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CompletedNCT01317355ProKIDUpdated Sep 27, 2012

Multiple Symptoms in Cancer Patients a Cross Sectional Multi Center Study

An observational study in Cancer, sponsored by Martin-Luther-Universität Halle-Wittenberg. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-09-27.

Sponsored by Martin-Luther-Universität Halle-Wittenberg · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
697
Ages
18 Years to 80 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Cancer

Keywords

  • Cancer
  • Symptom burden
  • Symptom cluster
  • Distress
  • Pain
  • Fatigue
  • Sleep disorder
  • HRQoL
03

In context

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg is the lead sponsor of 62 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

in and out cancer patients of 5 German university hospitals currently undergoing cancer treatment

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • not speaking and writing German
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
697 participants (actual)

Groups and cohorts

  • cancer patients

    in and out patients of 5 German university hospitals currently undergoing cancer treatment

06

What researchers measure

Primary outcomes

  1. Symptom burden (intensity & functional impairment) (MDASI)

    Time frame: 24 hours

Secondary outcomes

  1. Distress thermometer

    Time frame: 7 days

07

Study locations

1 site
  • Department for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg
    Halle, Saxony-Anhalt 06097, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01317355
Lead sponsor
Martin-Luther-Universität Halle-Wittenberg
Responsible party
Patrick Jahn (Dr. rer. medic. Patrick Jahn, Martin-Luther-Universität Halle-Wittenberg) — Principal investigator
First posted
Mar 17, 2011
Start date
Jun 2010
Primary completion
Apr 2011
Completion
Jun 2011
Last update
Sep 27, 2012

Study contacts

Margarete Landenberger, Prof.Phd
principal investigator · Department for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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