Multiple Symptoms in Cancer Patients a Cross Sectional Multi Center Study

Cancer Clinical Trial

— ProKID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317355
• Other study ID #: ProKID
• Status: Completed
• Phase: N/A
• First received: March 16, 2011
• Last updated: September 26, 2012
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2012
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 697
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• cancer patients (ICD 10)

• 18 to 80 years of age

• ongoing treatment

• informed consent

Exclusion Criteria:

• not speaking and writing German

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
Germany	Department for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg	Halle	Saxony-Anhalt

Sponsors (1)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom burden (intensity & functional impairment) (MDASI)		24 hours	No
Secondary	Distress thermometer		7 days	No