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Complementary Therapy in Home Palliative Care Patients and Their Caregivers
NCT04052074
Introduction:
There is an increase on cancer prevalence and, consequently, a higher number of people that require palliative care, making an influence on the family and the main carer.
Objectives:
* To evaluate the efficiency and cost-effectiveness of a music intervention program, applied as a complementary therapy, in oncological palliative care patients and carers at home, compared to current treatment.
* To assess if patients in the intervention group submit significant differences regarding: pain, anxiety, depression, modo, insomnia, and life quality.
* To assess if carers in the intervention group present significant differences regarding the Caregiver Burden Scale and life quality.
* To evaluate patients and carers satisfaction on the therapeutic intervention.
* To estimate the cost-effectiveness of the intervention.
Method:
Randomised, double-blind, multi-centre clinical trial in the field of primary health care, conducted in 5 clinical management units belonging to Málaga-Guadalhorce health district and performed in oncological palliative care patients and carers. Two samples of 40 palliative care patients and two samples of 41 carers. The intervention group will undergo a 7-days intervention with music sessions, the control group will be given seven sessions of retraining in therapeutical education. Objectives will be evaluated through the following tools: Edmonton Scale, Symptom Assessment System, EORTC QLQ-C30, Caregiver Burden Scale, Pittsburgh Sleep Quality Index, Accelerometer, Epworth Sleepiness Scale (ESS), The Quality of Life Family Version, Client Satisfaction Questionnaire and Economical valuation.
To assess the objectives evaluations will be performed through home visit, both pre-intervention and a week after the beginning of the intervention for both groups. A follow-up visit will be made a month after the intervention to regard some economical parameters.
Statistical analysis:
The basal values of both groups will be compared. These values will be compared before and after the intervention, in the control and intervention group through Student t-test for normal continuous variables, and through Wilcoxon t-test for paired data in not normal continuous variables. In addition to the bivariated analysis, a multiple lineal regression will be carried out. The economical valuation will be a cost-effectiveness analysis. For each group we will measure cost, incremental cost, AVAC effectiveness, incremental effectiveness, dominance and, in case there is none, the results will be expressed in terms of incremental cost-effectiveness. To assess the costs, direct sanitary costs and intervention related costs will be considered.
SPSS 23 will be the statistical software to use, along with Epidat 3.01. 95% confidence range will make p values under 0,05 (p\<0.05) statistically significant.
Music TherapyCaregiversPalliative Care
Andaluz Health Service160 participantsStarted Sep 2019 