The MuSt-PC: a Pilot Study to Assess Symptom Burden of Co-occuring Symptoms

NCT06107946 | Completed

• 1 other identifier: 11087
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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 months?''. In total, at least 20 eligible patients will be recruited and asked to perform all study assessments.

Conditions

Palliative Care

Outcome Measures

Primary Outcomes (1)

• Ability and willingness of patients to complete follow-up assessments

  the percentage of patients who completed all questionnaires during follow-up

  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.

  after 2 weeks

• Adherence to advice by patients provided based on the MuSt-PC CDSS

  after 2 weeks

• Patient impressions of the MuSt-PC CDSS

  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)

  after 2 weeks

• Feedback about the follow-up assessments within this pilot

  after 2 weeks

Study Arms (1)

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.

Other: USD questionnaire

Interventions

USD questionnaire OTHER

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).

symptom assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who are unable or unwilling to self-assess their symptoms at baseline.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Leiden University Medical Center: collaborator

Study Sites (2)

University Medical Center Groningen

Groningen, Netherlands

Location

LUMC

Leiden, Netherlands

Location

Study Officials

• An KL Reyners, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: October 30, 2023
• Study Start: April 18, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

NL (2)