Development of an EORTC QoL Module for Pancreatic NET: Phases 1-3 v1.0
Research type
Research Study
Full title
To adapt the existing EORTC QLQ-GINET21 Module to develop a specific module for use in patients with Pancreatic Neuroendocrine Tumour (Phases 1-3)
IRAS ID
197984
Contact name
John Ramage
Contact email
Sponsor organisation
Hampshire Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Patient reported outcomes such as quality of life (QoL) are increasingly used both in clinical trials and routine clinical care. The European Organisation for Research into Treatment of Cancer (EORTC) ‘QLQ-C30’ is an internationally used questionnaire to assess general QoL and is considered suitable for use in patients with all cancer types. This core questionnaire can be supplemented by modules specific to cancer type and in 2013 the QLQ-GINET21 questionnaire module was developed with the aim to be suitable for patients with all types of gastrointestinal Neuroendocrine tumours(NETs). WHO: Significant differences, however, exist between NETs from gut and pancreatic origin (pNET) with a variety of distinct hormonal syndromes affecting some patients with pNET. Patients with pNET can experience specific disease symptoms, receive different treatments and hence experience different treatment side effects. NET specialist clinicians now consider that the GINET21 module should be re-developed for patients with pNET and in particular for those patients with hormonal syndromes.
WHERE: This international, multi-centre study will take place in clinical centres in Europe (UK, Germany, Italy, Spain and Poland) and is expected to be conducted over two years.
HOW: This is an observational study using questionnaires and covers Phase 1 and 3 of EORTC module development. All pNET patients will receive full written information and time to consider consent to participate. In Phase 1 patients have an in depth interview with a specialist NET ‘clinician/health professional’ to complete the QLQ-C30 and then review and comment on a list of possible pNET module questions and to suggest relevant issues missing from the list. In Phase 3 different pNET patients would consent to an interview with a specialist NET ‘clinician/health professional’ to complete QLQ-C30 and then pre-test a provisional list of module questions and give a response score for each question, together with rating of relevance and importance. Afterwards patients comment on the completeness and acceptability of the module questions.REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0245
Date of REC Opinion
12 Jul 2016
REC opinion
Further Information Favourable Opinion