HRQoL assessment in metastatic or recurrent/ persistent anal cancer

  • Research type

    Research Study

  • Full title

    A feasibility study to develop a health-related quality of life module for metastatic and recurrent/ persistent anal cancer or to add metastatic anal cancer-specific items to the existing EORTC ANL-27

  • IRAS ID

    328317

  • Contact name

    Samantha Sodergren

  • Contact email

    S.C.Sodergren@soton.ac.uk

  • Sponsor organisation

    University of Southampton

  • Duration of Study in the UK

    1 years, 2 months, 1 days

  • Research summary

    The European Organisation of Research and Treatment of Cancer's Quality of Life group (EORTC QLG) has developed a four-phase framework that can be used to develop and validate quality of life questionnaires for individuals with cancer. These are developed as modules to supplement their existing EORTC core quality of life questionnaire. the 'QLQ-C30. For example, modules have previously been developed for endometrial cancer (QLQEN24), bone metastases (QLQ-BM22) and cancer-related fatigue (QLQ-FA12). The four-phase approach comprises a literature review followed by interviews with patients and clinicians (Phase 1), construction of a questionnaire (Phase 2), refinement of the questionnaire (Phase 3) and finally administration of the questionnaire to an international sample in a full validation study (Phase 4).

    The present study aims to contribute to the development of a module designed to assess HRQoL issues in patients with metastatic or recurrent anal cancer. The study aims to undertake Phases 1 and 2 of the above module development process.

  • REC name

    East Midlands - Leicester Central Research Ethics Committee

  • REC reference

    23/EM/0157

  • Date of REC Opinion

    27 Jul 2023

  • REC opinion

    Further Information Favourable Opinion