Abstract
BackgroundPatients 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.MethodA 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.DiscussionThis 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 registrationThe COMTHECARE study is registered at Clinical Trials.gov, NCT04052074. Registered 9 August, 2019.
Highlights
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 impacts on the family caregiver
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
According to a 2018 report by the Spanish Society of Medical Oncology, based on data published by the National Statistics Institute (INE), in 2016 almost 113,000 people died in Spain of cancerrelated causes (27.5% of deaths)
Summary
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 impacts on the family caregiver. According to a 2018 report by the Spanish Society of Medical Oncology, based on data published by the National Statistics Institute (INE), in 2016 almost 113,000 people died in Spain of cancerrelated causes (27.5% of deaths) This figure was 1.4% higher than in 2015 and by 2035 it is expected to reach almost 160,000 [2]. It is important to realise that palliative care should not be limited to the last days of life, but provided progressively during the course of the disease, in accordance with the needs of the patient and family members Among other aspects, it should include relief from pain and other symptoms, together with attention to spiritual and psychological questions, helping patients live as actively as possible until death and providing support to help the family adapt, both during the illness and in bereavement [5, 6]
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