A parallel-group randomized clinical trial of individually tailored, multidisciplinary, palliative rehabilitation for patients with newly diagnosed advanced cancer: the Pal-Rehab study protocol
Identifieur interne : 000C47 ( Pmc/Curation ); précédent : 000C46; suivant : 000C48A parallel-group randomized clinical trial of individually tailored, multidisciplinary, palliative rehabilitation for patients with newly diagnosed advanced cancer: the Pal-Rehab study protocol
Auteurs : Lise Nottelmann [Danemark] ; Mogens Groenvold [Danemark] ; Tove Bahn Vejlgaard [Danemark] ; Morten Aagaard Petersen [Danemark] ; Lars Henrik Jensen [Danemark]Source :
- BMC Cancer [ 1471-2407 ] ; 2017.
Abstract
The effect of early palliative care and rehabilitation on the quality of life of patients with advanced cancer has been only sparsely described and needs further investigation. In the present trial we combine elements of early, specialized palliative care with cancer rehabilitation in a 12-week individually tailored, palliative rehabilitation program initiated shortly after a diagnosis of advanced cancer.
This single center, randomized, controlled trial will include 300 patients with newly diagnosed advanced cancer recruited from the Department of Oncology, Vejle Hospital. The patients are randomized to a specialized palliative rehabilitation intervention integrated in standard oncology care or to standard oncology care alone. The intervention consists of a multidisciplinary group program, individual consultations, or a combination of both. At baseline and after six and 12 weeks the patients will be asked to fill out questionnaires on symptoms, quality of life, and symptoms of depression and anxiety. Among the symptoms and problems assessed, patients are asked to indicate the problem they need help with to the largest extent. The effect of the intervention on this problem is the primary outcome measure of the study. Secondary outcome measures include survival and economic consequences.
To our knowledge the Pal-Rehab study is the first randomized, controlled, phase III trial to evaluate individually tailored, palliative rehabilitation in standard oncology care initiated shortly after an advanced cancer diagnosis. The study will contribute with evidence on the effectiveness of implementing early palliative care in standard oncology treatment and hopefully offer new knowledge and future directions as to the content of palliative rehabilitation programs.
Clinicaltrials.gov Identifier:
Url:
DOI: 10.1186/s12885-017-3558-0
PubMed: 28835218
PubMed Central: 5569500
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sort="Jensen, Lars Henrik" uniqKey="Jensen L" first="Lars Henrik" last="Jensen">Lars Henrik Jensen</name><affiliation wicri:level="1"><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0512 5814</institution-id><institution-id institution-id-type="GRID">grid.417271.6</institution-id><institution></institution><institution>Danish Colorectal Cancer Center South, Vejle Hospital,</institution></institution-wrap>Beriderbakken 4, Vejle, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>Beriderbakken 4, Vejle</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff5"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 0728 0170</institution-id><institution-id institution-id-type="GRID">grid.10825.3e</institution-id><institution>Institute of Regional Health Research,</institution><institution>University of Southern Denmark,</institution></institution-wrap>Odense, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>Odense</wicri:regionArea></affiliation></author></analytic><series><title level="j">BMC Cancer</title><idno type="eISSN">1471-2407</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 id="Par1">The effect of early palliative care and rehabilitation on the quality of life of patients with advanced cancer has been only sparsely described and needs further investigation. In the present trial we combine elements of early, specialized palliative care with cancer rehabilitation in a 12-week individually tailored, palliative rehabilitation program initiated shortly after a diagnosis of advanced cancer.</p></sec><sec><title>Methods</title><p id="Par2">This single center, randomized, controlled trial will include 300 patients with newly diagnosed advanced cancer recruited from the Department of Oncology, Vejle Hospital. The patients are randomized to a specialized palliative rehabilitation intervention integrated in standard oncology care or to standard oncology care alone. The intervention consists of a multidisciplinary group program, individual consultations, or a combination of both. At baseline and after six and 12 weeks the patients will be asked to fill out questionnaires on symptoms, quality of life, and symptoms of depression and anxiety. Among the symptoms and problems assessed, patients are asked to indicate the problem they need help with to the largest extent. The effect of the intervention on this problem is the primary outcome measure of the study. Secondary outcome measures include survival and economic consequences.</p></sec><sec><title>Discussion</title><p id="Par3">To our knowledge the Pal-Rehab study is the first randomized, controlled, phase III trial to evaluate individually tailored, palliative rehabilitation in standard oncology care initiated shortly after an advanced cancer diagnosis. The study will contribute with evidence on the effectiveness of implementing early palliative care in standard oncology treatment and hopefully offer new knowledge and future directions as to the content of palliative rehabilitation programs.</p></sec><sec><title>Trial Registration</title><p id="Par4">Clinicaltrials.gov Identifier: <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02332317?id=NCT02332317&rank=1">NCT02332317</ext-link>, registered retrospectively on December 30, 2014. One study participant had been enrolled at the time.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Johnsen, At" uniqKey="Johnsen A">AT Johnsen</name></author><author><name sortKey="Petersen, Ma" uniqKey="Petersen M">MA Petersen</name></author><author><name sortKey="Pedersen, L" uniqKey="Pedersen L">L Pedersen</name></author><author><name sortKey="Groenvold, M" uniqKey="Groenvold M">M Groenvold</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Horlait, M" uniqKey="Horlait M">M Horlait</name></author><author><name sortKey="Chambaere, K" uniqKey="Chambaere K">K Chambaere</name></author><author><name sortKey="Pardon, K" uniqKey="Pardon K">K Pardon</name></author><author><name sortKey="Deliens, L" uniqKey="Deliens L">L Deliens</name></author><author><name sortKey="Van Belle, S" uniqKey="Van Belle S">S Van 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<front><journal-meta><journal-id journal-id-type="nlm-ta">BMC Cancer</journal-id><journal-id journal-id-type="iso-abbrev">BMC Cancer</journal-id><journal-title-group><journal-title>BMC Cancer</journal-title></journal-title-group><issn pub-type="epub">1471-2407</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">28835218</article-id><article-id pub-id-type="pmc">5569500</article-id><article-id pub-id-type="publisher-id">3558</article-id><article-id pub-id-type="doi">10.1186/s12885-017-3558-0</article-id><article-categories><subj-group subj-group-type="heading"><subject>Study Protocol</subject></subj-group></article-categories><title-group><article-title>A parallel-group randomized clinical trial of individually tailored, multidisciplinary, palliative rehabilitation for patients with newly diagnosed advanced cancer: the Pal-Rehab study protocol</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">http://orcid.org/0000-0002-2900-3091</contrib-id><name><surname>Nottelmann</surname><given-names>Lise</given-names></name><address><email>Lise.nottelmann@rsyd.dk</email></address><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Groenvold</surname><given-names>Mogens</given-names></name><address><email>mold@sund.ku.dk</email></address><xref ref-type="aff" rid="Aff2">2</xref><xref ref-type="aff" rid="Aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Vejlgaard</surname><given-names>Tove Bahn</given-names></name><address><email>Tove.vejlgaard@gmail.com</email></address><xref ref-type="aff" rid="Aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Petersen</surname><given-names>Morten Aagaard</given-names></name><address><email>Morten.Aagaard.Petersen@regionh.dk</email></address><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Jensen</surname><given-names>Lars Henrik</given-names></name><address><email>lars.henrik.jensen@rsyd.dk</email></address><xref ref-type="aff" rid="Aff4">4</xref><xref ref-type="aff" rid="Aff5">5</xref></contrib><aff id="Aff1"><label>1</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0512 5814</institution-id><institution-id institution-id-type="GRID">grid.417271.6</institution-id><institution></institution><institution>Department of Oncology, Palliative Team, Vejle Hospital,</institution></institution-wrap>Beriderbakken 4, 7100 Vejle, Denmark</aff><aff id="Aff2"><label>2</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0646 7373</institution-id><institution-id institution-id-type="GRID">grid.4973.9</institution-id><institution>Research Unit, Department of Palliative Medicine, Bispebjerg Hospital,</institution><institution>Copenhagen University Hospital,</institution></institution-wrap>Copenhagen, Denmark</aff><aff id="Aff3"><label>3</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 0674 042X</institution-id><institution-id institution-id-type="GRID">grid.5254.6</institution-id><institution>Department of Public Health,</institution><institution>University of Copenhagen,</institution></institution-wrap>Copenhagen, Denmark</aff><aff id="Aff4"><label>4</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0512 5814</institution-id><institution-id institution-id-type="GRID">grid.417271.6</institution-id><institution></institution><institution>Danish Colorectal Cancer Center South, Vejle Hospital,</institution></institution-wrap>Beriderbakken 4, Vejle, Denmark</aff><aff id="Aff5"><label>5</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 0728 0170</institution-id><institution-id institution-id-type="GRID">grid.10825.3e</institution-id><institution>Institute of Regional Health Research,</institution><institution>University of Southern Denmark,</institution></institution-wrap>Odense, Denmark</aff></contrib-group><pub-date pub-type="epub"><day>23</day><month>8</month><year>2017</year></pub-date><pub-date pub-type="pmc-release"><day>23</day><month>8</month><year>2017</year></pub-date><pub-date pub-type="collection"><year>2017</year></pub-date><volume>17</volume><elocation-id>560</elocation-id><history><date date-type="received"><day>30</day><month>1</month><year>2017</year></date><date date-type="accepted"><day>16</day><month>8</month><year>2017</year></date></history><permissions><copyright-statement>© The Author(s). 2017</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 id="Par1">The effect of early palliative care and rehabilitation on the quality of life of patients with advanced cancer has been only sparsely described and needs further investigation. In the present trial we combine elements of early, specialized palliative care with cancer rehabilitation in a 12-week individually tailored, palliative rehabilitation program initiated shortly after a diagnosis of advanced cancer.</p></sec><sec><title>Methods</title><p id="Par2">This single center, randomized, controlled trial will include 300 patients with newly diagnosed advanced cancer recruited from the Department of Oncology, Vejle Hospital. The patients are randomized to a specialized palliative rehabilitation intervention integrated in standard oncology care or to standard oncology care alone. The intervention consists of a multidisciplinary group program, individual consultations, or a combination of both. At baseline and after six and 12 weeks the patients will be asked to fill out questionnaires on symptoms, quality of life, and symptoms of depression and anxiety. Among the symptoms and problems assessed, patients are asked to indicate the problem they need help with to the largest extent. The effect of the intervention on this problem is the primary outcome measure of the study. Secondary outcome measures include survival and economic consequences.</p></sec><sec><title>Discussion</title><p id="Par3">To our knowledge the Pal-Rehab study is the first randomized, controlled, phase III trial to evaluate individually tailored, palliative rehabilitation in standard oncology care initiated shortly after an advanced cancer diagnosis. The study will contribute with evidence on the effectiveness of implementing early palliative care in standard oncology treatment and hopefully offer new knowledge and future directions as to the content of palliative rehabilitation programs.</p></sec><sec><title>Trial Registration</title><p id="Par4">Clinicaltrials.gov Identifier: <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02332317?id=NCT02332317&rank=1">NCT02332317</ext-link>, registered retrospectively on December 30, 2014. One study participant had been enrolled at the time.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Palliative care</kwd><kwd>Early integrated care</kwd><kwd>Rehabilitation</kwd><kwd>Supportive care</kwd><kwd>Advanced cancer</kwd><kwd>Quality of life research</kwd><kwd>Patient involvement</kwd><kwd>Randomized clinical trial</kwd><kwd>Cost-effectiveness</kwd><kwd>Study protocol</kwd></kwd-group><funding-group><award-group><funding-source><institution-wrap><institution-id institution-id-type="FundRef">http://dx.doi.org/10.13039/100008363</institution-id><institution>Kræftens Bekæmpelse</institution></institution-wrap></funding-source><award-id>R113-A6938-14-S34</award-id><principal-award-recipient><name><surname>Jensen</surname><given-names>Lars Henrik</given-names></name></principal-award-recipient></award-group><award-group><funding-source><institution>Research Counsil of Lillebaelt Hospital</institution></funding-source></award-group><award-group><funding-source><institution>The Andreas and Grethe Gullev Hansens’ Foundation</institution></funding-source></award-group><award-group><funding-source><institution>The Family Hede Nielsens’ Foundation</institution></funding-source></award-group></funding-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2017</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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