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Multiple Symptoms in Cancer Patients a Cross Sectional Multi Center Study (ProKID)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01317355
First Posted: March 17, 2011
Last Update Posted: September 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Patrick Jahn, Martin-Luther-Universität Halle-Wittenberg
March 16, 2011
March 17, 2011
September 27, 2012
June 2010
April 2011   (Final data collection date for primary outcome measure)
Symptom burden (intensity & functional impairment) (MDASI) [ Time Frame: 24 hours ]
Same as current
Complete list of historical versions of study NCT01317355 on ClinicalTrials.gov Archive Site
Distress thermometer [ Time Frame: 7 days ]
Same as current
Not Provided
Not Provided
 
Multiple Symptoms in Cancer Patients a Cross Sectional Multi Center Study
Prevalence of Multiple Symptoms in Cancer Patients a Cross Sectional Prospective Multi Center Study
This study will assess the occurrence of multiple symptoms in cancer patients of 5 German university hospitals. Primary goal of the study is to assess the prevalence of multiple symptoms and related symptom clusters (e.g. pain, fatigue and sleep disorder).

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample
in and out cancer patients of 5 German university hospitals currently undergoing cancer treatment
Cancer
Not Provided
cancer patients
in and out patients of 5 German university hospitals currently undergoing cancer treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
697
June 2011
April 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • cancer patients (ICD 10)
  • 18 to 80 years of age
  • ongoing treatment
  • informed consent

Exclusion Criteria:

  • not speaking and writing German
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01317355
ProKID
No
Not Provided
Not Provided
Patrick Jahn, Martin-Luther-Universität Halle-Wittenberg
Martin-Luther-Universität Halle-Wittenberg
Not Provided
Principal Investigator: Margarete Landenberger, Prof.Phd Department for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg
Martin-Luther-Universität Halle-Wittenberg
September 2012