Palliative Care Clinical Trial
Official title:
Complementary Therapy in Home Palliative Care Patients and Their Caregivers. A Clinical Trial
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.
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'.
A revision carried out in 2011 by the World Federation of Music Therapy (WFMT) defined music
therapy as 'The professional use of music and its elements as an intervention in medical,
educational, and everyday environments with individuals, groups, families, or communities who
seek to optimize their quality of life and improve their physical, social, communicative,
emotional, intellectual, and spiritual health and wellbeing'.
Integrating music therapy into palliative care intervention could help patients and
caregivers to deal with some of the physical, emotional, social and spiritual needs they
face: making changes in pain and anxiety perception easier, improving the mood, relaxing,
enabling better emotional expressions, connecting with spirituality and offering support
during mourning.
To perform adequate care services at home, a main caregiver is needed to guarantee that
patients have all their basic needs cover, follow the scheduled treatment for the symptoms,
get continuous family and social support and attention, specially at the end. But the
caregiver's health can be affected, specially if subjected to an overload of work or
adaptation to rapid changes in the person taken care of, affecting its quality of life.
For the most optimal performance of the caregiver, it is needed that they are also
recognised. A systematic review in 2008 showed a lack of evidence-based interventions that
support attention given to the caregivers of cancer patients, encouraging nurses to keep
researching and putting to test intervention that reduce the burden on caregivers. However,
several interventions in the attention to caregivers of terminal or palliative care patients
proves their efficacy. Regarding the use of music therapy to achieve an improvement on the
caregiver wellbeing, very few studies can be found.
Bibliography offers more and more studies and systematic reviews regarding music therapy in
the intervention of cancer patients under palliative care, where the main goal is the study
of the music therapy as a complementary treatment and a no-pharmacological treatment of
anxiety, depression, pain, quality of life and physiological symptoms, pointing to its
efficacy.
Kordovan et al. (2016) performed a prospective review of viability, acceptance and possible
beneficial effects of music therapy in hospitalised terminal cancer patients, and the authors
summarised that music therapy, especially receptive methods, are feasible and well regarded
among these patients. A controlled randomised trial performed with hospitalised palliative
care patients revealed music therapy to be an effective treatment to promote relaxation and
wellbeing for the patients. The music therapy didn't differ from the control treatment in
terms of pain reduction, but it was significantly different in the fatigue aspect of quality
of life scale , being considerably lower. Control treatment was verbal relaxation.
On economic aspects, Keenan A., Keithley JK. (2015) made an integrating review about music
effect in adults' cancer pain, stating a limited evidence of music therapy in pain treatment.
Integrative methods using music may represent an important intervention that nurses can
suggest as an economical, non-toxic and easily available to potentially reduce cancer pain.
Efficiency wise, several publications point to a reduction in expenses mainly due to a lower
medication intake, and it may as well mean a reduced number of professional attention and
hours dedicated to deal with the symptoms.
Another systematic review by Qi He Mable L., Drury VB., Hong PW. (2010) showed the
development of two important finding: music therapy can and must be used in palliative
environments to promote social interaction and communication with family, friends, other
patients and health practitioners; and it may as well be used to provide support to patients'
needs. Through music therapy, patients noticed an improvement on social interaction and
communication with their surroundings and a better way to satisfy their physical,
psychological and spiritual needs.
In a Cochrane review from Bradt et al. (2016), authors concluded that music intervention can
bring positive results on anxiety, pain, mood and quality of life in cancer patients, but the
results must be read with caution as the bias risk is high.
In a study carried out by Gallager et al. (2017), it was proposed to understand the insight
of family members regarding music therapy undertaken by the palliative care patients. Out of
50 participants, 82% indicated an improvement for both the relative and the patient in stress
management, mood and quality of life, the session being rated as extremely useful in the 80%
of cases, and 100% of them recommended more sessions. Patients reported a statistically
significant improve regarding pain, depression, distress and mood. The study concludes that
palliative patients´ relatives inform of an improvement on both patients and relatives, but
more research is needed to fully comprehend the beneficial effects on the family.
This study proposes using music therapy on both patients and caregivers, differing in the way
of choosing the music. Whereas most studies in the bibliography resort to picking relaxing
music among different categories, such as jazz, folk or country, we aim to ask the
participants to choose the music the want to listen to. This study will consider that the
same genre can vary in the options available for the patients, triggering different emotions
in different people depending on personal experiences. Although people can distinguish
between sad and cheerful tunes, most people have preferred music that cheer us up or saddens
us and we use it to our convenience, so the study will focus on the music that makes each
patient feel better, assuming than that is the key to achieve better results.
This clinical trial will consider all recommendations from the authors of the Cochrane 2016
review to avoid bias.
Despite the high potential benefit that it could be to optimise medication intake and reduce
sanitary resources expenditure, the evidence on cost-effectiveness in music intervention is
very limited, so this study will also try to determine the efficiency of the intervention.
Economic evaluation methods will be applied, along with a helping tool to determine, through
decisions taken, the optimal use of sanitary resources and allowing the gathering of feedback
of the impact of the intervention for both the organisation and the social program.
General objective:
- To evaluate the efficacy and cost-effectiveness of a music intervention program applied as
a complementary treatment on palliative care for oncological patients and caregiver in a
domestic environment, compared to standard treatment.
Specific objectives:
- To assess if the oncological patients in palliative care included in the intervention
group present significant differences with the control group regarding: pain, anxiety,
depression, mood and insomnia.
- To evaluate if the oncological patients in palliative care included in the intervention
group present significant differences with the control group in their quality of life.
- To assess if the caregivers of the intervention group patients present significant
differences with those of the control group regarding the Caregiver Burden Scale and
quality of life.
- To value caregivers and patients' satisfaction with the intervention.
- To estimate the sanitary cost associated to the music intervention program compared to
traditional sanitary interventions.
Methodology:
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 included into the Assistance Procedure of
Palliative Care in digital health history (DIRAYA) and their unofficial caregivers.
- Subjects acquisition will be performed randomly through a phone list obtained using the
program Epidat 3.1, taking the required number of palliative care patients, contacting
each of them and evaluating if inclusion criteria are met, offering the chance of taking
part of the intervention and handing over the correspondent information document. In
case the patient accepts, a consent form must be signed. In case the patient has an
unofficial caregiver, they will be offered to take part in the study as well, giving
them the information sheet and signing the consent form specific for the caregiver in
case they accept.
- The randomisation mechanism that has been chosen is as follows: letters will be ready
with 'you have been included in the intervention group' and 'you have been included in
the control group' in a number that meet the requirements, they will be put into opaque
envelopes, shuffled and numbered. Participants will be assigned a participation number
and the researcher in charge of randomisation will pick and open the envelope assigned
to the participant number. This system ensures the number is fixed for each group and
prevents tampering.
The palliative care patient and the caregiver are offered to participate and, if both accept,
they will be offered an envelope that will be valid for both, taking part into the study in
the same group. If only one of the two accepts, they will be offered an envelope as well.
Participants will be taken until the desired number of cases is reached.
Once the researcher in charge of randomisation knows which groups the patient and the
caregiver belong to according to the envelope, they will be informed of the procedure they
will undergo without knowing their belonging to either the control or the intervention group.
• Sample size: the most relevant variable to be considered is anxiety for palliative care
patients. In Bradt et al. (2016) revision it was presented with a standard deviation of 1'8
in a similar sample using a scale with a wider range than the one used in this study.
Previous bibliography shows significant differences after music intervention, with a specific
estimation of difference in 7 (29% of standard deviation). A research using the Edmonton
Scale (in oncological patients, treatments with ginseng) showed a value of 0-83 points with a
standard deviation of 2.34 (35% of standard deviation). If we consider as clinically relevant
a decrease of 2 points in the anxiety before-after, expecting a standard deviation of at most
2.5 in our population; with an alpha error of 0.05 and a beta of 0.10 2 samples of 33
subjects are needed, choosing the ration for the samples in 1:1. A 20% increase, making it 2
samples of 40 subjects, would be desirable to avoid patients loss/dropping the intervention.
According to Hanser et al. (2011), there is an increase in the caregivers´ satisfaction with
the music therapy, with a standard deviation of 1.33 on relaxation, 1.87 on comfort, and 1.23
in happiness. If we take a 1-point increase in caregivers' happiness as relevant, 2 samples
of 34 carers would be needed. A 20% increase, making it 2 samples of 41 subjects would be
desirable to avoid subjects loss/dropping the intervention.
- Procedures by group
- Control group: the regular treatment will be carried out according to the
Andalusian Plan of Palliative Care of the Health Counsel, following the standards
and recommendations from the Minister of Health and Social Policy Palliative Care
Units. It will consist on a complete initial valuation of the palliative care
patient and the caregiver using Virginia Henderson's 14 fundamental needs (Need
Theory) and the subsequent treatment and follow-up care plan for problems and
symptoms detected; a therapeutic education about eating and hydration, lessons
about exercise and leisure, medication, effective communication, skin care,
prevention and treatment of constipation, and sleep hygiene will be also carried
out. These patients and caregivers will receive the basic therapeutic education in
a mp3 player or mobile phone (audio document shared on Drive) to be repeated and
listened to in daily sessions of 30 minutes for 7 days. This way, the patients
won´t know the group they are included in, and the nurses managing and evaluation
the patients will also be blind.
- Intervention group: subjects will receive conventional health assistance,
complemented by music therapy activity consisting in pre-recorded preferred music,
for both patients and caregivers. Music will be chosen among the one that make each
of the subjects feel good. It will be reproduced through an mp3 player or mobile
phone (using the Premium Spotify program) in daily sessions of 30 minutes for 7
days.
- To evaluate the expected objectives, valuations by means of home visits will be made,
both preintervention and a week after the start of the intervention, for both groups. A
home visit will also be done after a month to assess economic parameters.
- The following valuation scales will be used: Edmonton Scale, Symptoms Assessment System,
EORTC QLQ-C30, Caregiver Burden Scale, Pittsburgh Sleep Quality Index, Epworth
Sleepiness Scale (ESS), The Quality of Life Family Version, Client Satisfaction
Questionnaire, and Economic valuation.
- Statistical analysis: a descriptive study of the collected factors will be carried out
by means of media and standard deviation for normal continuous variables; calculating
confidence interval for punctual estimations; through median and interquartile range in
not normal continuous variables; and frequencies and percentages in categoric variables.
Adjustment to normality will be determined by the Shapiro-Wilk test. The basal values of
both groups 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, where the
dependant variables will be: pain, anxiety, depression, mood, insomnia and quality of
life; the independent variables will include intervention, sociodemographic (sex, age,
studies, civil status) and clinical (pathology, palliative care time) variables of the
subjects. The economic valuation will be a cost-effectiveness analysis, following the
recommendations proposed in the guide to evaluate economic performances in health
technologies. For each group, we will measure the cost, incremental cost, AVAC
effectiveness, incremental effectiveness, dominance and, in case there is no dominance,
results will be showed as an incremental cost-effectiveness ratio. To assess the costs,
direct sanitary costs and intervention related costs will be considered. Sanitary
resources costs will be estimated using the public prices set by the SSPA58. The cost of
direct resources used during the intervention will be estimated by means of their
recommended retail price (RRP). To calculate the AVAC, the EuroQol-5D-5L Questionnaire
will be used. Uncertainty variables analysis will be subject to univariant and
polyvariant sensitivity analysis.
In the event of finding statistically significant data in normal variables, the confidence
range will be calculated on 95%, allowing the estimation of values where the difference is
found. SPSS 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.
• This study is in agreement with the current ethic recommendations:
- Principles of the Declaration of Helsinki (1975) reviewed in 2013 (AMM), ethical
principles for researching in human, adopted by the 64th Genera Assembly, Fortaleza,
Brazil, October 2013).
- All personal data and information obtained in this study are confidential and will be
deal with in accordance to the EU regulation 2016/679 of the European Parliamentary
Group and the Council on April 27th of 2016 for General Data Protection Regulation
(GDPR).
- Law 41/2002 from November 14th, basic regulation law for patient´s autonomy, obligations
and rights regarding information and clinical documentation. Participation will be
voluntary, and a written consent form must be signed to be included in the study.
Patients and caregivers will be treated with maximum respect, without economic,
religious, ethnic or sexual orientation discrimination. All participants will be
informed both oral and written about the content and characteristics of the study,
remarking the voluntary character and the possibility of rejecting taking part in the
study, or dropping from it in any moment if it is desired. All data obtained will be
private and confidential, its use reserved only for the purposes of this study and being
destroyed afterwards.
The investigation Project hast been accepted by the Ethic Committee for Provincial Research
in Malaga. During the study, the Code of Good Scientific Practice will be upheld.
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