SMEtH - Symptom Management Essentials at Home
Phase: NA
Conditions: Symptom Management
Sponsor: UMC Utrecht

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RESEARCH PROTOCOL (nWMO) 
Effect study 
Template version: 3.0. 
PROTOCOL TITLE ‘SMEtH – Symptom Management Essentials at Home’ 
 
Short title (max 43 characters)  
SMEtH – Symptom Management Essentials at Home 
Version:  
1.0 
Date 
20th December 2022 
Department 
General Practice & Nursing Science 
Coordinating 
investigator/project leader 
 
Dr. E. (Everlien) de Graaf 
UMC Utrecht, div. Julius Centrum 
Huispost Str. 6.131 
PO Box 85500 
3508 GA Utrecht 
The Netherlands 
+31(0)88 75 687 88 
e.degraaf@umcutrecht.nl 
Principal investigator (in Dutch: 
hoofdonderzoeker/ uitvoerder) 
 
Prof. dr. S.C.C.M. (Saskia) Teunissen 
UMC Utrecht, div. Julius Centrum.             
Huispost Str. 6.131 
PO Box 85500 
3508 GA Utrecht 
The Netherlands 
+31(0)88 75 683 96 
+31(0)88 75 681 22  
s.teunissen@umcutrecht.nl 
 
 
 
Other investigator(s) 
Drs. Alexandra Granger  

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UMC Utrecht, div. Julius Centrum 
Huispost Str. 6.131 
PO Box 85500 
3508 GA Utrecht 
The Netherlands 
(+31) (0)63111 8801 
a.granger@umcutrecht.nl 
Sponsor (in Dutch: 
verrichter/opdrachtgever) 
Universitair Medisch Centrum Utrecht (UMCU)  
 
 
Subsidising party 
ZonMw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of content 
1. 
INTRODUCTION AND RATIONALE 
5 
2. 
OBJECTIVES 
6 
3. 
STUDY DESIGN 
7 
4. 
STUDY POPULATION 
8 
4.1 
Population (base) 
8 
4.2 
Inclusion criteria 
8 
4.3 
Exclusion criteria 
9 
4.4 
Sample size calculation 
9 
5. 
METHODS 
10 
5.1 
Study parameters/endpoints 
10 
5.1.1. 
Main study parameter/endpoint 
10 
5.1.2. 
Secondary study parameters/endpoints 
10 
5.1.3. 
Other study parameters 
11 
5.2. 
Study procedures 
11 
5.3. 
Withdrawal of individual subjects 
13 
5.4. 
Replacement of individual subjects after withdrawal 
13 
6. 
STATISTICAL ANALYSIS 
13 
6.1. 
Primary study parameter(s) 
13 
6.2. 
Secondary study parameter(s) 
13 
6.3. 
Other study parameters 
14 
7. 
ETHICAL CONSIDERATIONS 
14 
7.1. 
Regulation statement 
14 
7.2. 
Recruitment and consent 
14 
8. 
ADMINISTRATIVE ASPECTS 
15 
8.1. 
Handling and storage of data and documents 
15 
8.2. 
End of study 
15 
9. 
REFERENCES 
15 
 
 

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LIST OF ABBREVIATIONS AND RELEVANT DEFINITIONS 
 
CCMO  
 
 Central Committee on Research Involving Human Subjects 
(Centrale Commissie Mensgebonden Onderzoek)  
 
Dyspnoea 
 
 
Shortness of breath 
 
General practitioner (GP)  
General Practitioner  
 
Life-limiting illness  
an illness that cannot be cured and from which an individual will 
most likely die 
 
Palliative care (PC) 
PC is care that improves the quality of life of patients and their 
loved ones who are facing a life-threatening condition or frailty, 
by preventing and relieving suffering through early identification, 
assessment, and treatment of problems of a physical, 
psychological, social and spiritual nature.   
 
Quality of life  
 
 An individual’s perception of their position in life in the context 
of culture and value system in which they live and in relation to 
their goals, expectations, standards and concerns 
 
WMO  
 
 Medical Research Involving Human Subjects Act (Wet Medisch-
wetenschappelijk Onderzoek met Mensen)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. INTRODUCTION AND RATIONALE 
The majority of patients with a life-limiting illness experience symptoms, impairing the quality of life(1). 
In 2017, a total of 150.000 individuals died in the Netherlands, of whom the vast majority had cancer 
(41%), cardiac disease (24%) or dementia (16%)(2). The most common experienced symptoms during 
the last phase of life are fatigue, pain, lack of energy, weakness, lack of appetite and dyspnoea(3,4). 
The intensity of these symptoms increases as death approaches, in particular the last two months of 
life(5). To improve the quality of life of patients with a life-limiting illness and family caregivers, 
adequate palliative care (PC) has proven to be essential(6–8). The World Health Organisation (WHO) 
defines PC as “an approach that improves the quality of life of patients (adults and children) and their 
families who are facing problems associated with life-threatening illness. It prevents and relieves 
suffering through the early identification, correct assessment and treatment of pain and other 
problems, whether physical, psychosocial, or spiritual”(9). Multiple studies have shown that PC 
interventions are associated with a lower symptom burden, greater advance care planning, fewer 
hospitalizations, lower healthcare expenses, enhanced communication between healthcare 
professionals and patients, enhanced emotional support, higher patient satisfaction and even 
improved survival(6,10–14). 
 
PC provided by nursing teams working in primary care, is indispensable for 68% of Dutch population 
that prefers to stay at home during the last phase of life. However, merely 36% actually dies at 
home(15,16). The study conducted by Reyniers et al. presents several explanations for inappropriate 
hospitalization near the end of life. Patients were admitted to the hospital when symptom control (55%) 
at home was insufficient according to the patient, family was convinced care was better (54%) at the 
hospital or patients felt safer (35%) at the hospital(17). Nurses play a prominent role in providing PC at 
home, since they are responsible for the detection of signs and symptoms, the performance of 
multidimensional assessments, the collaboration of a wide range of disciplines and the communication 
with patients and their families(18). Additionally, General practitioners (GP) often rely on nurses to 
optimally assess these needs and report this information back. However, previous studies have shown 
multiple barriers in the provision of PC by nursing teams working in homecare organizations, which 
are: the identification of patients with PC needs, the collaboration with GPs and other caregivers, 
knowledge on quality of PC at home and optimizing autonomy, communication, and competences(19). 
As a result, patients with a life-limiting illness suffer concurrently from multiple symptoms that are often 
undetected, impairing the quality of life and making it impossible to stay at home. Family caregivers 
are also known to be susceptible to emotional, social, physical, and financial distress due to the heavy 
duty of taking care of a friend or loved one who is no longer able to care for themselves(20). One in 
ten family caregivers in the Netherlands is overburdened(21). Hence, symptom management in 
patients and family caregivers dealing with a life-limiting illness, living at home in the Netherlands is 
suboptimal.  
 
In order to enhance a systematic approach of PC in primary healthcare, the Palliative Reasoning (PR) 
methodology has been developed(22). This is a stepwise, iterative, multidimensional symptom 
management approach consisting of a preparatory phase, followed by four phases(23,24). 
Multidimensional symptom management plays a central role in this approach and is defined as “the 
treatment of symptoms while taking the physical, psychological, social and spiritual aspect of the 

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problem into account”(25,26). Due to the number of components, the flexibility of the intervention to fit 
different contexts and the effect interaction it has with the context, the implementation is considered to 
be complex. Therefore, the development and implementation strategy of PR is based on the Medical 
Research Council (MRC)-model, figure 1, which is a framework that is commonly used for developing 
and evaluating complex interventions(27).  
Figure 1. The MRC-model(27). 
 
Prior research revealed the need for a systematic symptom management approach and supportive 
tools to support clinical decision making and multidisciplinary collaboration, by homecare nursing 
teams(28). Hence, the feasibility of the PR methodology has recently been tested in primary care. 
However, the effect of this methodology on symptoms of patients remains unknown. To further 
develop, optimize and successfully implement the PR methodology in future primary care practice and 
to improve the quality of life of patients and family caregivers, we aim to determine the effect of the PR 
methodology on the perceived symptoms of patients and family caregivers dealing with a life-limiting 
illness, receiving palliative homecare.  
 
2. OBJECTIVES 
Primary Objective: The primary objective of this study is to determine the effect of the PR 
methodology on perceived symptoms of patients and family caregivers dealing with a life-
limiting illness and receiving palliative nursing care at home by teaching home care nursing 
teams the PR methodology and compare it with usual care provided in the Netherlands.  
 
Secondary objectives:  
- 
To adequately and systematically identify patients with a life-limiting illness in need of 
palliative care by implementing the surprise question in daily practice of nursing 
teams.   
- 
To adequately and systematically identify, analyse and treat symptoms of patients 
and caregivers dealing with a life-limiting illness by implementing the PR 
methodology.   
 

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3. STUDY DESIGN 
To determine the effect of the PR methodology, a pragmatic open-label multicenter cluster 
randomized controlled trial (cRCT) will be conducted in nursing teams working in primary 
care, from January 2024 to March 2026 in Utrecht, the Netherlands. We define a cluster as 
one nursing team in primary care, which is a group of registered nurses (RNs) and nurse 
assistants (NAs) collaborating within one home care organization and within the same district 
with support of specialized nurses (SN) and/or nurse practitioners (NPs). The trial consists of 
an intervention group and a control group. To enhance heterogeneity of usual care in the 
control groups and limit the risk of bias, randomization of the intervention will be conducted 
within one primary healthcare organization.  
 
The intervention starts with the adequate identification of patients in need of palliative care by 
means of the surprise question “would I be surprised if this patient dies in the next year?”. If 
the answer to the question is “no”, the patient is suitable for receiving palliative care. After 
identification the PR methodology is followed by four phases. step 1: map out the individual 
situation, symptom burden and quality of life of the patient, step 2: summarize the current 
problems and develop a proactive policy plan, Step 3: evaluate the effect of the proactive 
policy plan on the symptom burden and quality of life of the patient, step 4: adjust the policy 
plan if necessary and continue evaluating. The Utrecht Symptom Diary – four dimensional 
(USD-4D) will be used to monitor the individual situation, symptom burden and quality of life 
of patients, as described in step 1. This is a Patient Reported Outcome Measure (PROM) 
and is validated in palliative care populations.  
 
The nursing teams selected as control group will continue to provide usual care to patients 
with a life-limiting illness. We define usual care as “care that patients with a life-limiting 
illness, living at home, would be expected to receive as part of normal practice from that 
specific homecare organization”(29). To gain insight into normal practice of the control group, 
we will consult the organization’s current safety standards, guidelines, and protocols. 
Additionally, questions regarding normal practice will be asked during interviews with 
healthcare professionals.  
 
 
 
 

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4. STUDY POPULATION 
4.1 Population (base)  
The study population consists of patients with a life-limiting illness, receiving palliative care 
from nursing teams that work at two large homecare organizations in Utrecht, the 
Netherlands. Patients of different sex and age categories will participate in this study. All 
patients live at home, in the region of Utrecht and suffer from a wide range of life-limiting 
illnesses. Family caregivers participating in this study are the primary caregiver of the patient 
and may live in other regions of the Netherlands than the patient, since they are not bound 
by the range of a homecare organization.  
 
Nursing teams usually consist of nurse assistants (NAs), registered nurses (RNs), 
specialized nurses (SNs) and nurse practitioners (NPs). All types of nurses have different 
educational backgrounds and therefore different job descriptions and responsibilities. NAs 
have three years of practical educational training after receiving their diploma. RN can be 
educated at an intermediate or a higher level. An intermediate RN receives at least 6400 
hours of practical and theoretical education and RN with a higher level of education receives 
at least 6720 hours of education, of which a minimum of 1535 hours of theoretical courses 
and 2300 hours of on-the-job instruction. Both educational programmes take 4 years to 
complete, however, only the higher level of nursing education results in Bachelor of Nursing 
degree. Additionally, both RN can specialize in a certain health field, for example to become 
a district nurse (DN) or oncology nurse, which are SNs. RN with a higher level of nursing 
education can become NPs by completing a Master’s of Advanced Nursing Practice, which 
comprises of 2 additional years of practical and theoretical education(30,31).  
 
4.2 Inclusion criteria 
Patients are eligible if:  
1. patient is 18 years or older. 
2. The patient is diagnosed with a life limiting illness or frailty syndrome with a life 
expectancy of less than a year, estimated by the nursing team, based on the Surprise 
Question.  
3. The patient lives at home.  
4. The patient suffers from at least 1 symptom identified by means of the problem list of 
the Distress Thermometer.  
5. The primary caregiver/informal caregiver is aged over 18 and able to speak and read 
Dutch.  
 
 

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A member of the nursing team is eligible if:  
1. He/she working as a nurse assistant, registered nurse, specialized nurse, nurse 
practitioner or palliative care specialist consultant. 
2. He/she is 18 years or older. 
3. He/she works for at least 16 hours a week. 
 
A nursing team of a participating homecare organizations is eligible if: 
1. The nurses that are part of the nursing team are motivated to participate in the study. 
2. The Nursing team has a total of ten or more patients under their care suffering from a 
life-limiting illness.  
 
Chaplains, GPs, paramedics, social workers, and other healthcare professionals are eligible 
if:  
1. He/she is 18 years or older. 
2. He/she actively collaborates with one of the included nursing teams. 
 
4.3 Exclusion criteria 
Patients diagnosed with cognitive impairment and/or patients unable to read and speak 
Dutch, will be excluded from the study.  
4.4 Sample size calculation 
As concluded by Adams et al., there is always a certain degree of uncertainty in estimating 
the magnitude of the intraclass correlation coefficient (ICC) for cRCTs beforehand(32). 
Therefore, the following calculation aims to provide the most accurate estimate of the 
required sample size, in order to demonstrate an effect. Based on our experience required 
during KWASA, a pilot study, primary nursing teams identify on average twenty patients with 
a life expectancy of one year or less. Hence, we expect the inclusion of twenty patients per 
nursing team to be feasible during this study. To estimate the number of clusters as accurate 
as possible, we considered different ICCs and different effect sizes for the intervention 
group(I). We calculated the number of clusters necessary assuming a power of 80%, an 
alpha of 5%, an effect size of 30% in the control group (C) and an effect size of 40% and 
60% in the intervention group. Table 1 shows an overview of the results of our calculations.  
 
Table 1. Overview results sample size calculation with different ICC and effect size. 
ICC 
N patients 
I 
C 
N clusters 
0.02 
20 
0.4 
0.3 
26 
0.01 
20 
0.4 
0.3 
23 
0.005 
20 
0.4 
0.3 
21 
0.001 
20 
0.4 
0.3 
20 
0.02 
20 
0.6 
0.3 
5 
0.01 
20 
0.6 
0.3 
4 
0.005 
20 
0.6 
0.3 
4 
0.001 
20 
0.6 
0.3 
4 

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* ICC = Intraclass correlation coefficient. N patients = Number of patients in the cluster.  
I = Intervention group. C = Control group. N cluster = Number of clusters. 
 
According to our calculation a total of 20 clusters in each arm is the best fit for this study, 
assuming an effect size of 40% and an ICC of 0.001. A higher ICC results in a limited 
number of extra clusters, therefore, a total of 800 patients divided into 40 clusters is in our 
opinion the most appropriate. All calculations have been conducted with help of a 
methodologist from the Julius Centre and by means of the ClusterPower package of RStudio 
(Vienna, Austria), version 2022.12.0+353.  
 
 
5.  METHODS 
5.1 Study parameters/endpoints 
5.1.1. Main study parameter/endpoint 
The main study parameter is “perceived symptom control of patients and family caregivers 
dealing with a life-limiting illness, after one month of implementing the SMEtH-intervention”. 
Perceived symptom control is defined as the perception of symptom control by a patient, 
assessed at enrolment and after one month by a one item question: “Do you feel your 
symptoms are under control? Yes/ No?”. The endpoint of one month has been chosen to 
limit the number of missing data due to death of participating patients.  
5.1.2. Secondary study parameters/endpoints 
The Quality of life of patients is assessed at enrolment, at one, three and six months by 
means of the EORTC QLQ C15 pal(33). This is a 15-item questionnaire developed by the 
European Organisation for research and treatment of cancer Quality of Life Group. The 
questions are answered on a scale from 1 to 4, in which the number 1 refers to “not at all”, 2 
refers to “a little”, 3 refers to “quite a bit” and 4 refers to “very much”. The EORTC QLQ C15 
pal is a shorted version of the original EORTC QLQ C30 pal, which is specifically developed 
for palliative care. To optimize the feasibility of measures, this shortened version will be used 
to reduce the risk of missing items and decrease the burden on participating patients.  
 
Symptom burden of patients is assessed at enrolment, at one, three and six months by 
means of the Utrecht Symptom Diary Four Dimensional (USD4D), which is a patient reported 
outcome measure (PROM)(34). The USD4D comprises of questions regarding the physical, 
psychological, social, and spiritual dimension, which are rated on a scale from 0-10 (0 = 
symptom is absent to 10 = severity symptom is the worst imaginable).  
 
Primary caregiver burden is defined as the perceived burden of the individual that is faced 
with the primary responsibility of taking care of a disabled friend or loved one. The primary 
caregiver burden Is assessed at enrolment, one, three and six months by means of the Self 
Rated Burden Scale, which is a one item numerical scale answering the question “How do I 
perceive the care for my loved one at the moment?”(35–38). The question is answered on a 
scale of 0 to 10, in which 0 refers to “not at all straining” and 1 refers to “much to straining”. In 

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addition, the perceived burden of informal care (Dutch: Ervaren Druk Informele Zorg (EDIZ)) 
will be used, assessing aspects of informal care contributing to the perceived burden(39). 
The EDIZ is developed for the use in caregivers of patients suffering from dementia at home, 
however, this measurement instrument is widely used to assess the level of burden of 
caregivers of patients with a life-limiting illness. This instrument contains 9 statements to 
which patients must answer “no!”, “no”, “more or less”, “yes” or “yes!”.  
 
Current symptom management practices, roles and responsibilities, collaboration, 
communication, and competences are assessed by means of a questionnaire for all 
participating nurses and GPs at enrolment and after six months.  
5.1.3. Other study parameters 
The following demographic characteristics will be collected of all participating parties:  
- 
Patient demographics: age, gender, marital status, education level, employment 
status (retired, unemployed, employed), (past) illness, type of employment (in the 
past), duration of illness, treatment, phase of illness, comorbidity, performance status 
(KPS), time under nursing care, number of visits per day/week. These demographics 
will be collected by means of a questionnaire at baseline.  
- 
Primary caregiver demographics: age, gender, education level, role, employment 
status assessed at enrolment. These demographics will be collected by means of a 
questionnaire, at baseline, three, six and twelve months after enrolment.   
- 
Nurse demographics participating in individual assessments: age, gender, education 
level, employment status (fulltime/parttime), duration of current employment at 
enrolment. These demographics will be collected by means of a questionnaire, at 
baseline, six and twelve months after enrolment.   
- 
GP demographics: age, gender, employment status (fulltime/parttime), duration of 
current employment at enrolment. These demographics will be collected by means of 
a questionnaire, at baseline.    
- 
Nursing team demographics: education level, local collaborations with GP and 
paramedics, symptom management practices at enrolment. These demographics will 
be collected by means of a questionnaire, at baseline, six and twelve months after 
enrolment.   
The demographics mentioned above will also be used during the process evaluation that is 
part of phase four of this study.   
5.2. 
Study procedures 
Firstly, this study will start with the assessment of team characteristics, to develop a suited 
implementation strategy that fits the team and local context but does not influence the fidelity 
of function. Depending on the composition of the team, education levels and competences in 
the team, education and training content will be established by a team of coaching experts, 

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consisting of independent NPs and GPs with extensive experience in PC and PR. The 
intervention group will be educated in identifying patients with PC needs and will be taught 
how to apply PR in a four-day training with practical assignments. After two weeks of 
providing this four-day training to the nursing team, team coaches will be coached by means 
of a coaching on the job trajectory once a fortnight by the team of expert coaches. Team 
coaches that will be trained work as NP or SN within one of the organizations and are 
teamed up with RNs of the general nursing team. The team coaches will perform day to day 
coaching on the job. The implementation of the intervention will take approximately one 
month and will be planned in collaboration with the teams and the coaches.                                                    
Additionally, nurses who are enrolled in the study will be invited to complete questionnaires 
individually at enrolment and at six months about their own current symptom management 
practices, roles and responsibilities, collaboration, communication, and competences.  
 
Secondly, the research team will perform an assessment of baseline measurements in 
participating patients and request to complete a questionnaire regarding demographic 
characteristics. The assessment of baseline measurements will be performed by post, mail, 
telephone, or teleconsulting depending on what is the most suitable and least burdensome 
for the patient. Subsequently, patients will complete at one-, three- and six-months a 
questionnaire containing questions regarding symptom control, quality of life and symptom 
burden. If these questionnaire reveals that a patient does not suffer from any symptoms, it 
will be excluded from the study. However, the excluded patients will be asked to complete 
the Lastmeter questionnaire to detect symptoms that may develop at a later stage, to be able 
to reconsider their inclusion in the study. After each questionnaire and/or assessment 
patients will be offered support of a NP, specialised in PC to talk about possible thoughts or 
concerns raised by completing the questionnaires.  
 
Lastly, an assessment of demographic characteristics and perceived care burden on the 
primary caregiver is performed by the research team. Thereafter, at one-, three- and six-
months perceived care burden is evaluated by telephone using the EDIZ rating scale. After 
each assessment the primary caregiver will be offered support of a NP, specialised in PC to 
talk about possible thoughts or concerns raised by completing the questionnaires. 
 
Blinding:  
In causal studies, blinding is performed ideally at participant, data collection and data 
analysis level. In this case, however, blinding at the analysis level is the only feasible.  
- 
The participants are not blinded. Patients, primary caregivers, and the nursing teams 
will all be aware of their allocation to the intervention group, since the method 
Palliative Reasoning will be implemented in daily care.  
- 
The data collection will not be performed blindly. Firstly, the data are collected by 
local nurses who are aware of their allocation. Secondly, the research team who is 
involved in training the participants are also aware of the allocation, which is 
necessary to ensure an in-depth exploration of the experiences of the nursing team 

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during the up-following qualitative part of this study. This part will be described in a 
different research protocol, which is part of phase 4 of this study.  
- 
Data analysis will be performed blinded. The researcher performing the data analysis 
will be blinded for the group allocation using labels. The labels will be opened after 
the analysis.  
 
Randomization and allocation:  
The clusters will be randomized through a simple randomization method with the Clinical 
Trial Randomization Tool from the National Cancer Institute(40,41). To minimize the risk of 
allocation bias, we will stratify between both homecare organization. The teams are informed 
about their allocation by the research team. 
 
5.3. 
Withdrawal of individual subjects 
Patients and caregivers will be informed that consent may be withdrawn at any stage of the 
study, without stating a reason or any consequences.   
5.4. 
Replacement of individual subjects after withdrawal 
After the withdrawal of a patient, the patient will specifically be asked if the collected data up 
to that point may be used for the purposes of this study. If not, data regarding this patient will 
be removed from the database.  
 
6. 
STATISTICAL ANALYSIS 
6.1. 
Primary study parameter(s) 
To determine the effect of the SMEtH-intervention on the perceived symptom control after 1 
month of patients of each nursing team, a mixed effects logistic regression analysis will be 
conducted. We will control for the following baseline measurements: age, gender, primary 
diagnosis, and performance status. Missing data are imputed using multiple imputation 
(MICE package in R) or if necessary, Bayesian imputation and analysis (Joint AI package in 
R). The quantitative data will be presented as odds ratio and 95% confidence interval (CI) in 
tables and graphs for the visualization of the results. Additionally, all analyses of primary and 
secondary study parameters are conducted by means of the statistical program RStudio, 
version 2022.12.0+353. (Vienna, Austria), and are considered statistically significant if α ≤ 
0.05. 
6.2. 
Secondary study parameter(s)  
Primary caregiver burden, symptom burden and quality of life of patients will be analyzed 
longitudinally using joint models for longitudinal analyses per symptom. Due to the fragility of 
the population, censoring of data will increase over time. Therefore, we will control for death, 
as well as age, gender, primary diagnosis, and performance status. Additionally, subgroup 
analyses for gender, age and primary diagnosis will be conducted for each secondary study 
parameter. 

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6.3. 
Other study parameters 
To provide characteristics of patients, primary caregivers, individual nurses, nursing teams 
and GPs at baseline, descriptive statistics will be used and displayed in tables.  
 
7. 
ETHICAL CONSIDERATIONS 
7.1. 
Regulation statement 
This study will be performed according to GDPR (AVG), WGBO and code of conduct.  
 
The risk of adverse health effects if patients participate is low since the intervention focuses 
on the methodological application of nursing essential care symptom management. In other 
words, it does not impose specific interventions to each participant, it rather is a systematic 
approach and deployment of current guidelines in palliative care.  
As sign of gratitude for participating in the study and to ensure uniformity of practice within 
both healthcare organizations, all control groups will be offered the intervention after 
completing the study.  
7.2. 
Recruitment and consent 
Recruitment and consent of participants takes place on multiple levels:  
Home care organizations will be recruited from a convenience sample of existing cooperation 
partners of the University Medical Centre Utrecht and from interested home care 
organizations. Contact with the organizations will take place through mail and telephone. If 
directors of the organizations consent to participation, regional and team managers will be 
contacted for further information. Information regarding this study will be provided digitally 
and verbally, however, the local routing of consent can alter per organization depending on 
the structures of the organization.  
 
After consent of the home care organizations, team managers will receive written information 
about the study and if a team is interested, an information session will be organized to 
provide detailed information. During and after the information session, nursing teams will 
have the opportunity to ask questions that arise from the provided information. Verbal and 
oral consent for participation of a nursing team will be given by each team manager of the 
corresponding team.  
 
The attending nurse and a contact person of each nursing team will screen patients on 
eligibility, to ensure a structured patient selection. During the study period the cohort will be 
accessible for the enrolment of new patients that meet the inclusion criteria. Eligible patients 
will be approached and asked by the attending nurse to participate. In case of a positive 
response, the nurse will ask the patient for permission to share their contact details with the 
research team to receive further information regarding the study. Patients will receive oral 
and written information and detailed participant information forms. The need for additional 
information or questions arising from the provided information will be answered by the 

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researchers in person or by telephone. After obtaining the written informed consent of the 
patient and the primary caregiver, both will be enrolled in the study. In case of unwillingness 
to participate in the study by a family caregiver, a patient still can be enrolled if desired.   
 
8. 
ADMINISTRATIVE ASPECTS  
8.1. 
Handling and storage of data and documents 
Castor will be used to collect and store the data. Data are pseudonymized by coding. A local 
key will be stored on location and an overall key will be stored separately from the data on a 
privacy server, according to the data management guidelines of the Julius Centre. All 
documents will be stored in the study server of the Julius Centre. Further information can be 
found in the Data Management Plan (DMP).  
8.2. 
End of study 
This investigation is scheduled to end in March 2026.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9. 
REFERENCES 
1. World Health Organization. Palliative care [Internet]. 2020 [cited 2023 Nov 28]. Available 
from: https://www.who.int/news-room/fact-sheets/detail/palliative-care 

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2. Oosterveld-Vlug MG, Heins MJ, Boddaert MSA, Engels Y, Heide A van der, Onwuteaka-
Philipsen BD, et al. Evaluating quality of care at the end of life and setting best 
practice performance standards: a population-based observational study using linked 
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