Quality of life sub-study

Quality of Life component of the EMBRACE study

 

Background and Objectives

Quality of life is an essential component for all patients with a diagnosis of cancer, undergoing treatment. It is well known that toxicity as scored by professionals does not correlate very well with patient scored symptoms, especially for grade 1 and 2 toxicity. Long term low grade toxicity might be important for health related quality of life.

 

One of the aims of this study is to establish a bench mark for clinical outcome with image based BT in a large patient population with respect to local control, survival, morbidity and quality of life. Since this will become a unique data set with detailed information on DVH parameters for organs at risk as well as toxicity information it will give us a tremendous opportunity to correlate those data to quality of life issues.

 

Material and methods

Two questionnaires will be used, both validated by the EORTC quality of life group: the QLQ-C30 version 3.0 and the QLQ-CX24. Validated translations are available for most languages. Translated modules are available on the EMBRACE website.

 

Flow chart

Time points for collection are: at baseline (prior to EBRT start) and to the regular Follow-ups 3, 6, 9, 12, 18, 24, 30, 48 and 60 months after treatment.

All patients with a valid base line and at least one follow up QOL questionnaires will be included in the analysis. The baseline questionnaire is considered valid only if filled out and dated by the patient before the starting date of trial treatment.

 

 

 

Data management

Data will be entered directly in the central database on the Embrace study website.

 

Statistics

Quality of life analysis will be done according to the guidelines provided by the EORTC Quality of Life Group. To obtain an estimate of the EORTC QLQ-C30 and CX-24 subscales at each of the fixed time points, a linear mixed model will be used. Single items will be analyzed using (ordinal) logistic regression with random effects. Wald’s test will be used to look for significant in- or decreases of QOL scores over time; to test the differences between subgroups, and score changes over time between subgroups.

 

Contact persons

Kathrin Kirchheiner, psycho oncologist, University of Vienna, Austria
Kathrin.Kirchheiner@akhwien.at
Remi Nout, radiation oncologist, Leiden University Medical Center, Leiden, the Netherlands
R.A.Nout@lumc.nl

 
Embrace