Update of EORTC BR23 study: Phases I-III

• Research type

  Research Study

• Full title

  Update of the EORTC QLQ-Breast Cancer Module (EORTC QLQ-BR23): Phases I-III

• IRAS ID

  198201

• Contact name

  Parisa Sinai

• Contact email

  parisa.sinai@bristol.ac.uk

• Sponsor organisation

  University of Bristol

• Duration of Study in the UK

  1 years, 8 months, 2 days

• Research summary

  Breast cancer is a chronic disease resulting in a long lifetime for patients with side-effects of disease and treatments. However, it is still the most frequent type of cancer in Europe (55,000 women annually). Therefore there is growing interest in women's quality of life (QoL) and effects of treatment for breast cancer survivors. Health related QoL (HRQL) is recognised to play an important role in breast cancer care.

  One of the first questionnaires developed was the EORTC QLQ-BR23 published in 1996 and used by numerous researchers and doctors since then. However, standard treatments for breast cancer have changed in the past 15 years (e.g. types of surgery to the breast and axilla, radiotherapy and drugs used). New treatments have brought new side-effects and changes to QoL that are presently not well covered by the EORTC QLQ-BR23. An update of the questionnaire will be important, both from a clinical and scientific point of view.

  The aim of this study is to create a QoL questionnaire with more relevant questions related to new treatment options. This process will cover:

  Phase I:

  a) Systematic Review of the literature
  
  b) Interviews with at least 60 breast cancer patients (5-10 from each centre) and Health Care Professionals (5 per country)
  
  Phase II:

  a) Operationalization of the issues into patient-reported questions or items (as the questionnaire is developed)
  
  b) Interviews with 1-2 Health Care Professionals per country

  Phase III:

  a) Pre-testing the new module for understanding, comprehensiveness and applicability (according to the EORTC Module Development Guidelines)

  b) Patient Interviews (10-15 patients per centre) at different stages of breast cancer treatment from 14 centres comprising 12 countries including North, Central and Southern Europe and Asia.

  Three UK centres will participate (2 x Bristol and 1 x Leeds)

  The study is expected to take 2 years and result in a 'modernised' EORTC QLQ-BR23 questionnaire.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  16/SC/0295

• Date of REC Opinion

  4 Aug 2016

• REC opinion

  Further Information Favourable Opinion