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A Multidimensional Strategy to Improve Quality of Life of Patients With Multiple Symptoms and Palliative Care Needs (MuSt-PC)

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ClinicalTrials.gov Identifier: NCT03665168
Recruitment Status : Active, not recruiting
First Posted : September 11, 2018
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
A.K.L. Reyners, University Medical Center Groningen

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.

Condition or disease
Palliative Medicine

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.


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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Multidimensional Strategy to Improve Quality of Life of Patients With Multiple Symptoms and Palliative Care Needs
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Group/Cohort
Patients in the palliative stage
Adult patients in various settings will be included (General Practioners practices, home care facilities, general and academic hospitals, hospices) and with any underlying life-limiting disease.



Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665168


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: An KL Reyners, MD, PhD University Medical Center Groningen

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Responsible Party: A.K.L. Reyners, Prinicipal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03665168     History of Changes
Other Study ID Numbers: 201800366
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No