Complementary music therapy for cancer patients in at-home palliative care and their caregivers: protocol for a multicentre randomised controlled trial.
Identifieur interne : 000333 ( Main/Exploration ); précédent : 000332; suivant : 000334Complementary music therapy for cancer patients in at-home palliative care and their caregivers: protocol for a multicentre randomised controlled trial.
Auteurs : Inmaculada Valero-Cantero [Espagne] ; Francisco Javier Martínez-Valero [Royaume-Uni] ; Milagrosa Espinar-Toledo [Espagne] ; Cristina Casals [Espagne] ; Francisco Javier Bar N-L Pez [Espagne] ; María Ngeles Vázquez-Sánchez [Espagne]Source :
- BMC palliative care [ 1472-684X ] ; 2020.
Descripteurs français
- KwdFr :
- Adulte (MeSH), Aidants (psychologie), Femelle (MeSH), Humains (MeSH), Musicothérapie (méthodes), Musicothérapie (normes), Mâle (MeSH), Méthode en double aveugle (MeSH), Protocoles cliniques (MeSH), Services de soins à domicile (normes), Soins palliatifs (normes), Tumeurs (psychologie), Tumeurs (thérapie).
- MESH :
- méthodes : Musicothérapie.
- normes : Musicothérapie, Services de soins à domicile, Soins palliatifs.
- psychologie : Aidants, Tumeurs.
- thérapie : Tumeurs.
- Adulte, Femelle, Humains, Mâle, Méthode en double aveugle, Protocoles cliniques.
English descriptors
- KwdEn :
- MESH :
- methods : Music Therapy.
- psychology : Caregivers, Neoplasms.
- standards : Home Care Services, Music Therapy, Palliative Care.
- therapy : Neoplasms.
- Adult, Clinical Protocols, Double-Blind Method, Female, Humans, Male.
Abstract
BACKGROUND
Patients with advanced cancer, receiving at-home palliative care, are subject to numerous symptoms that are changeable and often require attention, a stressful situation that also impacts on the family caregiver. It has been suggested that music therapy may benefit both the patient and the caregiver. We propose a study to analyse the efficacy and cost utility of a music intervention programme, applied as complementary therapy, for cancer patients in palliative care and for their at-home caregivers, compared to usual treatment.
METHOD
A randomised, double-blind, multicentre clinical trial will be performed in cancer patients in at-home palliative care and their family caregivers. The study population will include two samples of 40 patients and two samples of 41 caregivers. Participants will be randomly assigned either to the intervention group or to the control group. The intervention group will receive a seven-day programme including music sessions, while the control group will receive seven sessions of (spoken word) therapeutic education. In this study, the primary outcome measure is the assessment of patients' symptoms, according to the Edmonton Symptom Assessment System, and of the overload experienced by family caregivers, measured by the Caregiver Strain Index. The secondary outcomes considered will be the participants' health-related quality of life, their satisfaction with the intervention, and an economic valuation.
DISCUSSION
This study is expected to enhance our understanding of the efficacy and cost-utility of music therapy for cancer patients in palliative care and for their family caregivers. The results of this project are expected to be applicable and transferrable to usual clinical practice for patients in home palliative care and for their caregivers. The approach described can be incorporated as an additional therapeutic resource within comprehensive palliative care. To our knowledge, no previous high quality studies, based on a double-blind clinical trial, have been undertaken to evaluate the cost-effectiveness of music therapy. The cost-effectiveness of the project will provide information to support decision making, thereby improving the management of health resources and their use within the health system.
TRIAL REGISTRATION
The COMTHECARE study is registered at Clinical Trials.gov, NCT04052074. Registered 9 August, 2019.
DOI: 10.1186/s12904-020-00570-9
PubMed: 32359361
PubMed Central: PMC7196216
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Complementary music therapy for cancer patients in at-home palliative care and their caregivers: protocol for a multicentre randomised controlled trial.</title><author><name sortKey="Valero Cantero, Inmaculada" sort="Valero Cantero, Inmaculada" uniqKey="Valero Cantero I" first="Inmaculada" last="Valero-Cantero">Inmaculada Valero-Cantero</name><affiliation wicri:level="1"><nlm:affiliation>Puerta Blanca Clinical Management Unit, Malaga-Guadalhorce Health District, Malaga, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Puerta Blanca Clinical Management Unit, Malaga-Guadalhorce Health District, Malaga</wicri:regionArea><wicri:noRegion>Malaga</wicri:noRegion></affiliation></author><author><name sortKey="Martinez Valero, Francisco Javier" sort="Martinez Valero, Francisco Javier" uniqKey="Martinez Valero F" first="Francisco Javier" last="Martínez-Valero">Francisco Javier Martínez-Valero</name><affiliation wicri:level="2"><nlm:affiliation>Midlothian Foot Care, Dalkeith and National Health Service, Lothian, Scotland.</nlm:affiliation><country>Royaume-Uni</country><placeName><region type="country">Écosse</region></placeName><wicri:cityArea>Midlothian Foot Care, Dalkeith and National Health Service, Lothian</wicri:cityArea></affiliation></author><author><name sortKey="Espinar Toledo, Milagrosa" sort="Espinar Toledo, Milagrosa" uniqKey="Espinar Toledo M" first="Milagrosa" last="Espinar-Toledo">Milagrosa Espinar-Toledo</name><affiliation wicri:level="1"><nlm:affiliation>"Rincón de la Victoria" Clinical Management Unit, Malaga-Guadalhorce Health District, Malaga, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>"Rincón de la Victoria" Clinical Management Unit, Malaga-Guadalhorce Health District, Malaga</wicri:regionArea><wicri:noRegion>Malaga</wicri:noRegion></affiliation></author><author><name sortKey="Casals, Cristina" sort="Casals, Cristina" uniqKey="Casals C" first="Cristina" last="Casals">Cristina Casals</name><affiliation wicri:level="1"><nlm:affiliation>MOVE-IT Research group and Department of Physical Education, Faculty of Education Sciences. 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Institute of Biomedical Research in Malaga (IBIMA), University of Malaga, Malaga, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Preventive Medicine, Public Health and Science History. 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Biomedical Research and Innovation Institute of Cadiz (INiBICA) Research Unit, Puerta del Mar University Hospital, University of Cadiz, Cádiz, Spain. cristina.casals@uca.es.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>MOVE-IT Research group and Department of Physical Education, Faculty of Education Sciences. Biomedical Research and Innovation Institute of Cadiz (INiBICA) Research Unit, Puerta del Mar University Hospital, University of Cadiz, Cádiz</wicri:regionArea><wicri:noRegion>Cádiz</wicri:noRegion></affiliation></author><author><name sortKey="Bar N L Pez, Francisco Javier" sort="Bar N L Pez, Francisco Javier" uniqKey="Bar N L Pez F" first="Francisco Javier" last="Bar N-L Pez">Francisco Javier Bar N-L Pez</name><affiliation wicri:level="4"><nlm:affiliation>Department of Preventive Medicine, Public Health and Science History. Institute of Biomedical Research in Malaga (IBIMA), University of Malaga, Malaga, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Preventive Medicine, Public Health and Science History. Institute of Biomedical Research in Malaga (IBIMA), University of Malaga, Malaga</wicri:regionArea><orgName type="university">Université de Malaga</orgName><placeName><settlement type="city">Malaga</settlement><region nuts="2" type="region">Andalousie</region></placeName></affiliation></author><author><name sortKey="Vazquez Sanchez, Maria Ngeles" sort="Vazquez Sanchez, Maria Ngeles" uniqKey="Vazquez Sanchez M" first="María Ngeles" last="Vázquez-Sánchez">María Ngeles Vázquez-Sánchez</name><affiliation wicri:level="4"><nlm:affiliation>Department of Nursing, Faculty of Health Sciences, University of Malaga, Malaga, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Nursing, Faculty of Health Sciences, University of Malaga, Malaga</wicri:regionArea><orgName type="university">Université de Malaga</orgName><placeName><settlement type="city">Malaga</settlement><region nuts="2" type="region">Andalousie</region></placeName></affiliation></author></analytic><series><title level="j">BMC palliative care</title><idno type="eISSN">1472-684X</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult (MeSH)</term><term>Caregivers (psychology)</term><term>Clinical Protocols (MeSH)</term><term>Double-Blind Method (MeSH)</term><term>Female (MeSH)</term><term>Home Care Services (standards)</term><term>Humans (MeSH)</term><term>Male (MeSH)</term><term>Music Therapy (methods)</term><term>Music Therapy (standards)</term><term>Neoplasms (psychology)</term><term>Neoplasms (therapy)</term><term>Palliative Care (standards)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte (MeSH)</term><term>Aidants (psychologie)</term><term>Femelle (MeSH)</term><term>Humains (MeSH)</term><term>Musicothérapie (méthodes)</term><term>Musicothérapie (normes)</term><term>Mâle (MeSH)</term><term>Méthode en double aveugle (MeSH)</term><term>Protocoles cliniques (MeSH)</term><term>Services de soins à domicile (normes)</term><term>Soins palliatifs (normes)</term><term>Tumeurs (psychologie)</term><term>Tumeurs (thérapie)</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Music Therapy</term></keywords><keywords scheme="MESH" qualifier="méthodes" xml:lang="fr"><term>Musicothérapie</term></keywords><keywords scheme="MESH" qualifier="normes" xml:lang="fr"><term>Musicothérapie</term><term>Services de soins à domicile</term><term>Soins palliatifs</term></keywords><keywords scheme="MESH" qualifier="psychologie" xml:lang="fr"><term>Aidants</term><term>Tumeurs</term></keywords><keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Caregivers</term><term>Neoplasms</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Home Care Services</term><term>Music Therapy</term><term>Palliative Care</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Neoplasms</term></keywords><keywords scheme="MESH" qualifier="thérapie" xml:lang="fr"><term>Tumeurs</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Clinical Protocols</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Protocoles cliniques</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Patients with advanced cancer, receiving at-home palliative care, are subject to numerous symptoms that are changeable and often require attention, a stressful situation that also impacts on the family caregiver. It has been suggested that music therapy may benefit both the patient and the caregiver. We propose a study to analyse the efficacy and cost utility of a music intervention programme, applied as complementary therapy, for cancer patients in palliative care and for their at-home caregivers, compared to usual treatment.</p></div><div type="abstract" xml:lang="en"><p><b>METHOD</b></p><p>A randomised, double-blind, multicentre clinical trial will be performed in cancer patients in at-home palliative care and their family caregivers. The study population will include two samples of 40 patients and two samples of 41 caregivers. Participants will be randomly assigned either to the intervention group or to the control group. The intervention group will receive a seven-day programme including music sessions, while the control group will receive seven sessions of (spoken word) therapeutic education. In this study, the primary outcome measure is the assessment of patients' symptoms, according to the Edmonton Symptom Assessment System, and of the overload experienced by family caregivers, measured by the Caregiver Strain Index. The secondary outcomes considered will be the participants' health-related quality of life, their satisfaction with the intervention, and an economic valuation.</p></div><div type="abstract" xml:lang="en"><p><b>DISCUSSION</b></p><p>This study is expected to enhance our understanding of the efficacy and cost-utility of music therapy for cancer patients in palliative care and for their family caregivers. The results of this project are expected to be applicable and transferrable to usual clinical practice for patients in home palliative care and for their caregivers. The approach described can be incorporated as an additional therapeutic resource within comprehensive palliative care. To our knowledge, no previous high quality studies, based on a double-blind clinical trial, have been undertaken to evaluate the cost-effectiveness of music therapy. The cost-effectiveness of the project will provide information to support decision making, thereby improving the management of health resources and their use within the health system.</p></div><div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b></p><p>The COMTHECARE study is registered at Clinical Trials.gov, NCT04052074. Registered 9 August, 2019.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32359361</PMID><DateCompleted><Year>2020</Year><Month>12</Month><Day>23</Day></DateCompleted><DateRevised><Year>2020</Year><Month>12</Month><Day>23</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1472-684X</ISSN><JournalIssue CitedMedium="Internet"><Volume>19</Volume><Issue>1</Issue><PubDate><Year>2020</Year><Month>May</Month><Day>02</Day></PubDate></JournalIssue><Title>BMC palliative care</Title><ISOAbbreviation>BMC Palliat Care</ISOAbbreviation></Journal><ArticleTitle>Complementary music therapy for cancer patients in at-home palliative care and their caregivers: protocol for a multicentre randomised controlled trial.</ArticleTitle><Pagination><MedlinePgn>61</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s12904-020-00570-9</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Patients with advanced cancer, receiving at-home palliative care, are subject to numerous symptoms that are changeable and often require attention, a stressful situation that also impacts on the family caregiver. It has been suggested that music therapy may benefit both the patient and the caregiver. We propose a study to analyse the efficacy and cost utility of a music intervention programme, applied as complementary therapy, for cancer patients in palliative care and for their at-home caregivers, compared to usual treatment.</AbstractText><AbstractText Label="METHOD" NlmCategory="METHODS">A randomised, double-blind, multicentre clinical trial will be performed in cancer patients in at-home palliative care and their family caregivers. The study population will include two samples of 40 patients and two samples of 41 caregivers. Participants will be randomly assigned either to the intervention group or to the control group. The intervention group will receive a seven-day programme including music sessions, while the control group will receive seven sessions of (spoken word) therapeutic education. In this study, the primary outcome measure is the assessment of patients' symptoms, according to the Edmonton Symptom Assessment System, and of the overload experienced by family caregivers, measured by the Caregiver Strain Index. The secondary outcomes considered will be the participants' health-related quality of life, their satisfaction with the intervention, and an economic valuation.</AbstractText><AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">This study is expected to enhance our understanding of the efficacy and cost-utility of music therapy for cancer patients in palliative care and for their family caregivers. The results of this project are expected to be applicable and transferrable to usual clinical practice for patients in home palliative care and for their caregivers. The approach described can be incorporated as an additional therapeutic resource within comprehensive palliative care. To our knowledge, no previous high quality studies, based on a double-blind clinical trial, have been undertaken to evaluate the cost-effectiveness of music therapy. The cost-effectiveness of the project will provide information to support decision making, thereby improving the management of health resources and their use within the health system.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">The COMTHECARE study is registered at Clinical Trials.gov, NCT04052074. Registered 9 August, 2019.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Valero-Cantero</LastName><ForeName>Inmaculada</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Puerta Blanca Clinical Management Unit, Malaga-Guadalhorce Health District, Malaga, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Martínez-Valero</LastName><ForeName>Francisco Javier</ForeName><Initials>FJ</Initials><AffiliationInfo><Affiliation>Midlothian Foot Care, Dalkeith and National Health Service, Lothian, Scotland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Espinar-Toledo</LastName><ForeName>Milagrosa</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>"Rincón de la Victoria" Clinical Management Unit, Malaga-Guadalhorce Health District, Malaga, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Casals</LastName><ForeName>Cristina</ForeName><Initials>C</Initials><Identifier Source="ORCID">http://orcid.org/0000-0002-6992-0492</Identifier><AffiliationInfo><Affiliation>MOVE-IT Research group and Department of Physical Education, Faculty of Education Sciences. Biomedical Research and Innovation Institute of Cadiz (INiBICA) Research Unit, Puerta del Mar University Hospital, University of Cadiz, Cádiz, Spain. cristina.casals@uca.es.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Barón-López</LastName><ForeName>Francisco Javier</ForeName><Initials>FJ</Initials><AffiliationInfo><Affiliation>Department of Preventive Medicine, Public Health and Science History. Institute of Biomedical Research in Malaga (IBIMA), University of Malaga, Malaga, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vázquez-Sánchez</LastName><ForeName>María Ángeles</ForeName><Initials>MÁ</Initials><AffiliationInfo><Affiliation>Department of Nursing, Faculty of Health Sciences, University of Malaga, Malaga, Spain.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT04052074</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>AP-0157-2018</GrantID><Agency>Consejería de Salud, Junta de Andalucía</Agency><Country></Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>05</Month><Day>02</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>BMC Palliat Care</MedlineTA><NlmUniqueID>101088685</NlmUniqueID><ISSNLinking>1472-684X</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D017028" MajorTopicYN="N">Caregivers</DescriptorName><QualifierName UI="Q000523" MajorTopicYN="Y">psychology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002985" MajorTopicYN="N">Clinical Protocols</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006699" MajorTopicYN="N">Home Care Services</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009147" MajorTopicYN="N">Music Therapy</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D009369" MajorTopicYN="N">Neoplasms</DescriptorName><QualifierName UI="Q000523" MajorTopicYN="N">psychology</QualifierName><QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D010166" MajorTopicYN="N">Palliative Care</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Cost efficiency analysis</Keyword><Keyword MajorTopicYN="N">Family caregiver</Keyword><Keyword MajorTopicYN="N">Home care</Keyword><Keyword MajorTopicYN="N">Nurses</Keyword><Keyword MajorTopicYN="N">Oncology</Keyword><Keyword MajorTopicYN="N">Palliative therapy</Keyword><Keyword MajorTopicYN="N">Patient care</Keyword><Keyword MajorTopicYN="N">Quality of life</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>03</Month><Day>14</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>04</Month><Day>27</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>5</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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