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01-12-2020 | Care | Study protocol

Complementary music therapy for cancer patients in at-home palliative care and their caregivers: protocol for a multicentre randomised controlled trial

Authors: Inmaculada Valero-Cantero, Francisco Javier Martínez-Valero, Milagrosa Espinar-Toledo, Cristina Casals, Francisco Javier Barón-López, María Ángeles Vázquez-Sánchez

Published in: BMC Palliative Care | Issue 1/2020

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.

Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Piñeros M, et al. Global Cancer observatory: Cancer today. Lyon, France: International Agency for Research on Cancer; 2018. https://gco.iarc.fr/today, Accessed 20 May 2019.

Deaths according to the Cause of Death Year 2016. Statistics National Institute. http://www.ine.es/prensa/edcm_2016.pdf. Accessed 15 May 2019.

Siegel RL, Miller KD, Jemal A. Cancer statistic, 2019. CA Cancer J Clin. 2019;69(1):7–34. https://doi.org/10.3322/caac.21551.CrossRefPubMed

Hui D, Hannon BL, Zimmermann C, Bruera E. Improving patient and caregiver outcomes in oncology: team-based, timely, and targeted palliative care. CA Cancer J Clin. 2018;68(5):356–76. https://doi.org/10.3322/caac.21490.CrossRefPubMedPubMedCentral

World Health Organization. Definition of Palliative Care. https://www.who.int/cancer/palliative/definition/en/. Accessed 1 May 2019.

Kaasa S, Loge JH, Aapro M, Albreht T, Anderson R, Bruera E, et al. Integration of oncology and palliative care: a lancet oncology commission. Lancet Oncol. 2018;19(11):e588–653. https://doi.org/10.1016/S1470-2045(18)30415-7.CrossRefPubMed

Yates P. Symptom management and palliative Care for Patients with Cancer. Nurs Clin North Am. 2017;52(1):179–91. https://doi.org/10.1016/j.cnur.2016.10.006.CrossRefPubMed

Miceli J, Geller D, Tsung A, Hecht CL, Wang Y, Pathak R, et al. Illness perceptions and perceived stress in patients with advanced gastrointestinal cancer. Psychooncology. 2019;28(7):1513–9. https://doi.org/10.1002/pon.5108.CrossRefPubMedPubMedCentral

Charalambous A, Giannakopoulou M, Bozas E, Paikousis L. Parallel and serial mediation analysis between pain, anxiety, depression, fatigue and nausea, vomiting and retching within a randomised controlled trial in patients with breast and prostate cancer. BMJ Open. 2019;9(1):e026809. https://doi.org/10.1136/bmjopen-2018-026809.CrossRefPubMedPubMedCentral

10.

Syrjala KL, Jensen MP, Mendoza ME, Yi JC, Fisher HM, Keefe FL. Psychological and behavioral approaches to Cancer pain management. J Clin Oncol. 2014;32(16):1703–11. https://doi.org/10.1200/JCO.2013.54.4825.CrossRefPubMedPubMedCentral

11.

Maltby KF, Sanderson CR, Lobb EA, Phillips JL. Sleep disturbances in caregivers of patients with advanced cancer: a systematic review. Palliat Support Care. 2017;15(1):125–40. https://doi.org/10.1017/S1478951516001024.CrossRefPubMed

12.

Choi S, Seo J. Analysis of caregiver burden in palliative care: an integrated review. Nurs Forum. 2019;54(2):280–90. https://doi.org/10.1111/nuf.12328.CrossRefPubMed

13.

Perpiñá-Galvañ J, Orts-Beneito N, Fernández-Alcántara M, García-Sanjuán S, García-Caro MP, Cabañero-Martínez MJ. Level of burden and health-related quality of life in caregivers of palliative care patients. Int J Environ Res Public Health. 2019;16(23):E4806. https://doi.org/10.3390/ijerph16234806.CrossRefPubMed

14.

Oechsle K, Ullrich A, Marx G, Benze G, Wowretzko F, Zhang Y, et al. Prevalence and predictors of distress, anxiety, depression, and quality of life in bereaved family caregivers of patients with advanced Cancer. Am J Hosp Palliat Care. 2020;37(3):201–13. https://doi.org/10.1177/1049909119872755.CrossRefPubMed

15.

Peretz I, Gagnon L, Bouchard B. Music and emotion: perceptual determinants, immediacy, and isolation after brain damage. Cognition. 1998;68:111–41. https://doi.org/10.1016/S0010-0277(98)00043-2.CrossRefPubMed

16.

Mizuno T, Sugishita M. Neural correlates underlying perception of tonality-related emotional components. Neuroreport. 2007;18:1651–5. https://doi.org/10.1097/WNR.0b013e3282f0b787.CrossRefPubMed

17.

Blood AJ, Zatorre RJ. Intensely pleasurable responses to music correlate with activity in brain regions implicated in reward and emotion. Proc Natl Acad Sci U S A. 2001;98:11818–23. https://doi.org/10.1073/pnas.191355898.CrossRefPubMedPubMedCentral

18.

Bulechek GM, Butcher HK, Dochterman JM, Wagner CM. Classification of nursing interventions NIC. 6a ed. Barcelona: Elsevier; 2014.

19.

Krishnaswamy P, Nair S. Effect of music therapy on pain and anxiety levels of Cancer patients: a pilot study. Indian J Palliat Care. 2016;22(3):307–11. https://doi.org/10.4103/0973-1075.185042.CrossRefPubMedPubMedCentral

20.

Arruda MA, Garcia MA, Garcia JB. Evaluation of the effects of music and poetry in oncologic pain relief: a randomized clinical trial. J Palliat Med. 2016;9:943–8. https://doi.org/10.1089/jpm.2015.0528.CrossRef

21.

Gallagher LM, Lagman R, Rybicki L. Outcomes of music therapy interventions on symptom Management in Palliative Medicine Patients. Am J Hosp Palliat Care. 2018;35(2):250–7. https://doi.org/10.1177/1049909117696723.CrossRefPubMed

22.

Preissler P, Kordovan S, Ullrich A, Bokemeyer C, Oechsle K. Favored subjects and psychosocial needs in music therapy in terminally ill cancer patients: a content analysis. BMC Palliat Care. 2016;15:48. https://doi.org/10.1186/s12904-016-0122-7.CrossRefPubMedPubMedCentral

23.

Warth M, Keßler J, Hillecke TK, Bardenheuer HJ. Music therapy in palliative care. Dtsch Arzteblatt Int. 2015;112(46):788–94. https://doi.org/10.3238/arztebl.2015.0788.CrossRef

24.

Porter S, McConnell T, Clarke M, Kirkwood J, Hughes N, Graham-Wisener L, et al. A critical realist evaluation of a music therapy intervention in palliative care. BMC Palliat Care. 2017;16(1):70. https://doi.org/10.1186/s12904-017-0253-5.CrossRefPubMedPubMedCentral

25.

Pommeret S, Chrusciel J, Verlaine C, Filbet M, Tricou C, Sanchez S, Hannetel L. Music in palliative care: a qualitative study with patients suffering from cancer. BMC Palliat Care. 2019;18(1):78. https://doi.org/10.1186/s12904-019-0461-2.CrossRefPubMedPubMedCentral

26.

McConnell T, Scott D, Porter S. Music therapy for end-of-life care: an updated systematic review. Palliat Med. 2016;30(9):877–83. https://doi.org/10.1177/0269216316635387.CrossRefPubMed

27.

Lee JH. The effects of music on pain: a meta-analysis. J Pain Symptom Manag. 2019;S0885-3924(19):31064. https://doi.org/10.1016/j.jpainsymman.2019.12.359.CrossRef

28.

Keenan A, Keithley JK. Integrative review: effects of music on Cancer pain in adults. Oncol Nurs Forum. 2015;42(6):E368–75. https://doi.org/10.1188/15.ONF.E368-E375.CrossRefPubMed

29.

Bradt J, Dileo C, Magill L, Teague A. Music interventions for improving psychological and physical outcomes in cancer patients. Cochrane Database Syst Rev. 2016;8:CD006911. https://doi.org/10.1002/14651858.CD006911.pub3.CrossRef

30.

Schmid W, Rosland JH, von Hofacker S, Hunskår I, Bruvik F. Patient's and health care provider's perspectives on music therapy in palliative care - an integrative review. BMC Palliat Care. 2018;17(1):32. https://doi.org/10.1186/s12904-018-0286-4.CrossRefPubMedPubMedCentral

31.

Kordovan S, Preissler P, Kamphausen A, Bokemeyer C, Oechsle K. Prospective study on music therapy in terminally ill Cancer patients during specialized inpatient palliative care. J Palliat Med. 2016;19(4):394–9. https://doi.org/10.1089/jpm.2015.0384.CrossRefPubMed

32.

Qi He Mabel L, Drury VB, Hong PW. The experience and expectations of terminally ill patients receiving music therapy in the palliative setting: a systematic review. JBI Libr Syst Rev. 2010;8(27):1088–111. https://doi.org/10.11124/01938924-201008270-00001.CrossRefPubMed

33.

Gallagher LM, Lagman R, Bates D, Edsall M, Eden P, Janaitis J, Rybicki L. Perceptions of family members of palliative medicine and hospice patients who experienced music therapy. Support Care Cancer. 2017;25(6):1769–78. https://doi.org/10.1007/s00520-017-3578-y.CrossRefPubMed

34.

Sales CA, da Silva VA, Pilger C, Marcon SS. Music in human terminality: the family members' conceptions. Rev Esc Enferm USP. 2011;45(1):138–45. https://doi.org/10.1590/S0080-62342011000100019.CrossRefPubMed

35.

O'Callaghan CC, McDermott F, Reid P, Michael N, Hudson P, Zalcberg JR, et al. Music’s relevance for people affected by Cancer: a meta-ethnography and implications for music therapists. J Music Ther. 2016;53(4):398–429. https://doi.org/10.1093/jmt/thw013.CrossRefPubMed

36.

Potvin N, Bradt J, Ghetti C. A theoretical model of resource-oriented music therapy with informal hospice caregivers during pre-bereavement. J Music Ther. 2018;55(1):27–61. https://doi.org/10.1093/jmt/thx019.CrossRefPubMed

37.

DeLoach Walworth D. Procedural-support music therapy in the healthcare setting: a cost-effectiveness analysis. J Pediatr Nurs. 2005;20(4):276–84. https://doi.org/10.1016/j.pedn.2005.02.016.CrossRefPubMed

38.

Romo R, Gifford L. A cost-benefit analysis of music therapy in a home hospice. Nurs Econ. 2007;25(6):353–8.PubMed

39.

Yennurajalingam S, Reddy A, Tannir NM, Chisholm GB, Lee RT, Lopez G. High-dose Asian ginseng (Panax Ginseng) for cancer-related fatigue: a preliminary report. Integr Cancer Ther. 2015;14(5):419–27. https://doi.org/10.1177/1534735415580676.CrossRefPubMed

40.

Hanser SB, Butterfield-Whitcomb J, Kawata M, Collins BE. Home-based music strategies with individuals who have dementia and their family caregivers. J Music Ther. 2011;48(1):2–27. https://doi.org/10.1093/jmt/48.1.2.CrossRefPubMed

41.

Andaluz Palliative Care Plan. http://www.juntadeandalucia.es/servicioandaluzdesalud/contenidos/gestioncalidad/Plan_Cuidados_Paliativos.pdf. Accessed 05 May 2019.

42.

Palliative Care Units. Standards and Recommendations. 2009. http://www.msc.es/organizacion/sns/planCalidadSNS/docs/cuidadospaliativos.pdf. Accessed 23 May 2019.

43.

Carvajal A, Hribernik N, Duarte E, Sanz-Rubiales A, Centeno C. The Spanish version of the Edmonton symptom assessment system-revised (ESAS-r): first psychometric analysis involving patients with advanced cancer. J Pain Symptom Manag. 2013;45(1):129–36. https://doi.org/10.1016/j.jpainsymman.2012.01.014.CrossRef

44.

Arrarás JI, Villafranca E, Arias F, Domínguez MA, Lainez N, Manterola A, et al. The EORTC quality of life questionnaire QLO-C30 (version 3.0). Validation study for spanish prostate cancer patients. Arch Esp Urol. 2008;61(8):949–54.

45.

Slater CH, Bick D. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. JAMA. 1994;271(17):1377. https://doi.org/10.1001/jama.1994.03510410095046.CrossRef

46.

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36. https://doi.org/10.1007/s11136-011-9903-x.CrossRefPubMedPubMedCentral

47.

Drummond MJ, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL. Methods for the economic evaluation of health care programmes. 3rd ed. Oxford: Oxford University Press; 2005.

48.

Roberts RE, Attkisson CC. Assessing client satisfaction among Hispanics. Eval Program Plann. 1983;6(3–4):401–13. https://doi.org/10.1016/0149-7189(83)90019-8.CrossRefPubMed

49.

Robinson BC. Validation of a caregiver strain index. J Gerontol. 1983;38(3):344–8. https://doi.org/10.1093/geronj/38.3.344.CrossRefPubMed

50.

López SR, Morqal MS. Validation of the caregiver strain index in Spanish population. Enfer Comun. 2005;1(1):12–7.

51.

Hoffman L, Marquis J, Poston D, Summers JA, Turnbull A. Assessing family outcomes: psychometric evaluation of the beach center family quality of life scale. J Marriage Fam. 2006;68(4):1069–83. https://doi.org/10.1111/j.1741-3737.2006.00314.x.CrossRef

52.

Benitez-Rosario MA, Caceres-Miranda R, Aguirre-Jaime A. Spanish validation of the care evaluation scale for measuring the quality of structure and process of palliative care from the family perspective. J Pain Symptom Manag. 2016;51(3):609–14. https://doi.org/10.1016/j.jpainsymman.2015.11.002.CrossRef

53.

López Bastida J, Oliva J, Antoñanzas F, García-Altés A, Gisbert R, Mar J, Puig-Junoy J. A proposed guideline for economic evaluation of health technologies. Gac Sanit. 2010;24(2):154–70.CrossRefPubMed

Title: Complementary music therapy for cancer patients in at-home palliative care and their caregivers: protocol for a multicentre randomised controlled trial
Authors: Inmaculada Valero-Cantero
Francisco Javier Martínez-Valero
Milagrosa Espinar-Toledo
Cristina Casals
Francisco Javier Barón-López
María Ángeles Vázquez-Sánchez
Publication date: 01-12-2020
Publisher: BioMed Central
Keyword: Care
Published in: BMC Palliative Care / Issue 1/2020
Electronic ISSN: 1472-684X
DOI: https://doi.org/10.1186/s12904-020-00570-9

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Complementary music therapy for cancer patients in at-home palliative care and their caregivers: protocol for a multicentre randomised controlled trial

Abstract

Background

Method

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Method

Discussion

Trial registration

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