to study search History No further version available for comparison

Investigating the German response scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) – a three-step approach

Organizational Data

DRKS-ID:
DRKS00012759
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2017-08-04
Last update in DRKS:
2017-08-04
Registration type:
Retrospective

Acronym/abbreviation of the study

EORTC Response Scale

URL of the study

No Entry

Brief summary in lay language

The original EORTC questionnaire assess the quality of life of patients with cancer. The questionnaie was developed in English, and other language versions, including German, were created in parallel. With exception of two items, all items of the actual Version are scored on a 4-point Likert scale: 1 “not at all”, 2 “a little”, 3 “quite a bit”, and 4 “very much”. The German equivalents have been translated as 1 “überhaupt nicht”, 2 “wenig”, 3 “mäßig”, and 4 “sehr”. The German term "mäßig" is close to the term "wenig", thus violating the interval properties of the scale. The present project will investigate whether the "mäßig" should be replaced by another term and whether this improves the measurement properties of the scale. Patients participating in this study will fill in the questionnaire twice, once in the conventional design ("mäßig") and once in the updated design with the response alternative "ziemlich". The order of the questionnaire designs and the presentation modes (paper/pencil versus computer) will be randomized.

Brief summary in scientific language

The original EORTC questionnaire was formulated in English, and other language versions, including German, were created in parallel. With exception of two items, all items of the actual Version are scored on a 4-point Likert scale: 1 “not at all”, 2 “a little”, 3 “quite a bit”, and 4 “very much”. The German equivalents have been translated as 1 “überhaupt nicht”, 2 “wenig”, 3 “mäßig”, and 4 “sehr”. The German term "mäßig" is close to the term "wenig", thus violating the interval properties of the scale. The present project will investigate whether the "mäßig" should be replaced by another term and whether this improves the measurement properties of the scale.

Health condition or problem studied

Free text:
Adaption of the German version of the questionnaire for cancer patients EORTC QLQ-C30
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Step I investigates the properties of the critical response term “mäßig” and its alternatives.
Arm 2:
Step II refers to the development of an updated German EORTC QLQ-C30 version with an improved response scale.
Arm 3:
Step III: Both questionnaires, conventional and updated, are available in a paper/pencil and a table version. Each patient fills in 2 qestionnaires and their assignment is randomized. Arm 3: conventional questionnaire/paper version
Arm 4:
Step III: updated questionnaire/paper version
Arm 5:
Step III: conventional questionnaire/tablet version
Arm 6:
Step III: updated questionnaire/tablet version

Endpoints

Primary outcome:
The primary endpoint is the score of the EORTC QLQ-C30 as calculated according to the scoring manual. The score will be calculated twice, with regard to the the first and the second assessment. The critical value of interest is the difference between scores of the conventional and the updated version. This difference will be assessed in the between (group comparisons) and within (before-after effects) conditions.
Secondary outcome:
No Entry

Study Design

Purpose:
Other
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Austria
  • Germany
  • Switzerland
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center Klinikum St. Georg Leipzig
  • University medical center Regensburg
  • University medical center Halle

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2016-04-01
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
500
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Cancer, informed consent, ability to fill in a questionnaire

Exclusion Criteria

No Entry

Addresses

Primary Sponsor

Universitätsklinikum RegensburgZentrum für Klinische Studien
Prof. Dr. Michael Koller
Franz-Josef-Strauss-Allee 11
9053 Regensburg
Germany
Telephone:
0941 944 5630
Fax:
0941 944 4462
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum RegensburgZentrum für Klinische Studien
Prof. Dr. Michael Koller
Franz-Josef-Strauss-Allee 11
9053 Regensburg
Germany
Telephone:
0941 944 5630
Fax:
0941 944 4462
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universitätsklinikum RegensburgZentrum für Klinische Studien
Prof. Dr. Michael Koller
Franz-Josef-Strauss-Allee 11
9053 Regensburg
Germany
Telephone:
0941 944 5630
Fax:
0941 944 4462
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universitätsklinikum RegensburgZentrum für Klinische Studien
Prof. Dr. Michael Koller
Franz-Josef-Strauss-Allee 11
9053 Regensburg
Germany
Telephone:
0941 944 5630
Fax:
0941 944 4462
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

European Organisation for Research and Treatment of Cancer
Av. E. Mounierlaan 83
1200 Brüssel
Belgium
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Universität Regensburg
Landshuter Straße 4
93047 Regensburg
Germany
Telephone:
+49-941-9435370
Fax:
+49-941-9435369
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2014-07-14
Ethics committee number:
14-101-0209
Vote of the Ethics Committee:
Approved
Date of the vote:
2014-07-23

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
Other secondary IDs:
Z-2014-0368-2 - Zentrum für Klinische Studien Regensburg
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry