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

NCT03665168 | Completed

• 1 other identifier: 201800366
• Study Type: observational
• Target: 659
• Locations: 1 country
• Sites: 1

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.

Conditions

Palliative Medicine

Outcome Measures

Primary Outcomes (1)

• Prevalence of multiple, simultaneously occurring symptoms

  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).

  4 weeks

Secondary Outcomes (6)

• Prevalence of each separate symptom

  4 weeks

• Clinically relevant symptoms

  4 weeks

• Quality of life (single question with numeric rating scale)

  4 weeks

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

  4 weeks

• Symptoms per care setting

  4 weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Study Officials

• An KL Reyners, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 11, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

NL (1)