Clinical trial NCT03665168: A Multidimensional Strategy to Improve Quality of Life of Patients With Multiple Symptoms and Palliative Care Needs
Official title: A Multidimensional Strategy to Improve Quality of Life of Patients With Multiple Symptoms and Palliative Care Needs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Palliative Medicine
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 659
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

Eligibility criteria: Patient selection will be performed by health care providers in the participating settings.

Inclusion Criterium:

• 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 ?".

Exclusion Criterium:

•Patients unable or unwilling to self-assess their symptoms

Primary outcomes:
measure: Prevalence of multiple, simultaneously occurring symptoms
timeFrame: 4 weeks
Secondary outcomes:
measure: Prevalence of each separate symptom
timeFrame: 4 weeks
measure: Clinically relevant symptoms
timeFrame: 4 weeks
measure: Quality of life (single question with numeric rating scale)
timeFrame: 4 weeks
measure: Symptom burden (multidimensional questions of Utrecht Symptom Diary-4Dimensional)
timeFrame: 4 weeks
measure: Symptoms per care setting
timeFrame: 4 weeks
measure: Symptoms per underlying disease
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: An KL Reyners, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: