Gender Neutral
Type Module
Testing Phase IV - in development
Principal investigator(s)
Lonneke van de Poll-Franse
IKNL
Eindhoven, Netherlands
, Fabio Efficace
GIMEMA
Rome, Italy
Study coordinator(s)
Simone Oerlemans
Comprehensive Cancer Organization (IKNL)
Utrecht, Netherlands

Project summary

Advances in the management of patients with lymphoma or chronic lymphocytic leukaemia (CLL) have changed the survival outcomes dramatically in the last two decades. The number of new agents for these patients is increasing and quality of life (QoL) is becoming a primary objective. Unfortunately, questionnaires to assess disease-specific QoL among patients with Hodgkin lymphoma (HL), high-grade non-Hodgkin lymphoma (HG-NHL), low-grade non-Hodgkin lymphoma (LG-NHL) and CLL are lacking. According to the standard EORTC QLG Phase 1-3 procedures four modules were developed: a module with 27 items for HL (EORTC QLQ-HL27), a module with 29 items for HG-NHL (EORTC QLQ-NHL-HG29), a module with 20 items for LG-NHL (EORTC QLQ-NHL-LG20) and a module with 17 items for CLL (EORTC QLQ-CLL17). The items are conceptualized in several multi-item scales: symptom burden, physical condition/fatigue, worries/fears on health and functioning, emotional impact (not in the CLL module), neuropathy (only in the HG-NHL module).

The aim of the present Phase IV study is to perform an international validation of these four modules in conjunction with the EORTC QLQ-C30 in people diagnosed with either HL, HG-NHL, LG-NHL or CLL, with different stages of disease and after different treatment lines. Standard psychometric analyses will be employed to evaluate the hypothesized scale structure of the QLQ-HL27, QLQ-NHL-HG29, QLQ-NHL-LG20, QLQ-CLL17 and their internal consistency, convergent and discriminate validity. The sample size is determined by the number of items in the questionnaire and will consist of 324 patients with HL, 204 patients with CLL, 348 patients with HG-NHL and 240 patients with LG-NHL. Patients will be invited to complete the QLQ-C30 and the specific module for their tumor, followed by a debriefing questionnaire. Sociodemographic and clinical data will be recorded by the healthcare professional. For the test-retest measurement the study sample will be composed of 125 randomly selected patients from each tumour group who completed the first measurement.

This study will provide four validated modules for use in clinical trials and observational research in conjunction with the EORTC QLQ-C30 for assessment of QoL for patients with HL, HG-NHL, LG-NHL and CLL.

Achievements

Phase 1 – HCP interviews: Completed April 2013 (countries that participated: Italy, Taiwan, Netherlands and the UK)

Phase 1 – Patient interviews: Completed June 2013 (countries that participated: Italy, Taiwan, Netherlands and the UK)

Phase 2 – Conversion of QoL issues into set of items: Completed July 2013 (Phase 1 and 2 report approved by MDC in September 2013).

Phase 3 – Pre-testing of provisional module: data collection completed October 2014. Overall, 67 patients with HL, 86 patients with CLL, 117 patients with aggressive NHL and 67 patients with indolent NHL from Italy, France, the Netherlands, UK and Austria have been included. Phase III report has been approved by the MDC (07-06-2015).

Phase 4- Phase 4 grant awarded in December 2016. Ethical approval is obtained in almost all countries. The first patient was recruited in July 2017 and up to now 120 patients have been recruited in 7 countries.

Future plans

Patient recruitment and data collection is expected to end in April 2019. Analyses and report writing will be performed after that.

For patients

In this study we are developing a questionnaire for patients who have or had Hodgkin lymphoma. Patients may experience changes in their body due to the disease or/and the treatments they receive. This might have a negative impact on a patients subjective wellbeing. With the questionnaire we want to find out more about how patients feel, both physically and emotionally. In order to collect this information, brief and simple questionnaires, designed to be completed by patients themselves, will be developed and tested in this study.

Publications

van de Poll-Franse L, Oerlemans S, Bredart A, Kyriakou C, Sztankay M, Pallua S, Daniëls L, Creutzberg C, Cocks K, Malak S, Caocci G, Molica S, Chie W, Efficace F; EORTC Quality of Life Group. International development of four EORTC disease-specific quality of life questionnaires for patients with Hodgkin lymphoma, high- and low-grade non-Hodgkin lymphoma and chronic lymphocytic leukaemia. Qual Life Res. 2018 Feb;27(2):333-345. doi: 10.1007