Multiple Symptoms in Cancer Patients a Cross Sectional Multi Center Study (ProKID)
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Prevalence of Multiple Symptoms in Cancer Patients a Cross Sectional Prospective Multi Center Study|
- Symptom burden (intensity & functional impairment) (MDASI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Distress thermometer [ Time Frame: 7 days ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
in and out patients of 5 German university hospitals currently undergoing cancer treatment
Oncology patients experience a variety of symptoms as a result of disease and/or treatment. They often report co-occurrence of symptoms and functional impairments (Miaskowski 2007). To evaluate the prevalence of symptoms and identify symptom clusters and the influence of multiple symptoms on HRQoL, in and out patients of 5 German university hospitals currently undergoing cancer treatment are recruited. These patients are asked to complete the following instruments: Distress thermometer, health related quality of life questionnaire (EORTC QLQ C30) and MD. Anderson Symptom Inventory (MDASI (German version). In a subgroup of two participating hospitals patients, that score ≥ 3/10 (MDASI-subscales for pain, fatigue and/or sleep disorder) are asked to complete additional questionnaires: Brief Pain Inventory (BPI), Multidimensional Fatigue Inventory (MFI), Pittsburgh Sleep Quality Index (PSQI). The information gained will not be accessible for doctors in charge of the treatment and therefore not influence or alter the participants' treatment regimes.
Primary endpoint of the study is to assess the prevalence of multiple symptoms and related symptom clusters (e.g. pain, fatigue and sleep disorder). Secondary endpoints are: symptom burden (intensity of symptoms and functional impairments), impact of symptom burden on HRQoL.
The investigators aim to approve the value of standardized assessment of symptoms in clinical cancer care settings as an important precondition of early treatment and supportive care.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317355
|Department for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg|
|Halle, Saxony-Anhalt, Germany, 06097|
|Principal Investigator:||Margarete Landenberger, Prof.Phd||Department for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg|