H. Flechtner et al., Quality of life assessment in Hodgkin's disease: A new comprehensive approach - First experiences from the EORTC/GELA and GHSG trials, ANN ONCOL, 9, 1998, pp. 147-154
Previous reports from available trials have dealt with negative long-term s
equelae in Hodgkins disease (HD) survivors. There is, however, a lack of lo
ngitudinal data showing the correlation between outcome and various treatme
nt-related variables and the process of re-adaptation into normal life afte
r the end of treatment. In order to investigate the quality of life (QoL) o
f patients with HD in different dimensions during active treatment and foll
ow-up and to identify longitudinal patterns of QoL dimensions during re-ada
ptation to normal life within the EORTC Lymphoma Cooperative Group and Grou
pe D'Etude des Lymphomes de L'Adulte (EORTC/GELA) and the German Hodgkin St
udy Group (GHSG), QoL assessment strategies were put into use over the last
three to five years. Furthermore, the efforts aimed at obtaining cross-cul
tural comparisons between the participating countries and study groups (EOR
TC/GELA and GHSG). Within the randomised EORTC/GELA Trial 'H8' for clinical
stage I-II HD which started in September 1993, patients receive a QoL ques
tionnaire for completion at each follow-up visit during the first 10 years
after the end of active therapy. The corresponding 'HD8' study of the GHSG
employs the assessment of QoL during and after active treatment periods. Wi
thin both studies, the EORTC QLQ C38 is used for QoL assessment incorporate
d in the QLQ-S (quality of life questionnaire for survivors), which additio
nally addresses the aspects of fatigue/malaise, sexuality, specific side ef
fects, and retrospective evaluation of treatment. In total the QLQ-S includ
es 45 questions on 14 functional, symptom. and fatigue scales, 15 additiona
l single items, and 3 open questions. In addition to the longitudinal QoL a
ssessment, the GHSG carried out cross-sectional QoL trials with all cured s
urviving patients from the past HD1-6 studies and a matched normal control
sample employing the QLQ-S and the life situation questionnaire (LSQ), an i
nstrument covering objective data from 45 domains of life. To date, within
the trials H8 and HDS over 3000 QoL questionnaires from more than 800 patie
nts from ten countries are available for analysis. Replication of the psych
ometric properties of the scales revealed satisfactory results using factor
analyses and reliability testing across languages for the QLQ-S. A feasibi
lity analysis showed generally a good acceptance of the questionnaire by th
e patients and physicians. QoL assessment within international multicentre
trials in HD proved feasible within the two differently organised study gro
ups of EORTC/GELA and GHSG. The use of subjective QoL data (QLQ-S) together
with objective data (LSQ) in a combined cross-sectional and longitudinal t
rial system will give the most comprehensive insight into the problems of t
he re-integration process into normal life after cure. This information wil
l provide the basis for the development of remedies/help measures and possi
ble modifications of treatment strategies. The current approach will be fur
ther developed in close collaboration between both trial groups, and nest s
teps will include translation of the LSQ into other languages and adaptatio
n to various cultural circumstances.