Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT03665168
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.
Study:
NCT03665168
Study Brief:
Protocol Section:
NCT03665168