Effectiveness and cost-utility of a guided self-help exercise program for patients treated with total laryngectomy: protocol of a multi-center randomized controlled trial
Identifieur interne : 000C33 ( Pmc/Curation ); précédent : 000C32; suivant : 000C34Effectiveness and cost-utility of a guided self-help exercise program for patients treated with total laryngectomy: protocol of a multi-center randomized controlled trial
Auteurs : Femke Jansen [Pays-Bas] ; Ingrid C. Cnossen [Pays-Bas] ; Simone E. J. Eerenstein [Pays-Bas] ; Veerle M. H. Coupé [Pays-Bas] ; Birgit I. Witte [Pays-Bas] ; Cornelia F. Van Uden-Kraan [Pays-Bas] ; Patricia Doornaert [Pays-Bas] ; Weibel W. Braunius [Pays-Bas] ; Remco De Bree [Pays-Bas] ; José A. U. Hardillo [Pays-Bas] ; Jimmie Honings [Pays-Bas] ; György B. Halmos [Pays-Bas] ; C. René Leemans [Pays-Bas] ; Irma M. Verdonck-De Leeuw [Pays-Bas]Source :
- BMC Cancer [ 1471-2407 ] ; 2016.
Abstract
Total laryngectomy with or without adjuvant (chemo)radiation often induces speech, swallowing and neck and shoulder problems. Speech, swallowing and shoulder exercises may prevent or diminish these problems. The aim of the present paper is to describe the study, which is designed to investigate the effectiveness and cost-utility of a guided self-help exercise program built into the application “In Tune without Cords” among patients treated with total laryngectomy.
Patients, up to 5 years earlier treated with total laryngectomy with or without (chemo)radiation will be recruited for participation in this study. Patients willing to participate will be randomized to the intervention or control group (1:1). Patients in the intervention group will be provided access to a guided self-help exercise program and a self-care education program built into the application “In Tune without Cords”. Patients in the control group will only be provided access to the self-care education program. The primary outcome is the difference in swallowing quality (SWAL-QOL) between the intervention and control group. Secondary outcome measures address speech problems (SHI), shoulder disability (SDQ), quality of life (EORTC QLQ-C30, QLQ-H&N35 and EQ-5D), direct and indirect costs (adjusted iMCQ and iPCQ measures) and self-management (PAM). Patients will be asked to complete these outcome measures at baseline, immediately after the intervention or control period (i.e. at 3 months follow-up) and at 6 months follow-up.
This randomized controlled trial will provide knowledge on the effectiveness of a guided self-help exercise program for patients treated with total laryngectomy. In addition, information on the value for money of such an exercise program will be provided. If this guided self-help program is (cost)effective for patients treated with total laryngectomy, the next step will be to implement this exercise program in current clinical practice.
Url:
DOI: 10.1186/s12885-016-2613-6
PubMed: 27484126
PubMed Central: 4971642
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Cnossen</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Eerenstein, Simone E J" sort="Eerenstein, Simone E J" uniqKey="Eerenstein S" first="Simone E. J." last="Eerenstein">Simone E. J. Eerenstein</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam</wicri:regionArea></affiliation></author><author><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><affiliation wicri:level="1"><nlm:aff id="Aff2">Department of Epidemiology and Biostatistics, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Epidemiology and Biostatistics, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Witte, Birgit I" sort="Witte, Birgit I" uniqKey="Witte B" first="Birgit I." last="Witte">Birgit I. Witte</name><affiliation wicri:level="1"><nlm:aff id="Aff2">Department of Epidemiology and Biostatistics, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Epidemiology and Biostatistics, VU University Medical Center, PO Box 7057, 1007 MB 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. Van Uden-Kraan</name><affiliation wicri:level="1"><nlm:aff id="Aff3">Department of Clinical Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Clinical Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Doornaert, Patricia" sort="Doornaert, Patricia" uniqKey="Doornaert P" first="Patricia" last="Doornaert">Patricia Doornaert</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Department of Radiation Oncology, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Radiation Oncology, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Braunius, Weibel W" sort="Braunius, Weibel W" uniqKey="Braunius W" first="Weibel W." last="Braunius">Weibel W. Braunius</name><affiliation wicri:level="1"><nlm:aff id="Aff5">Department of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, Heidelberglaan 100, 3584 CX Utrecht</wicri:regionArea></affiliation></author><author><name sortKey="De Bree, Remco" sort="De Bree, Remco" uniqKey="De Bree R" first="Remco" last="De Bree">Remco De Bree</name><affiliation wicri:level="1"><nlm:aff id="Aff5">Department of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, Heidelberglaan 100, 3584 CX Utrecht</wicri:regionArea></affiliation></author><author><name sortKey="Hardillo, Jose A U" sort="Hardillo, Jose A U" uniqKey="Hardillo J" first="José A. U." last="Hardillo">José A. U. Hardillo</name><affiliation wicri:level="1"><nlm:aff id="Aff6">Department of Otorhinolaryngology, Erasmus MC, University Medical Center, PO Box 2040, 3000 CA Rotterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Otorhinolaryngology, Erasmus MC, University Medical Center, PO Box 2040, 3000 CA Rotterdam</wicri:regionArea></affiliation></author><author><name sortKey="Honings, Jimmie" sort="Honings, Jimmie" uniqKey="Honings J" first="Jimmie" last="Honings">Jimmie Honings</name><affiliation wicri:level="1"><nlm:aff id="Aff7">Department of Otorhinolaryngology-Head and Neck Surgery, Radboud University Nijmegen Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Otorhinolaryngology-Head and Neck Surgery, Radboud University Nijmegen Medical Center, PO Box 9101, 6500 HB Nijmegen</wicri:regionArea></affiliation></author><author><name sortKey="Halmos, Gyorgy B" sort="Halmos, Gyorgy B" uniqKey="Halmos G" first="György B." last="Halmos">György B. Halmos</name><affiliation wicri:level="1"><nlm:aff id="Aff8">Department of Otorhinolaryngology, Head and Neck Surgery, University of Groningen, University Medical Center Groningen, PO Box 30.001, 9700 RB Groningen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Otorhinolaryngology, Head and Neck Surgery, University of Groningen, University Medical Center Groningen, PO Box 30.001, 9700 RB Groningen</wicri:regionArea></affiliation></author><author><name sortKey="Leemans, C Rene" sort="Leemans, C Rene" uniqKey="Leemans C" first="C. René" last="Leemans">C. René Leemans</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB 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">Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff3">Department of Clinical Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Clinical Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">27484126</idno><idno type="pmc">4971642</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4971642</idno><idno type="RBID">PMC:4971642</idno><idno type="doi">10.1186/s12885-016-2613-6</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">000C34</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000C34</idno><idno type="wicri:Area/Pmc/Curation">000C33</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000C33</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Effectiveness and cost-utility of a guided self-help exercise program for patients treated with total laryngectomy: protocol of a multi-center randomized controlled trial</title><author><name sortKey="Jansen, Femke" sort="Jansen, Femke" uniqKey="Jansen F" first="Femke" last="Jansen">Femke Jansen</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Cnossen, Ingrid C" sort="Cnossen, Ingrid C" uniqKey="Cnossen I" first="Ingrid C." last="Cnossen">Ingrid C. Cnossen</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Eerenstein, Simone E J" sort="Eerenstein, Simone E J" uniqKey="Eerenstein S" first="Simone E. J." last="Eerenstein">Simone E. J. Eerenstein</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam</wicri:regionArea></affiliation></author><author><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><affiliation wicri:level="1"><nlm:aff id="Aff2">Department of Epidemiology and Biostatistics, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Epidemiology and Biostatistics, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Witte, Birgit I" sort="Witte, Birgit I" uniqKey="Witte B" first="Birgit I." last="Witte">Birgit I. Witte</name><affiliation wicri:level="1"><nlm:aff id="Aff2">Department of Epidemiology and Biostatistics, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Epidemiology and Biostatistics, VU University Medical Center, PO Box 7057, 1007 MB 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. Van Uden-Kraan</name><affiliation wicri:level="1"><nlm:aff id="Aff3">Department of Clinical Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Clinical Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Doornaert, Patricia" sort="Doornaert, Patricia" uniqKey="Doornaert P" first="Patricia" last="Doornaert">Patricia Doornaert</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Department of Radiation Oncology, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Radiation Oncology, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Braunius, Weibel W" sort="Braunius, Weibel W" uniqKey="Braunius W" first="Weibel W." last="Braunius">Weibel W. Braunius</name><affiliation wicri:level="1"><nlm:aff id="Aff5">Department of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, Heidelberglaan 100, 3584 CX Utrecht</wicri:regionArea></affiliation></author><author><name sortKey="De Bree, Remco" sort="De Bree, Remco" uniqKey="De Bree R" first="Remco" last="De Bree">Remco De Bree</name><affiliation wicri:level="1"><nlm:aff id="Aff5">Department of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, Heidelberglaan 100, 3584 CX Utrecht</wicri:regionArea></affiliation></author><author><name sortKey="Hardillo, Jose A U" sort="Hardillo, Jose A U" uniqKey="Hardillo J" first="José A. U." last="Hardillo">José A. U. Hardillo</name><affiliation wicri:level="1"><nlm:aff id="Aff6">Department of Otorhinolaryngology, Erasmus MC, University Medical Center, PO Box 2040, 3000 CA Rotterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Otorhinolaryngology, Erasmus MC, University Medical Center, PO Box 2040, 3000 CA Rotterdam</wicri:regionArea></affiliation></author><author><name sortKey="Honings, Jimmie" sort="Honings, Jimmie" uniqKey="Honings J" first="Jimmie" last="Honings">Jimmie Honings</name><affiliation wicri:level="1"><nlm:aff id="Aff7">Department of Otorhinolaryngology-Head and Neck Surgery, Radboud University Nijmegen Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Otorhinolaryngology-Head and Neck Surgery, Radboud University Nijmegen Medical Center, PO Box 9101, 6500 HB Nijmegen</wicri:regionArea></affiliation></author><author><name sortKey="Halmos, Gyorgy B" sort="Halmos, Gyorgy B" uniqKey="Halmos G" first="György B." last="Halmos">György B. Halmos</name><affiliation wicri:level="1"><nlm:aff id="Aff8">Department of Otorhinolaryngology, Head and Neck Surgery, University of Groningen, University Medical Center Groningen, PO Box 30.001, 9700 RB Groningen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Otorhinolaryngology, Head and Neck Surgery, University of Groningen, University Medical Center Groningen, PO Box 30.001, 9700 RB Groningen</wicri:regionArea></affiliation></author><author><name sortKey="Leemans, C Rene" sort="Leemans, C Rene" uniqKey="Leemans C" first="C. René" last="Leemans">C. René Leemans</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB 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">Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff3">Department of Clinical Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Clinical Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam</wicri:regionArea></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>Total laryngectomy with or without adjuvant (chemo)radiation often induces speech, swallowing and neck and shoulder problems. Speech, swallowing and shoulder exercises may prevent or diminish these problems. The aim of the present paper is to describe the study, which is designed to investigate the effectiveness and cost-utility of a guided self-help exercise program built into the application “In Tune without Cords” among patients treated with total laryngectomy.</p></sec><sec><title>Methods/design</title><p>Patients, up to 5 years earlier treated with total laryngectomy with or without (chemo)radiation will be recruited for participation in this study. Patients willing to participate will be randomized to the intervention or control group (1:1). Patients in the intervention group will be provided access to a guided self-help exercise program and a self-care education program built into the application “In Tune without Cords”. Patients in the control group will only be provided access to the self-care education program. The primary outcome is the difference in swallowing quality (SWAL-QOL) between the intervention and control group. Secondary outcome measures address speech problems (SHI), shoulder disability (SDQ), quality of life (EORTC QLQ-C30, QLQ-H&N35 and EQ-5D), direct and indirect costs (adjusted iMCQ and iPCQ measures) and self-management (PAM). Patients will be asked to complete these outcome measures at baseline, immediately after the intervention or control period (i.e. at 3 months follow-up) and at 6 months follow-up.</p></sec><sec><title>Discussion</title><p>This randomized controlled trial will provide knowledge on the effectiveness of a guided self-help exercise program for patients treated with total laryngectomy. In addition, information on the value for money of such an exercise program will be provided. If this guided self-help program is (cost)effective for patients treated with total laryngectomy, the next step will be to implement this exercise program in current clinical practice.</p></sec><sec><title>Trial registration</title><p><ext-link ext-link-type="uri" xlink:href="http://www.trialregister.nl">NTR5255</ext-link> Protocol version 4 date September 2015.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Timmermans, Aj" uniqKey="Timmermans A">AJ Timmermans</name></author><author><name sortKey="Krap, M" uniqKey="Krap M">M Krap</name></author><author><name sortKey="Hilgers, Fjm" uniqKey="Hilgers F">FJM Hilgers</name></author><author><name sortKey="Van Den Brekel, Mwm" uniqKey="Van Den Brekel M">MWM van den Brekel</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Szuecs, M" uniqKey="Szuecs M">M Szuecs</name></author><author><name sortKey="Kuhnt, T" uniqKey="Kuhnt 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H.</given-names></name><address><email>v.coupe@vumc.nl</email></address><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Witte</surname><given-names>Birgit I.</given-names></name><address><email>b.witte@vumc.nl</email></address><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>van Uden-Kraan</surname><given-names>Cornelia F.</given-names></name><address><email>c.vanuden@vumc.nl</email></address><xref ref-type="aff" rid="Aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Doornaert</surname><given-names>Patricia</given-names></name><address><email>p.doornaert@vumc.nl</email></address><xref ref-type="aff" rid="Aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Braunius</surname><given-names>Weibel W.</given-names></name><address><email>w.braunius@umcutrecht.nl</email></address><xref ref-type="aff" rid="Aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>De Bree</surname><given-names>Remco</given-names></name><address><email>r.debree@umcutrecht.nl</email></address><xref ref-type="aff" rid="Aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Hardillo</surname><given-names>José A. U.</given-names></name><address><email>j.hardillo@erasmusmc.nl</email></address><xref ref-type="aff" rid="Aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Honings</surname><given-names>Jimmie</given-names></name><address><email>Jimmie.honings@radboudumc.nl</email></address><xref ref-type="aff" rid="Aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Halmos</surname><given-names>György B.</given-names></name><address><email>g.b.halmos@umcg.nl</email></address><xref ref-type="aff" rid="Aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Leemans</surname><given-names>C. René</given-names></name><address><email>cr.leemans@vumc.nl</email></address><xref ref-type="aff" rid="Aff1">1</xref></contrib><contrib contrib-type="author" corresp="yes"><name><surname>Verdonck-de Leeuw</surname><given-names>Irma M.</given-names></name><address><phone>+31 20 444 0931</phone><email>im.verdonck@vumc.nl</email></address><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff3">3</xref></contrib><aff id="Aff1"><label>1</label>Department of Otolaryngology-Head and Neck Surgery, Cancer Center Amsterdam (CCA), VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</aff><aff id="Aff2"><label>2</label>Department of Epidemiology and Biostatistics, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</aff><aff id="Aff3"><label>3</label>Department of Clinical Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam, The Netherlands</aff><aff id="Aff4"><label>4</label>Department of Radiation Oncology, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands</aff><aff id="Aff5"><label>5</label>Department of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands</aff><aff id="Aff6"><label>6</label>Department of Otorhinolaryngology, Erasmus MC, University Medical Center, PO Box 2040, 3000 CA Rotterdam, The Netherlands</aff><aff id="Aff7"><label>7</label>Department of Otorhinolaryngology-Head and Neck Surgery, Radboud University Nijmegen Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands</aff><aff id="Aff8"><label>8</label>Department of Otorhinolaryngology, Head and Neck Surgery, University of Groningen, University Medical Center Groningen, PO Box 30.001, 9700 RB Groningen, The Netherlands</aff></contrib-group><pub-date pub-type="epub"><day>2</day><month>8</month><year>2016</year></pub-date><pub-date pub-type="pmc-release"><day>2</day><month>8</month><year>2016</year></pub-date><pub-date pub-type="collection"><year>2016</year></pub-date><volume>16</volume><elocation-id>580</elocation-id><history><date date-type="received"><day>27</day><month>10</month><year>2015</year></date><date date-type="accepted"><day>25</day><month>7</month><year>2016</year></date></history><permissions><copyright-statement>© The Author(s). 2016</copyright-statement><license license-type="OpenAccess"><license-p><bold>Open Access</bold>This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated.</license-p></license></permissions><abstract id="Abs1"><sec><title>Background</title><p>Total laryngectomy with or without adjuvant (chemo)radiation often induces speech, swallowing and neck and shoulder problems. Speech, swallowing and shoulder exercises may prevent or diminish these problems. The aim of the present paper is to describe the study, which is designed to investigate the effectiveness and cost-utility of a guided self-help exercise program built into the application “In Tune without Cords” among patients treated with total laryngectomy.</p></sec><sec><title>Methods/design</title><p>Patients, up to 5 years earlier treated with total laryngectomy with or without (chemo)radiation will be recruited for participation in this study. Patients willing to participate will be randomized to the intervention or control group (1:1). Patients in the intervention group will be provided access to a guided self-help exercise program and a self-care education program built into the application “In Tune without Cords”. Patients in the control group will only be provided access to the self-care education program. The primary outcome is the difference in swallowing quality (SWAL-QOL) between the intervention and control group. Secondary outcome measures address speech problems (SHI), shoulder disability (SDQ), quality of life (EORTC QLQ-C30, QLQ-H&N35 and EQ-5D), direct and indirect costs (adjusted iMCQ and iPCQ measures) and self-management (PAM). Patients will be asked to complete these outcome measures at baseline, immediately after the intervention or control period (i.e. at 3 months follow-up) and at 6 months follow-up.</p></sec><sec><title>Discussion</title><p>This randomized controlled trial will provide knowledge on the effectiveness of a guided self-help exercise program for patients treated with total laryngectomy. In addition, information on the value for money of such an exercise program will be provided. If this guided self-help program is (cost)effective for patients treated with total laryngectomy, the next step will be to implement this exercise program in current clinical practice.</p></sec><sec><title>Trial registration</title><p><ext-link ext-link-type="uri" xlink:href="http://www.trialregister.nl">NTR5255</ext-link> Protocol version 4 date September 2015.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Exercise program</kwd><kwd>Total laryngectomy</kwd><kwd>Head and neck cancer</kwd><kwd>Swallowing problems</kwd><kwd>Speech problems</kwd><kwd>Shoulder problems</kwd></kwd-group><funding-group><award-group><funding-source><institution>Michel Keijzer Fund</institution></funding-source></award-group></funding-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2016</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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