Multiple Symptoms in Cancer Patients a Cross Sectional 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).

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Key information

Conditions

Cancer Disease Fatigue Mental Disorders Neoplasms Nervous System Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Halle, Saxony-Anhalt, 06097, Germany

About this 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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

not speaking and writing German

Treatment and study plan

Primary outcomes

Symptom burden (intensity & functional impairment) (MDASI)

Time frame: 24 hours

Secondary outcomes

Distress thermometer

Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Registry information

Official study title

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

Acronym: ProKID

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Mar 17, 2011
Registry last updated: Sep 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed