Palliative MedicineMuSt-PCNCT03665168
A Multidimensional Strategy to Improve Quality of Life of Patients With Multiple Symptoms and Palliative Care Needs
An observational study of Palliative Medicine, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
A nationwide, cross-sectional study, to determine the prevalence of symptoms of patients in the palliative phase in various care settings will be performed within a set period of two weeks in September 2018 and two weeks in November 2018. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Palliative Medicine
- How many people
- 659 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2018to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients in various settings will be included (GP practices, home care facilities, general and academic hospitals, hospices) and with any underlying life-limiting disease
Who may be able to join
- Patients of whom the health care professional answers "no" to the question "Would I be surprised if this patient died in the next 12 months ?".
Who cannot join
- •Patients unable or unwilling to self-assess their symptoms
Trial locations and contacts
1 site in 1 country.
About this study
A nationwide, cross-sectional study, to determine the prevalence of symptoms of patients in the palliative phase in various care settings will be performed within a set period of two weeks in September 2018 and two weeks in November 2018. The participating settings will be selected by a total of seven coordinators, one for each consortium of palliative care in the Netherlands. To identify common combinations of symptoms and for multidimensional screening the Utrecht Symptom Diary-4 Dimensional (USD-4D) and Utrecht Symptom Diary (USD), a Dutch instrument based on the Edmonton Symptom Assessment Scale, will be used. The current protocol focuses on the cross-sectional study.
Read the detailed description
The Utrecht Symptom Diary-4 dimensional (USD-4D), a Dutch instrument based on the Edmonton Symptom Assessment Scale, will be used for multidimensional screening and assessment of intensity and prevalence of symptoms. The questionnaire assesses twelve symptoms: pain, sleeping problems, dry mouth, dysphagia, anorexia, constipation, nausea, dyspnoea, fatigue, anxiety, depressed mood and confusion. This is measured on a numeric scale from 0 (no complaints) to 10 (worst imaginable or intolerable).
The prevalence of symptoms will be described by frequencies, dichotomizing symptom scores in absent (0 on NRS) or present (1 or higher on NRS). Symptom scores of 4 or higher on NRS are considered clinically relevant.
There is a possibility to add two more complaints not enlisted and to prioritise the problems which should be addressed first by the HCP.
Quality of life is assessed using a (un)well-being measure and the opportunity to score the experienced value of life.
Finally, five multidimensional questions will screen for mental capacity ("draagkracht"), the relationship with loved ones and thoughts concerning end of life. These multidimensional questions will be filled out together with the HCP. Therefore the HCP decides beforehand whether those questions will be asked.
The USD-4D will be filled out only once by participating patients without follow-up. The patients will be asked to fill out the following characteristics: age, gender, education level, cultural background, living situation, underlying disease, comorbidities, performance score, medication groups and interventions.
The estimated time to fill out both questionnaires is fifteen to twenty-five minutes.
- Conditions
- Palliative Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients in the palliative stage | Adult patients in various settings will be included (General Practioners practices, home care facilities, general and academic hospitals, hospices) and with any underlying life-limiting disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of multiple, simultaneously occurring symptoms
Prevalence of multiple, simultaneously occurring symptoms (symptom clusters) in patients in the palliative phase in Dutch care settings (GP practices, home care facilities, general and academic hospitals, hospices).
Measured: 4 weeks
Secondary outcomes (6)
Prevalence of each separate symptom
For each symptom assessed (pain, sleeping problems, dry mouth, dysphagia, anorexia, constipation, nausea, dyspnoea, fatigue, anxiety, depressed mood and confusion) we will ask patients to score how they feel. In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their experienced intensity of complaints. Zero represents 'no complaint at all' whereas the upper limit represents 'the worst (pain, nausea, etc.) ever possible'.
Measured: 4 weeks
Clinically relevant symptoms
For each symptom assessed (pain, sleeping problems, dry mouth, dysphagia, anorexia, constipation, nausea, dyspnoea, fatigue, anxiety, depressed mood and confusion) we will ask patients to score how they feel. In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their experienced intensity of complaints. Zero represents 'no complaint at all' whereas the upper limit represents 'the worst (pain, nausea, etc.) ever possible'. All scores of 4 and higher are considered clinically relevant.
Measured: 4 weeks
Quality of life (single question with numeric rating scale)
Opportunity to score the experienced quality of life with the question: "how do you feel at this moment?". In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their wellbeing. Zero represents 'feeling very well' whereas the upper limit (10)represents 'feeling very bad'.
Measured: 4 weeks
Symptom burden (multidimensional questions of Utrecht Symptom Diary-4Dimensional)
Five multidimensional theses will screen for mental capacity, the relationship with loved ones and thoughts concerning end of life. The following theses are presented:
- I have the chance to be myself
- I can bear what happens to me
- I can let go of my loved ones
- I am living a balanced life
- Thoughts at the end of life gives me peace of mind
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their experienced feeling. Zero represents 'totally agree' whereas the upper limit represents 'totally disagree'. These values will be descriptive, a higher or lower value is not necessarily a better or worse outcome.
Measured: 4 weeks
Symptoms per care setting
Number of participants with assessed complaints (pain, sleeping problems, dry mouth, dysphagia, anorexia, constipation, nausea, dyspnoea, fatigue, anxiety, depressed mood and confusion) per care setting (general practitioners practices, home care facilities, general and academic hospitals, hospices)
Measured: 4 weeks
Symptoms per underlying disease
Number of participants with assessed complaints (pain, sleeping problems, dry mouth, dysphagia, anorexia, constipation, nausea, dyspnoea, fatigue, anxiety, depressed mood and confusion) per underlying disease (most probably incurable cancer, chronic obstructive pulmonary disease, heart failure and end-stage renal disease).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Sep 2018
- Primary completion1 Sep 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative MedicineStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- An KL Reyners, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665168
- Sponsor's protocol ID
- 201800366
- Acronym
- MuSt-PC
- Status last verified
- Apr 2024
- First submitted
- 7 Sep 2018
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidimensional Strategy to Improve Quality of Life of Patients With Multiple Symptoms and Palliative Care Needs
- ClinicalTrials.gov ID
- NCT03665168
- Acronym / sponsor ID
- MuSt-PC / 201800366
- Conditions
- Palliative Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A nationwide, cross-sectional study, to determine the prevalence of symptoms of patients in the palliative phase in various care settings will be performed within a set period of two weeks in September 2018 and two weeks in November 2018. The participating settings will be selected by a total of seven coordinators, one for each consortium of palliative care in the Netherlands. To identify common combinations of symptoms and for multidimensional screening the Utrecht Symptom Diary-4 Dimensional (USD-4D) and Utrecht Symptom Diary (USD), a Dutch instrument based on the Edmonton Symptom Assessment Scale, will be used. The current protocol focuses on the cross-sectional study.
Detailed description
The Utrecht Symptom Diary-4 dimensional (USD-4D), a Dutch instrument based on the Edmonton Symptom Assessment Scale, will be used for multidimensional screening and assessment of intensity and prevalence of symptoms. The questionnaire assesses twelve symptoms: pain, sleeping problems, dry mouth, dysphagia, anorexia, constipation, nausea, dyspnoea, fatigue, anxiety, depressed mood and confusion. This is measured on a numeric scale from 0 (no complaints) to 10 (worst imaginable or intolerable).
The prevalence of symptoms will be described by frequencies, dichotomizing symptom scores in absent (0 on NRS) or present (1 or higher on NRS). Symptom scores of 4 or higher on NRS are considered clinically relevant.
There is a possibility to add two more complaints not enlisted and to prioritise the problems which should be addressed first by the HCP.
Quality of life is assessed using a (un)well-being measure and the opportunity to score the experienced value of life.
Finally, five multidimensional questions will screen for mental capacity ("draagkracht"), the relationship with loved ones and thoughts concerning end of life. These multidimensional questions will be filled out together with the HCP. Therefore the HCP decides beforehand whether those questions will be asked.
The USD-4D will be filled out only once by participating patients without follow-up. The patients will be asked to fill out the following characteristics: age, gender, education level, cultural background, living situation, underlying disease, comorbidities, performance score, medication groups and interventions.
The estimated time to fill out both questionnaires is fifteen to twenty-five minutes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in the palliative stage | – | –Adult patients in various settings will be included (General Practioners practices, home care facilities, general and academic hospitals, hospices) and with any underlying life-limiting disease. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients in various settings will be included (GP practices, home care facilities, general and academic hospitals, hospices) and with any underlying life-limiting disease
Key inclusion criteria (1 listed)
- Patients of whom the health care professional answers "no" to the question "Would I be surprised if this patient died in the next 12 months ?".
Key exclusion criteria (1 listed)
- •Patients unable or unwilling to self-assess their symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of multiple, simultaneously occurring symptoms
Time frame: 4 weeks
Prevalence of multiple, simultaneously occurring symptoms (symptom clusters) in patients in the palliative phase in Dutch care settings (GP practices, home care facilities, general and academic hospitals, hospices).
6 secondary outcomes
Prevalence of each separate symptom
Time frame: 4 weeks
Clinically relevant symptoms
Time frame: 4 weeks
Quality of life (single question with numeric rating scale)
Time frame: 4 weeks
Symptom burden (multidimensional questions of Utrecht Symptom Diary-4Dimensional)
Time frame: 4 weeks
Symptoms per care setting
Time frame: 4 weeks
Symptoms per underlying disease
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
An KL Reyners, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Medicine, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of multiple, simultaneously occurring symptoms (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.