Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-17 @ 10:05 AM
Study NCT ID:
NCT03665168
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2018-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multidimensional Strategy to Improve Quality of Life of Patients With Multiple Symptoms and Palliative Care Needs
Sponsor:
University Medical Center Groningen
Organization:
Study Overview
Official Title:
A Multidimensional Strategy to Improve Quality of Life of Patients With Multiple Symptoms and Palliative Care Needs
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MuSt-PC
Brief 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. 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: