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

Not Applicable

Recruiting

• Conditions: Palliative Care
• Interventions: Other: USD questionnaire

• Registration Number: NCT06107946
• Lead Sponsor: University Medical Center Groningen

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.

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 Timeline

• Study First Submitted: 2023-10-07
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-30
• Study Start: 2024-04-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
symptom assessment	USD questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Ability and willingness of patients to complete follow-up assessments	after 2 weeks	the percentage of patients who completed all questionnaires during follow-up

Secondary Outcome Measures

Name	Time	Method
Recruitment of patients; the number of patients that consented and those that declined participation, as well as number of eligible patients.	after 2 weeks	% of patients
Feedback about the follow-up assessments within this pilot	after 2 weeks	open questions
Adherence to advice by patients provided based on the MuSt-PC CDSS	after 2 weeks	% of patients
Patient impressions of the MuSt-PC CDSS	after 2 weeks	10 questions with a 4-point Likert scale
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	in days

Trial Locations

Locations (2)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

LUMC; 🇳🇱 Leiden, Netherlands