A complex nursing intervention of complementary and alternative medicine (CAM) to increase quality of life in patients with breast and gynecologic cancer undergoing chemotherapy: study protocol for a partially randomized patient preference trial.
Identifieur interne : 001097 ( Main/Corpus ); précédent : 001096; suivant : 001098A complex nursing intervention of complementary and alternative medicine (CAM) to increase quality of life in patients with breast and gynecologic cancer undergoing chemotherapy: study protocol for a partially randomized patient preference trial.
Auteurs : Nadja Klafke ; Cornelia Mahler ; Cornelia Von Hagens ; Justine Rochon ; Andreas Schneeweiss ; Andreas Müller ; Hans-Joachim Salize ; Stefanie JoosSource :
- Trials [ 1745-6215 ] ; 2015.
English descriptors
- KwdEn :
- Breast Neoplasms (psychology), Breast Neoplasms (therapy), Complementary Therapies (nursing), Data Interpretation, Statistical (MeSH), Female (MeSH), Genital Neoplasms, Female (psychology), Genital Neoplasms, Female (therapy), Humans (MeSH), Outcome Assessment, Health Care (MeSH), Quality Assurance, Health Care (MeSH), Quality of Life (MeSH), Sample Size (MeSH), Social Support (MeSH).
- MESH :
- nursing : Complementary Therapies.
- psychology : Breast Neoplasms, Genital Neoplasms, Female.
- therapy : Breast Neoplasms, Genital Neoplasms, Female.
- Data Interpretation, Statistical, Female, Humans, Outcome Assessment, Health Care, Quality Assurance, Health Care, Quality of Life, Sample Size, Social Support.
Abstract
BACKGROUND
Health-related quality of life (HRQoL) is most adversely affected in cancer patients between diagnosis and the end of chemotherapy. The aim of the Complementary Nursing in Gynecologic Oncology (CONGO) study is to assess the effectiveness of a complex nursing care intervention of CAM to increase HRQoL in cancer patients undergoing chemotherapy.
METHODS/DESIGN
CONGO is a prospective partially randomized patient preference (PRPP) trial including adult women diagnosed with breast and gynecologic cancer starting a new chemotherapy regimen. Patients without strong preferences for CAM will be randomized to usual nursing care or complex nursing care; those patients with strong preferences will be allowed their choice. The intervention consists of three interacting and intertwined elements: CAM nursing intervention packet, counseling on CAM using a resource-oriented approach and evidence-based informational material on CAM. Primary outcome data on participants' HRQoL will be collected from baseline until the end of treatment and long-term follow-up using the EORTC-QLQ-C30. Secondary outcomes include nausea, fatigue, pain, anxiety/depression, social support, self-efficacy, patient competence, spiritual wellbeing, and satisfaction with care. Accompanying research on economic outcomes as well as a mixed-methods process evaluation will be conducted. A total of 590 patients (236 patients in the randomized part of the study and 354 patients in the observational part of the study) will be recruited in the two outpatient clinics. The first analysis step will be the intention-to-treat (ITT) analysis of the randomized part of the trial. A linear mixed model will be used to compare the continuous primary endpoint between the intervention and control arm of the randomized group. The observational part of the trial will be analyzed descriptively. External validity will be assessed by comparing randomized with nonrandomized patients.
DISCUSSION
Cancer patients are increasingly using CAM as supportive cancer care, however, a patient-centered model of care that includes CAM for the patient during chemotherapy still needs to be evaluated. This protocol has been designed to test if the effects of the intervention go beyond potential benefits in quality-of-life outcomes.
TRIAL REGISTRATION
German Clinical Trials Register (DRKS), DRKS00006056 (15 April 2014).
DOI: 10.1186/s13063-014-0538-4
PubMed: 25887713
PubMed Central: PMC4337273
Links to Exploration step
pubmed:25887713Le document en format XML
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cornelia.mahler@med.uni-heidelberg.de.</nlm:affiliation></affiliation></author><author><name sortKey="Von Hagens, Cornelia" sort="Von Hagens, Cornelia" uniqKey="Von Hagens C" first="Cornelia" last="Von Hagens">Cornelia Von Hagens</name><affiliation><nlm:affiliation>Department of Gynaecological Endocrinology and Reproductive Medicine, University Women's Hospital Heidelberg, Im Neuenheimer Feld 440, D-69120, Heidelberg, Germany. cornelia.von.hagens@med.uni-heidelberg.de.</nlm:affiliation></affiliation></author><author><name sortKey="Rochon, Justine" sort="Rochon, Justine" uniqKey="Rochon J" first="Justine" last="Rochon">Justine Rochon</name><affiliation><nlm:affiliation>Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, D-69120, Heidelberg, Germany. rochon@imbi.uni-heidelberg.de.</nlm:affiliation></affiliation></author><author><name sortKey="Schneeweiss, Andreas" sort="Schneeweiss, Andreas" uniqKey="Schneeweiss A" first="Andreas" last="Schneeweiss">Andreas Schneeweiss</name><affiliation><nlm:affiliation>National Center for Tumor Diseases, University Hospital, Im Neuenheimer Feld 460, D-69120, Heidelberg, Germany. andreas.schneeweiss@med.uni-heidelberg.de.</nlm:affiliation></affiliation></author><author><name sortKey="Muller, Andreas" sort="Muller, Andreas" uniqKey="Muller A" first="Andreas" last="Müller">Andreas Müller</name><affiliation><nlm:affiliation>Community Hospital Karlsruhe, Moltkestraße 90, D-76133, Karlsruhe, Germany. andreas.mueller.fk@klinikum-karlsruhe.de.</nlm:affiliation></affiliation></author><author><name sortKey="Salize, Hans Joachim" sort="Salize, Hans Joachim" uniqKey="Salize H" first="Hans-Joachim" last="Salize">Hans-Joachim Salize</name><affiliation><nlm:affiliation>Central Institute of Mental Health, Mental Health Services Research Group, Medical Faculty Mannheim/Heidelberg University, Mannheim, D-68159, Germany. 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Heidelberg, Voßstr. 2, D-69115, Heidelberg, Germany. cornelia.mahler@med.uni-heidelberg.de.</nlm:affiliation></affiliation></author><author><name sortKey="Von Hagens, Cornelia" sort="Von Hagens, Cornelia" uniqKey="Von Hagens C" first="Cornelia" last="Von Hagens">Cornelia Von Hagens</name><affiliation><nlm:affiliation>Department of Gynaecological Endocrinology and Reproductive Medicine, University Women's Hospital Heidelberg, Im Neuenheimer Feld 440, D-69120, Heidelberg, Germany. cornelia.von.hagens@med.uni-heidelberg.de.</nlm:affiliation></affiliation></author><author><name sortKey="Rochon, Justine" sort="Rochon, Justine" uniqKey="Rochon J" first="Justine" last="Rochon">Justine Rochon</name><affiliation><nlm:affiliation>Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, D-69120, Heidelberg, Germany. rochon@imbi.uni-heidelberg.de.</nlm:affiliation></affiliation></author><author><name sortKey="Schneeweiss, Andreas" sort="Schneeweiss, Andreas" uniqKey="Schneeweiss A" first="Andreas" last="Schneeweiss">Andreas Schneeweiss</name><affiliation><nlm:affiliation>National Center for Tumor Diseases, University Hospital, Im Neuenheimer Feld 460, D-69120, Heidelberg, Germany. andreas.schneeweiss@med.uni-heidelberg.de.</nlm:affiliation></affiliation></author><author><name sortKey="Muller, Andreas" sort="Muller, Andreas" uniqKey="Muller A" first="Andreas" last="Müller">Andreas Müller</name><affiliation><nlm:affiliation>Community Hospital Karlsruhe, Moltkestraße 90, D-76133, Karlsruhe, Germany. andreas.mueller.fk@klinikum-karlsruhe.de.</nlm:affiliation></affiliation></author><author><name sortKey="Salize, Hans Joachim" sort="Salize, Hans Joachim" uniqKey="Salize H" first="Hans-Joachim" last="Salize">Hans-Joachim Salize</name><affiliation><nlm:affiliation>Central Institute of Mental Health, Mental Health Services Research Group, Medical Faculty Mannheim/Heidelberg University, Mannheim, D-68159, Germany. hans-joachim.salize@zi-mannheim.de.</nlm:affiliation></affiliation></author><author><name sortKey="Joos, Stefanie" sort="Joos, Stefanie" uniqKey="Joos S" first="Stefanie" last="Joos">Stefanie Joos</name><affiliation><nlm:affiliation>Department of General Practice and Health Services Research, University Hospital Heidelberg, Voßstr. 2, D-69115, Heidelberg, Germany. stefanie.joos@uni-tuebingen.de.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Institute of General Practice, University Hospital Tuebingen, Oesterbergstr. 9, D-72074, Tuebingen, Germany. stefanie.joos@uni-tuebingen.de.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Breast Neoplasms (psychology)</term><term>Breast Neoplasms (therapy)</term><term>Complementary Therapies (nursing)</term><term>Data Interpretation, Statistical (MeSH)</term><term>Female (MeSH)</term><term>Genital Neoplasms, Female (psychology)</term><term>Genital Neoplasms, Female (therapy)</term><term>Humans (MeSH)</term><term>Outcome Assessment, Health Care (MeSH)</term><term>Quality Assurance, Health Care (MeSH)</term><term>Quality of Life (MeSH)</term><term>Sample Size (MeSH)</term><term>Social Support (MeSH)</term></keywords><keywords scheme="MESH" qualifier="nursing" xml:lang="en"><term>Complementary Therapies</term></keywords><keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Breast Neoplasms</term><term>Genital Neoplasms, Female</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Breast Neoplasms</term><term>Genital Neoplasms, Female</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Data Interpretation, Statistical</term><term>Female</term><term>Humans</term><term>Outcome Assessment, Health Care</term><term>Quality Assurance, Health Care</term><term>Quality of Life</term><term>Sample Size</term><term>Social Support</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Health-related quality of life (HRQoL) is most adversely affected in cancer patients between diagnosis and the end of chemotherapy. The aim of the Complementary Nursing in Gynecologic Oncology (CONGO) study is to assess the effectiveness of a complex nursing care intervention of CAM to increase HRQoL in cancer patients undergoing chemotherapy.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS/DESIGN</b></p><p>CONGO is a prospective partially randomized patient preference (PRPP) trial including adult women diagnosed with breast and gynecologic cancer starting a new chemotherapy regimen. Patients without strong preferences for CAM will be randomized to usual nursing care or complex nursing care; those patients with strong preferences will be allowed their choice. The intervention consists of three interacting and intertwined elements: CAM nursing intervention packet, counseling on CAM using a resource-oriented approach and evidence-based informational material on CAM. Primary outcome data on participants' HRQoL will be collected from baseline until the end of treatment and long-term follow-up using the EORTC-QLQ-C30. Secondary outcomes include nausea, fatigue, pain, anxiety/depression, social support, self-efficacy, patient competence, spiritual wellbeing, and satisfaction with care. Accompanying research on economic outcomes as well as a mixed-methods process evaluation will be conducted. A total of 590 patients (236 patients in the randomized part of the study and 354 patients in the observational part of the study) will be recruited in the two outpatient clinics. The first analysis step will be the intention-to-treat (ITT) analysis of the randomized part of the trial. A linear mixed model will be used to compare the continuous primary endpoint between the intervention and control arm of the randomized group. The observational part of the trial will be analyzed descriptively. External validity will be assessed by comparing randomized with nonrandomized patients.</p></div><div type="abstract" xml:lang="en"><p><b>DISCUSSION</b></p><p>Cancer patients are increasingly using CAM as supportive cancer care, however, a patient-centered model of care that includes CAM for the patient during chemotherapy still needs to be evaluated. This protocol has been designed to test if the effects of the intervention go beyond potential benefits in quality-of-life outcomes.</p></div><div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b></p><p>German Clinical Trials Register (DRKS), DRKS00006056 (15 April 2014).</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25887713</PMID><DateCompleted><Year>2016</Year><Month>01</Month><Day>27</Day></DateCompleted><DateRevised><Year>2019</Year><Month>12</Month><Day>10</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1745-6215</ISSN><JournalIssue CitedMedium="Internet"><Volume>16</Volume><PubDate><Year>2015</Year><Month>Feb</Month><Day>15</Day></PubDate></JournalIssue><Title>Trials</Title><ISOAbbreviation>Trials</ISOAbbreviation></Journal><ArticleTitle>A complex nursing intervention of complementary and alternative medicine (CAM) to increase quality of life in patients with breast and gynecologic cancer undergoing chemotherapy: study protocol for a partially randomized patient preference trial.</ArticleTitle><Pagination><MedlinePgn>51</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s13063-014-0538-4</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Health-related quality of life (HRQoL) is most adversely affected in cancer patients between diagnosis and the end of chemotherapy. The aim of the Complementary Nursing in Gynecologic Oncology (CONGO) study is to assess the effectiveness of a complex nursing care intervention of CAM to increase HRQoL in cancer patients undergoing chemotherapy.</AbstractText><AbstractText Label="METHODS/DESIGN" NlmCategory="METHODS">CONGO is a prospective partially randomized patient preference (PRPP) trial including adult women diagnosed with breast and gynecologic cancer starting a new chemotherapy regimen. Patients without strong preferences for CAM will be randomized to usual nursing care or complex nursing care; those patients with strong preferences will be allowed their choice. The intervention consists of three interacting and intertwined elements: CAM nursing intervention packet, counseling on CAM using a resource-oriented approach and evidence-based informational material on CAM. Primary outcome data on participants' HRQoL will be collected from baseline until the end of treatment and long-term follow-up using the EORTC-QLQ-C30. Secondary outcomes include nausea, fatigue, pain, anxiety/depression, social support, self-efficacy, patient competence, spiritual wellbeing, and satisfaction with care. Accompanying research on economic outcomes as well as a mixed-methods process evaluation will be conducted. A total of 590 patients (236 patients in the randomized part of the study and 354 patients in the observational part of the study) will be recruited in the two outpatient clinics. The first analysis step will be the intention-to-treat (ITT) analysis of the randomized part of the trial. A linear mixed model will be used to compare the continuous primary endpoint between the intervention and control arm of the randomized group. The observational part of the trial will be analyzed descriptively. External validity will be assessed by comparing randomized with nonrandomized patients.</AbstractText><AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">Cancer patients are increasingly using CAM as supportive cancer care, however, a patient-centered model of care that includes CAM for the patient during chemotherapy still needs to be evaluated. This protocol has been designed to test if the effects of the intervention go beyond potential benefits in quality-of-life outcomes.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">German Clinical Trials Register (DRKS), DRKS00006056 (15 April 2014).</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Klafke</LastName><ForeName>Nadja</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Department of General Practice and Health Services Research, University Hospital Heidelberg, Voßstr. 2, D-69115, Heidelberg, Germany. nadja.klafke@med.uni-heidelberg.de.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mahler</LastName><ForeName>Cornelia</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of General Practice and Health Services Research, University Hospital Heidelberg, Voßstr. 2, D-69115, Heidelberg, Germany. cornelia.mahler@med.uni-heidelberg.de.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>von Hagens</LastName><ForeName>Cornelia</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Gynaecological Endocrinology and Reproductive Medicine, University Women's Hospital Heidelberg, Im Neuenheimer Feld 440, D-69120, Heidelberg, Germany. cornelia.von.hagens@med.uni-heidelberg.de.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rochon</LastName><ForeName>Justine</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 305, D-69120, Heidelberg, Germany. rochon@imbi.uni-heidelberg.de.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schneeweiss</LastName><ForeName>Andreas</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>National Center for Tumor Diseases, University Hospital, Im Neuenheimer Feld 460, D-69120, Heidelberg, Germany. andreas.schneeweiss@med.uni-heidelberg.de.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Müller</LastName><ForeName>Andreas</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Community Hospital Karlsruhe, Moltkestraße 90, D-76133, Karlsruhe, Germany. andreas.mueller.fk@klinikum-karlsruhe.de.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Salize</LastName><ForeName>Hans-Joachim</ForeName><Initials>HJ</Initials><AffiliationInfo><Affiliation>Central Institute of Mental Health, Mental Health Services Research Group, Medical Faculty Mannheim/Heidelberg University, Mannheim, D-68159, Germany. hans-joachim.salize@zi-mannheim.de.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Joos</LastName><ForeName>Stefanie</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of General Practice and Health Services Research, University Hospital Heidelberg, Voßstr. 2, D-69115, Heidelberg, Germany. stefanie.joos@uni-tuebingen.de.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Institute of General Practice, University Hospital Tuebingen, Oesterbergstr. 9, D-72074, Tuebingen, Germany. stefanie.joos@uni-tuebingen.de.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>DRKS</DataBankName><AccessionNumberList><AccessionNumber>DRKS00006056</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>02</Month><Day>15</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Trials</MedlineTA><NlmUniqueID>101263253</NlmUniqueID><ISSNLinking>1745-6215</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D001943" MajorTopicYN="N">Breast Neoplasms</DescriptorName><QualifierName UI="Q000523" MajorTopicYN="N">psychology</QualifierName><QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000529" MajorTopicYN="N">Complementary Therapies</DescriptorName><QualifierName UI="Q000451" MajorTopicYN="Y">nursing</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003627" MajorTopicYN="N">Data Interpretation, Statistical</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005833" MajorTopicYN="N">Genital Neoplasms, Female</DescriptorName><QualifierName UI="Q000523" MajorTopicYN="N">psychology</QualifierName><QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D017063" MajorTopicYN="N">Outcome Assessment, Health Care</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011785" MajorTopicYN="N">Quality Assurance, Health Care</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011788" MajorTopicYN="Y">Quality of Life</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018401" MajorTopicYN="N">Sample Size</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012944" MajorTopicYN="N">Social Support</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate 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