Development of an EORTC QOL Child Questionnaire
Research type
Research Study
Full title
Development of an EORTC Patient-Reported Outcome (PRO) Questionnaire for Quality of Life (QOL) of children with cancer: Phase I & II
IRAS ID
293896
Contact name
Samantha C Sodergren
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The assessment of quality of life (HRQOL) is a critical outcome measure for trials evaluating the risks and benefits of treatments for children with cancer. QOL assessment also plays an important role within clinical practice by facilitating communication between children, their parents and clinicians. It is therefore vital that QOL measures include questions which are of significance to children with cancer. While several paediatric QOL measures exist, previous research has identified shortcomings of those questionnaires when applied to children with cancer. The European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG) has an international reputation for the development of cancer QOL questionnaires with a core quality of life questionnaire (EORTC QLQ-C30) and supplementary modules specific to a particular tumour, condition or age group (older adults, adolescents and young adults). There is currently no EORTC QLG questionnaire specific to children. The objective of this multi-centre study is to use EORTC QLG guidelines to develop a measure asking about QOL concerns of relevance and importance to children aged 8-14 years with cancer and identify optimal response options which are appropriate for this age group. The study is led by the Medical University in Innsbruck, Austria and involves two phases: Phase I consists of a literature review as well as qualitative semi-structured interviews with 60 children (8-14 years), 45 parents and 30 health-care professionals (HCPs). In Phase Ib, a further 60 children (8-14 years) will be interviewed to evaluate the best response format (Smiley faces- vs. Likert-Scale) for these age groups.
In Phase II, the issues generated in Phase I will be operationalized and transformed into items and a preliminary questionnaire for children with cancer of 8-14 years will be constructed. In the UK a total of 30 children, 20 parents and 5 HCPs will be recruited.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
21/LO/0253
Date of REC Opinion
3 Jun 2021
REC opinion
Further Information Favourable Opinion