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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01317355
Acronym
ProKID
Enrollment
697
Registered
2011-03-17
Start date
2010-06-30
Completion date
2011-06-30
Last updated
2012-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

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

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.

Interventions

None listed

Sponsors

Martin-Luther-Universität Halle-Wittenberg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* not speaking and writing German

Design outcomes

Primary

MeasureTime frame
Symptom burden (intensity & functional impairment) (MDASI)24 hours

Secondary

MeasureTime frame
Distress thermometer7 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026