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Completed

NCT Number: NCT03665168

A Multidimensional Strategy to Improve Quality of Life of Patients With Multiple Symptoms and Palliative Care Needs

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.

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Key information

Conditions

Palliative Medicine

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of multiple, simultaneously occurring symptoms

    Time frame: 4 weeks

    Prevalence of multiple, simultaneously occurring symptoms (symptom clusters) in patients in the palliative phase in Dutch care settings (GP practices, home care facilities, general and academic hospitals, hospices).

Secondary outcomes

  1. Prevalence of each separate symptom

    Time frame: 4 weeks

    For each symptom assessed (pain, sleeping problems, dry mouth, dysphagia, anorexia, constipation, nausea, dyspnoea, fatigue, anxiety, depressed mood and confusion) we will ask patients to score how they feel. In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their experienced intensity of complaints. Zero represents 'no complaint at all' whereas the upper limit represents 'the worst (pain, nausea, etc.) ever possible'.

  2. Clinically relevant symptoms

    Time frame: 4 weeks

    For each symptom assessed (pain, sleeping problems, dry mouth, dysphagia, anorexia, constipation, nausea, dyspnoea, fatigue, anxiety, depressed mood and confusion) we will ask patients to score how they feel. In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their experienced intensity of complaints. Zero represents 'no complaint at all' whereas the upper limit represents 'the worst (pain, nausea, etc.) ever possible'. All scores of 4 and higher are considered clinically relevant.

  3. Quality of life (single question with numeric rating scale)

    Time frame: 4 weeks

    Opportunity to score the experienced quality of life with the question: "how do you feel at this moment?". In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their wellbeing. Zero represents 'feeling very well' whereas the upper limit (10)represents 'feeling very bad'.

  4. Symptom burden (multidimensional questions of Utrecht Symptom Diary-4Dimensional)

    Time frame: 4 weeks

    Five multidimensional theses will screen for mental capacity, the relationship with loved ones and thoughts concerning end of life. The following theses are presented:

    • I have the chance to be myself
    • I can bear what happens to me
    • I can let go of my loved ones
    • I am living a balanced life
    • Thoughts at the end of life gives me peace of mind

    In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their experienced feeling. Zero represents 'totally agree' whereas the upper limit represents 'totally disagree'. These values will be descriptive, a higher or lower value is not necessarily a better or worse outcome.

  5. Symptoms per care setting

    Time frame: 4 weeks

    Number of participants with assessed complaints (pain, sleeping problems, dry mouth, dysphagia, anorexia, constipation, nausea, dyspnoea, fatigue, anxiety, depressed mood and confusion) per care setting (general practitioners practices, home care facilities, general and academic hospitals, hospices)

  6. Symptoms per underlying disease

    Time frame: 4 weeks

    Number of participants with assessed complaints (pain, sleeping problems, dry mouth, dysphagia, anorexia, constipation, nausea, dyspnoea, fatigue, anxiety, depressed mood and confusion) per underlying disease (most probably incurable cancer, chronic obstructive pulmonary disease, heart failure and end-stage renal disease).

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: MuSt-PC

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2018
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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