Clinical trial NCT01317355: Multiple Symptoms in Cancer Patients a Cross Sectional Multi Center Study
Official title: Prevalence of Multiple Symptoms in Cancer Patients a Cross Sectional Prospective Multi Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Cancer
Symptom burden
Symptom cluster
Distress
Pain
Fatigue
Sleep disorder
HRQoL
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 697
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: in and out cancer patients of 5 German university hospitals currently undergoing cancer treatment

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* not speaking and writing German

Primary outcomes:
measure: Symptom burden (intensity & functional impairment) (MDASI)
timeFrame: 24 hours
Secondary outcomes:
measure: Distress thermometer
timeFrame: 7 days
Other outcomes:
Locations:
city: Halle
country: Germany
facility: Department for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg
state: Saxony-Anhalt
Study officials:
affiliation: Department for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg
name: Margarete Landenberger, Prof.Phd
role: PRINCIPAL_INVESTIGATOR
References: