Complementary Therapy in Home Palliative Care Patients and Their Caregivers

Summary

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.

Conditions

• Music Therapy
• Caregivers
• Palliative Care

Interventions

OTHER

Music Therapy

We are aiming to use music therapy, with pre-recorded favoured music, as a complementary treatment in oncological patients in palliative care, as well as on the carer. It will be performed using mp3 players or mobile phones.

OTHER

simulation with therapeutic education

Basic therapeutic education repetition performed to all caregivers and oncological patients in palliative care, through earphones

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

  collaborator OTHER

• Andaluz Health Service

  lead OTHER_GOV

Principal Investigators

• Inmaculada Valero Cantero, Nurse · Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud

• Milagrosa Espinar Toledo, Nurse · Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud

• Yolanda Carrión Velasco, Nurse · Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud

• Pilar Castro López, Nurse · Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud

• Milagros Reyes Sánchez, Nurse · Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud

• María Angeles Vázquez Sánchez, Doctor · Universidad de Málaga

• Nuria Garcia-Agua Soler, Doctor · Universidad de Málaga

• Cristina Casals Vázquez, Doctor · University of Cadiz

• Francisco Martínez Valero, Podólogo · Clinica de Podologia

• Ernesto Suárez Cadenas, Doctor · Universidad de Granada

• Librado Valverde, Nurse · Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-09-20

Primary Completion

2021-07-31

Completion

2022-01-31

Countries

• Spain

Study Locations