Quality of life assessment in Hodgkin's disease: A new comprehensive approach - First experiences from the EORTC/GELA and GHSG trials

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.