Palliative CareNCT06107946
The MuSt-PC: a Pilot Study to Assess Symptom Burden of Co-occuring Symptoms
A study testing USD questionnaire in people with Palliative Care, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial summary
In this pilot study, physicians and nurse practitioners working in different care settings will use MuSt-PC, for adult patients with any life-limiting iilness, for whom the Surprise question is answered negatively: if the HCP answers "no" to the question "Would I be surprised if this patiënt died in the next 12… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- USD questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesNetherlands
- Study dates
- 18 Apr 2024to 28 Feb 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients identified as in a palliative care trajectory (based on a negative answer to the surprise question "Would I be surprised if this patiënt died in the next 12 months?")
- All primary diseases (cancer, non-cancer (e.g. COPD, haart failure, frailty)
- Patients should have at least two symptoms on the Utrecht Symptom Diary with a numeric rating score of 4 or higher
- Life expectancy of at least 4 weeks
- Able to fill out Dutch questionnaires
- Informed consent
Who cannot join
- Patients who are unable or unwilling to self-assess their symptoms at baseline.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
University Medical Center Groningen
Groningen
LUMC
Leiden
About this study
Official title: The MuSt-PC: A Multidimensional Strategy to Improve Quality of Life of Patients With Multiple Symptoms and Palliative Care Needs - Pilot Study to Assess the Efficacy of a Clinical Decision Support System
In this pilot study, physicians and nurse practitioners working in different care settings will use MuSt-PC, for adult patients with any life-limiting iilness, for whom the Surprise question is answered negatively: if the HCP answers "no" to the question "Would I be surprised if this patiënt died in the next 12 months?''. In total, at least 20 eligible patients will be recruited and asked to perform all study assessments.
Read the detailed description
In this pilot study, physicians and nurse practitioners working in different care settings will use MuSt-PC, for adult patients with any life-limiting iilness, for whom the Surprise question is answered negatively: if the HCP answers "no" to the question "Would I be surprised if this patiënt died in the next 12 months?''. In total, at least 20 eligible patients will be recruited and asked to perform all study assessments.
After a baseline screening assessment, all eligible patients with at least 2 simultaneously occurring symptoms with a numeric rating score £4 on the 11 point scale on the Utrecht Symptom Diary, will be asked to fiil out the Utrecht Symptom Diary during two weeks.
In the first week twice daily (morning and evening), in the second week once daily (evening).
- Conditions
- Palliative Care
- Being tested
- USD questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USD questionnaireOther
After a baseline screening symptom assessment, all eligible patients with at least 2 simultaneously occurring symptoms with a numeric rating score ≥4 on the 11 point scale on the Utrecht Symptom Diary, will be asked to fill out the Utrecht Symptom Diary during two weeks. In the first week twice daily (morning and evening), in the second week once daily (evening).
| Study group | Role | What they receive |
|---|---|---|
| symptom assessment | Other | Patients will have assessed symptom burden using the Dutch validated ESAS (called USD), build in the MuSt-PC tool. Thereafter, they will record symptom burden in a diary during 2 weeks. Receives: Other: USD questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability and willingness of patients to complete follow-up assessments
the percentage of patients who completed all questionnaires during follow-up
Measured: after 2 weeks
Secondary outcomes (5)
Recruitment of patients; the number of patients that consented and those that declined participation, as well as number of eligible patients.
% of patients
Measured: after 2 weeks
Adherence to advice by patients provided based on the MuSt-PC CDSS
% of patients
Measured: after 2 weeks
Patient impressions of the MuSt-PC CDSS
10 questions with a 4-point Likert scale
Measured: after 2 weeks
Time until symptom burden decreases after the use of the MuSt-PC CDSS based on the filled out Utrecht Symptom Diaries (days)
in days
Measured: after 2 weeks
Feedback about the follow-up assessments within this pilot
open questions
Measured: after 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start18 Apr 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- An KL Reyners, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107946
- Sponsor's protocol ID
- 11087
- Status last verified
- Nov 2025
- First submitted
- 7 Oct 2023
- Last updated
- 25 Nov 2025
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MuSt-PC: A Multidimensional Strategy to Improve Quality of Life of Patients With Multiple Symptoms and Palliative Care Needs - Pilot Study to Assess the Efficacy of a Clinical Decision Support System
- ClinicalTrials.gov ID
- NCT06107946
- Acronym / sponsor ID
- 11087
- Conditions
- Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 30 Oct 2023 (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.
In this pilot study, physicians and nurse practitioners working in different care settings will use MuSt-PC, for adult patients with any life-limiting iilness, for whom the Surprise question is answered negatively: if the HCP answers "no" to the question "Would I be surprised if this patiënt died in the next 12 months?''. In total, at least 20 eligible patients will be recruited and asked to perform all study assessments.
Detailed description
In this pilot study, physicians and nurse practitioners working in different care settings will use MuSt-PC, for adult patients with any life-limiting iilness, for whom the Surprise question is answered negatively: if the HCP answers "no" to the question "Would I be surprised if this patiënt died in the next 12 months?''. In total, at least 20 eligible patients will be recruited and asked to perform all study assessments.
After a baseline screening assessment, all eligible patients with at least 2 simultaneously occurring symptoms with a numeric rating score £4 on the 11 point scale on the Utrecht Symptom Diary, will be asked to fiil out the Utrecht Symptom Diary during two weeks.
In the first week twice daily (morning and evening), in the second week once daily (evening).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| symptom assessment | Other | Other: USD questionnairePatients will have assessed symptom burden using the Dutch validated ESAS (called USD), build in the MuSt-PC tool. Thereafter, they will record symptom burden in a diary during 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients identified as in a palliative care trajectory (based on a negative answer to the surprise question "Would I be surprised if this patiënt died in the next 12 months?")
- All primary diseases (cancer, non-cancer (e.g. COPD, haart failure, frailty)
- Patients should have at least two symptoms on the Utrecht Symptom Diary with a numeric rating score of 4 or higher
- Life expectancy of at least 4 weeks
- Able to fill out Dutch questionnaires
Key exclusion criteria (1 listed)
- Patients who are unable or unwilling to self-assess their symptoms at baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USD questionnaireAfter a baseline screening symptom assessment, all eligible patients with at least 2 simultaneously occurring symptoms with a numeric rating score ≥4 on the 11 point scale on the Utrecht Symptom Diary, will be asked to fill out the Utrecht Symptom Diary during two weeks. In the first week twice daily (morning and evening), in the second week once daily (evening). | Other | symptom assessment |
Primary outcome
Ability and willingness of patients to complete follow-up assessments
Time frame: after 2 weeks
the percentage of patients who completed all questionnaires during follow-up
5 secondary outcomes
Recruitment of patients; the number of patients that consented and those that declined participation, as well as number of eligible patients.
Time frame: after 2 weeks
Adherence to advice by patients provided based on the MuSt-PC CDSS
Time frame: after 2 weeks
Patient impressions of the MuSt-PC CDSS
Time frame: after 2 weeks
Time until symptom burden decreases after the use of the MuSt-PC CDSS based on the filled out Utrecht Symptom Diaries (days)
Time frame: after 2 weeks
Feedback about the follow-up assessments within this pilot
Time frame: after 2 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 25 Nov 2025.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USD questionnaire in people with Palliative Care, run by University Medical Center Groningen at 2 sites 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 6 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 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Ability and willingness of patients to complete follow-up assessments (time frame: after 2 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 25 Nov 2025.