Multiple Symptoms in Cancer Patients a Cross Sectional Multi Center Study

Study Overview
=================
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.

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

Conditions
-----------------
Cancer

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cancer patients<br>in and out patients of 5 German university hospitals currently undergoing cancer treatment | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom burden (intensity & functional impairment) (MDASI) |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distress thermometer |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fatigue, Cancer, Symptom burden, Symptom cluster, Distress, Pain, Sleep disorder, HRQoL