NCT01317355

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
697

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

10 months

First QC Date

March 16, 2011

Last Update Submit

September 26, 2012

Conditions

Cancer

Keywords

CancerSymptom burdenSymptom clusterDistressPainFatigueSleep disorderHRQoL

Outcome Measures

Primary Outcomes (1)

  • Symptom burden (intensity & functional impairment) (MDASI)

    24 hours

Secondary Outcomes (1)

  • Distress thermometer

    7 days

Study Arms (1)

cancer patients

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • not speaking and writing German

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg

Halle, Saxony-Anhalt, 06097, Germany

Location

MeSH Terms

Conditions

NeoplasmsSyndromePainFatigueSleep Wake Disorders

Condition Hierarchy (Ancestors)

DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsNervous System DiseasesMental Disorders

Study Officials

  • Margarete Landenberger, Prof.Phd

    Department for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. rer. medic. Patrick Jahn

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

June 1, 2010

Primary Completion

April 1, 2011

Study Completion

June 1, 2011

Last Updated

September 27, 2012

Record last verified: 2012-09

Locations

DE(1)