Multiple Symptoms in Cancer Patients a Cross Sectional Multi Center Study (ProKID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patrick Jahn, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT01317355
First received: March 16, 2011
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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).


Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of Multiple Symptoms in Cancer Patients a Cross Sectional Prospective Multi Center Study

Resource links provided by NLM:


Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • Symptom burden (intensity & functional impairment) (MDASI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distress thermometer [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 697
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
cancer patients
in and out patients of 5 German university hospitals currently undergoing cancer treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • not speaking and writing German
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317355

Locations
Germany
Department for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg
Halle, Saxony-Anhalt, Germany, 06097
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Investigators
Principal Investigator: Margarete Landenberger, Prof.Phd Department for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg
  More Information

No publications provided

Responsible Party: Patrick Jahn, Dr. rer. medic. Patrick Jahn, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01317355     History of Changes
Other Study ID Numbers: ProKID
Study First Received: March 16, 2011
Last Updated: September 26, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
Cancer
Symptom burden
Symptom cluster
Distress
Pain
Fatigue
Sleep disorder
HRQoL

ClinicalTrials.gov processed this record on July 20, 2014