leeuw">Irma M. Verdonck-De Leeuw</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1754 9227</institution-id><institution-id institution-id-type="GRID">grid.12380.38</institution-id><institution>Department of Clinical Psychology, Amsterdam Public Health Institute,</institution><institution>Vrije Universiteit Amsterdam,</institution></institution-wrap>Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Amsterdam</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0435 165X</institution-id><institution-id institution-id-type="GRID">grid.16872.3a</institution-id><institution>EMGO+ Institute for Health and Care Research,</institution><institution>Vrije Universiteit and VU University Medical Centre,</institution></institution-wrap>Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Amsterdam</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0435 165X</institution-id><institution-id institution-id-type="GRID">grid.16872.3a</institution-id><institution>Cancer Centre Amsterdam (CCA),</institution><institution>VU University Medical Centre,</institution></institution-wrap>Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Amsterdam</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff5"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0435 165X</institution-id><institution-id institution-id-type="GRID">grid.16872.3a</institution-id><institution>Department of Otolaryngology–Head and Neck Surgery,</institution><institution>VU University Medical Centre,</institution></institution-wrap>Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Amsterdam</wicri:regionArea></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Cancer survivors have to deal with a wide range of physical symptoms, psychological, social and existential concerns, and lifestyle issues related to cancer and its treatment. Therefore, it is essential that they have access to optimal supportive care services. The eHealth self-management application Oncokompas was developed to support cancer survivors with where they need to turn to for advice and guidance, as well as to increase their knowledge on the availability of optimal support. A randomised controlled trial will be conducted to assess the efficacy, cost-utility and reach of Oncokompas as an eHealth self-management application compared with care as usual among cancer survivors.</p></sec><sec><title>Methods/design</title><p>Adult cancer survivors diagnosed with breast, colorectal or head and neck cancer or lymphoma who are at 3 months to 5 years since curative treatment will be included. In total, 544 cancer survivors will be randomly assigned to the intervention group or a wait-list control group. The primary outcome measure is patient activation. Secondary outcome measures include self-efficacy, personal control, perceived patient-physician interaction, need for supportive care, mental adjustment to cancer and health-related quality of life. Furthermore, cost-utility outcomes will be assessed. <italic>Reach</italic> is defined as the percentage of cancer survivors who get access to Oncokompas within the context of this trial. Questionnaires will be administered at baseline, post-intervention and at 3- and 6-month follow-up.</p></sec><sec><title>Discussion</title><p>In this study, we will evaluate the efficacy and cost-utility of Oncokompas among cancer survivors, as well as the reach of Oncokompas. These are essential first steps in the translation of research into practice and contribute to sustainable adoption, implementation and maintenance of an evidence-based Oncokompas.</p></sec><sec><title>Trial registration</title><p>Netherlands Trial Register identifier: <ext-link ext-link-type="uri" xlink:href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5774">NTR5774</ext-link>. Registered on 8 March 2016.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/s13063-017-1952-1) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Aaronson, Nk" uniqKey="Aaronson N">NK Aaronson</name></author><author><name sortKey="Mattioli, V" uniqKey="Mattioli V">V Mattioli</name></author><author><name sortKey="Minton, O" uniqKey="Minton O">O Minton</name></author><author><name sortKey="Weis, J" uniqKey="Weis J">J Weis</name></author><author><name sortKey="Johansen, C" uniqKey="Johansen C">C Johansen</name></author><author><name sortKey="Dalton, So" uniqKey="Dalton S">SO Dalton</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Fitch, Mi" uniqKey="Fitch M">MI Fitch</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Speck, Rm" 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Anja" sort="Van Der Hout, Anja" uniqKey="Van Der Hout A" first="Anja" last="Van Der Hout">Anja Van Der Hout</name></noRegion><name sortKey="Coupe, Veerle M H" sort="Coupe, Veerle M H" uniqKey="Coupe V" first="Veerle M. H." last="Coupé">Veerle M. H. Coupé</name><name sortKey="Cuijpers, Pim" sort="Cuijpers, Pim" uniqKey="Cuijpers P" first="Pim" last="Cuijpers">Pim Cuijpers</name><name sortKey="Cuijpers, Pim" sort="Cuijpers, Pim" uniqKey="Cuijpers P" first="Pim" last="Cuijpers">Pim Cuijpers</name><name sortKey="Jansen, Femke" sort="Jansen, Femke" uniqKey="Jansen F" first="Femke" last="Jansen">Femke Jansen</name><name sortKey="Jansen, Femke" sort="Jansen, Femke" uniqKey="Jansen F" first="Femke" last="Jansen">Femke Jansen</name><name sortKey="Leemans, C Rene" sort="Leemans, C Rene" uniqKey="Leemans C" first="C. René" last="Leemans">C. René Leemans</name><name sortKey="Leemans, C Rene" sort="Leemans, C Rene" uniqKey="Leemans C" first="C. René" last="Leemans">C. René Leemans</name><name sortKey="Van De Poll Franse, Lonneke V" sort="Van De Poll Franse, Lonneke V" uniqKey="Van De Poll Franse L" first="Lonneke V." last="Van De Poll-Franse">Lonneke V. Van De Poll-Franse</name><name sortKey="Van De Poll Franse, Lonneke V" sort="Van De Poll Franse, Lonneke V" uniqKey="Van De Poll Franse L" first="Lonneke V." last="Van De Poll-Franse">Lonneke V. Van De Poll-Franse</name><name sortKey="Van De Poll Franse, Lonneke V" sort="Van De Poll Franse, Lonneke V" uniqKey="Van De Poll Franse L" first="Lonneke V." last="Van De Poll-Franse">Lonneke V. Van De Poll-Franse</name><name sortKey="Van Der Hout, Anja" sort="Van Der Hout, Anja" uniqKey="Van Der Hout A" first="Anja" last="Van Der Hout">Anja Van Der Hout</name><name sortKey="Van Der Hout, Anja" sort="Van Der Hout, Anja" uniqKey="Van Der Hout A" first="Anja" last="Van Der Hout">Anja Van Der Hout</name><name sortKey="Van Uden Kraan, Cornelia F" sort="Van Uden Kraan, Cornelia F" uniqKey="Van Uden Kraan C" first="Cornelia F." last="Van Uden-Kraan">Cornelia F. Van Uden-Kraan</name><name sortKey="Van Uden Kraan, Cornelia F" sort="Van Uden Kraan, Cornelia F" uniqKey="Van Uden Kraan C" first="Cornelia F." last="Van Uden-Kraan">Cornelia F. Van Uden-Kraan</name><name sortKey="Van Uden Kraan, Cornelia F" sort="Van Uden Kraan, Cornelia F" uniqKey="Van Uden Kraan C" first="Cornelia F." last="Van Uden-Kraan">Cornelia F. Van Uden-Kraan</name><name sortKey="Verdonck De Leeuw, Irma M" sort="Verdonck De Leeuw, Irma M" uniqKey="Verdonck De Leeuw I" first="Irma M." last="Verdonck-De Leeuw">Irma M. Verdonck-De Leeuw</name><name sortKey="Verdonck De Leeuw, Irma M" sort="Verdonck De Leeuw, Irma M" uniqKey="Verdonck De Leeuw I" first="Irma M." last="Verdonck-De Leeuw">Irma M. Verdonck-De Leeuw</name><name sortKey="Verdonck De Leeuw, Irma M" sort="Verdonck De Leeuw, Irma M" uniqKey="Verdonck De Leeuw I" first="Irma M." last="Verdonck-De Leeuw">Irma M. Verdonck-De Leeuw</name><name sortKey="Verdonck De Leeuw, Irma M" sort="Verdonck De Leeuw, Irma M" uniqKey="Verdonck De Leeuw I" first="Irma M." last="Verdonck-De Leeuw">Irma M. Verdonck-De Leeuw</name><name sortKey="Witte, Birgit I" sort="Witte, Birgit I" uniqKey="Witte B" first="Birgit I." last="Witte">Birgit I. Witte</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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