Complementary Therapy in Home Palliative Care Patients and Their Caregivers. A Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Evaluation of the change of symptoms (at the beginning and at 7 days) using The Edmonton Symptom Evaluation System (ESAS)
研究概览
简要总结
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.
详细描述
Background and status.
Cancer presents an enormous challenge to the world public health. Every year, 8 million people die because of the disease, meaning it´s one of the main causes of death in the world and the pathology changes the patient in all their levels: physical (appearance, treatment consequences), emotional (reactions variability, feelings, distress), cognitive (personality and character, ways of facing the problem and adaptability), social and spiritual. It produces suffering on an individual, familiar and social level.
An estimation of 50-60% of the people that perish in Spain, based on age and death causes, does so after the disease reaches an advanced stage, being terminal. Terminal patients require great amounts of nursing and health care, being these needs very heterogenic and implying both sanitary and social resources.
According to the Andalusian Plan for Palliative Care estimations, Andalusian population susceptible to receive palliative care stands between a minimum of 31.553 and a maximum of 62.887 inhabitants.
World Health Organization (WHO) defined palliative care as: 'An approach that improves the quality of life of patients and their families facing the problem associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual'.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Oncological patients in palliative care at their homes, older than 18 years old, and their formal caregiver, in case they have one.
- •Patients who have given their consent to be included in the study.
排除标准
- •Oncological patients in palliative care at their homes, with diseases in an advanced stage and a short life expectancy (last days).
- •Oncological patients with late stages dementia or psychological pathologies, not being capable of taking conscious decisions.
- •Oncological patients with hypoacusis or profound deafness, hindering the use of the mp3 player or mobile phone.
结局指标
主要结局
Evaluation of the change of symptoms (at the beginning and at 7 days) using The Edmonton Symptom Evaluation System (ESAS)
时间窗: Preintervention/Postintervention (0 and 7 days)
This scale evaluates the average intensity for several symptoms (pain, anxiety, depression, mood and insomnia) in a specific length of time (24 hours, 48 hours, a week) dependant on the patient's condition. The patient will choose the number that better adjust to the intensity of each symptom.
Evaluation of the change in the caregiver's effort index (at the beginning and at 7 days) through The Caregiver Strain Index Questionnaire (CSI)
时间窗: Preintervention/Postintervention ( 0 and 7 days)
Aimed to be answered by the caregiver of dependent people, containing 13 items with True/False answer. Every positive answer scores for 1. If the total is higher or equal to 7 it indicates a high level of strain. Being validated in Spanish, this is the scale used to evaluate the emotional and physical situation of the caregiver regarding their need to take care of a person in palliative care.
Client Satisfaction Questionnaire (CSQ-8)
时间窗: Postintervention (7 days)
8 questions answered through a Likert-type scale of 4 points and self-administered, with specific points to each item. The categories would be as follows: quality of the service, type of services, results and general satisfaction. It will include 3 open questions where the subjects answer what they liked most from the treatment, what they liked less, and what they would change. This tool has been proved to determine patient´s satisfaction with high reliability and coherence, being validated in the 8 items versions for Spanish speakers.
Evaluation of the change in health-related quality of life (at the beginning and at 7 days) through The EORTC. QLQ-30 (The Quality of Life of Cancer Patients).Version 3
时间窗: Preintervention/Postintervention ( 0 and 7 days)
Questionnaire to assess the quality of life of cancer palliative care patients, constituted by 30 items. Items from 1 to 28 correspond to mixed categoric scales from 1 to 4 referring to functional status, physical and emotional symptoms, and the influence of these in the working, social and familial life of the patient. Items 29 and 30 are for the patient to evaluate its general health and quality of life with a 0 to 7 mark.
Evaluation of the change in sleep efficiency (percentage of time in bed sleeping) (at the beginning and at 7 days) by accelerometer
时间窗: Preintervention/Postintervention ( 0 and 7 days)
The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.
Evaluation of the change in the levels of intensity of daily physical activity (at the beginning and at 7 days) by accelerometer
时间窗: Preintervention/Postintervention ( 0 and 7 days)
The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12. When the EPOCHS (5-second sections) have been calculated, periods of different intensity levels are sought (both sedentary lifestyle maintained and intense activities maintained continuously for most of a period of time). With them, variables are created that indicate both sedentary lifestyle and physical activity.
Evaluation of the change in the quality of self-perceived sleep (at the beginning and at 7 days) through The Pittsburgh Sleep Quality Index (PSQI)
时间窗: Preintervention/Postintervention ( 0 and 7 days)
Validated into Spanish. It values the sleep quality perceived by the subject. 7 different scores are obtained from the result, granting information for several components of the sleep quality: subjective quality, sleep latency, sleep duration, sleep efficiency, sleep perturbances (frequency of coughs, snores, heat, cold), sleeping pills intake, diurnal dysfunction (faculty to fall asleep through an activity because of tiredness). The sum of the scores in each component will be included into a Total Score (TS) from 0 to 21. According to Buysse and Cols, a TS of 5 will be the cutting point between a good and a bad sleep quality, less than 5 will show the presence of good sleep quality.
Evaluation of the change in total sleep time and rest time (nighttime sleep and daytime rest / naps) by accelerometer (at the beginning and at 7 days)
时间窗: Preintervention/Postintervention (0 and 7 days)
The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.
Evaluation of the change in sleep interruption (number of awakenings and wakefulness after the onset of sleep) by accelerometer (at the beginning and at 7 days)
时间窗: Preintervention/Postintervention ( 0 and 7 days)
The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.
Evaluation of the change in daytime sleepiness (at the beginning and at 7 days) through the Epworth Sleepiness Scale (ESS)
时间窗: Preintervention/Postintervention ( 0 and 7 days)
Self-administered scale to measure diurnal sleepiness with 8 questions, scoring from 0 to 3 for a maximum score of 24. This scale is validated in Spanish.
Evaluation of the change in the quality of life of the caregiver (at the beginning and at 7 days) through The Quality of Life Family Version (QOL). Dr
时间窗: Preintervention/Postintervention ( 0 and 7 days)
It is an instrument that measures the quality of life of a family member who is caring for a patient in chronic illness, validated to Spanish. It values physical and emotional aspects.
Evaluation of the consumption of health resources at the beginning, at 7 days and per month
时间窗: Preintervention/ Postintervention/per month ( 0 and 7 days and one month after the intervention)
To calculate the expenditure we will analyse the number of Primary Care consultations (family doctor and family nurse), number of home consultations (family doctor, family nurse and case management nurse), number of consultations to the Emergencies service in Primary Care, number of consultations to the hospital Emergencies, and number of hospital admissions (registering number of days). The time used by medical practitioners in phone calls will be also taken into account, from both the Palliative Care Unit and the case management nurse.
Medication consumption evaluation at the beginning, at 7 days and per month
时间窗: Preintervention/ Postintervention/per month ( 0 and 7 days and one month after the intervention)
We will value the medication intake related to analgesics, anxiolytics and sleeping pills.
Availability of payment
时间窗: Postintervention (7 day)
The contingent valuation method will be used to determine the readiness to pay. Patients
Sessions compliance. Assessment question
时间窗: Postintervention (7 day)
Real time dedicated to the activity, for both control and intervention group, will be asked to patients and caregivers during the home visit.
次要结局
- Sociodemographic data from caregivers(Preintervention (0 day))
- Sociodemographic data from palliative care patients(Preintervention (0 day))
研究者
Francisco Javier Navarro Moya
Nurse Degree
Andaluz Health Service