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Prevalence of Multiple Symptoms in Cancer Patients a Cross Sectional Prospective Multi Center Study

18 Years
80 Years
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Trial Information

Prevalence of Multiple Symptoms in Cancer Patients a Cross Sectional Prospective Multi Center Study

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

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

Inclusion Criteria:

- cancer patients (ICD 10)

- 18 to 80 years of age

- ongoing treatment

- informed consent

Exclusion Criteria:

- not speaking and writing German

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Outcome Measure:

Symptom burden (intensity & functional impairment) (MDASI)

Outcome Time Frame:

24 hours

Safety Issue:


Principal Investigator

Margarete Landenberger, Prof.Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg


Germany: Ethics Commission

Study ID:




Start Date:

June 2010

Completion Date:

June 2011

Related Keywords:

  • Cancer
  • Cancer
  • Symptom burden
  • Symptom cluster
  • Distress
  • Pain
  • Fatigue
  • Sleep disorder
  • HRQoL