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Phase IV Development of an EORTC QoL Cancer Survivorship Questionnaire and Three Site Specific Modules

Study ID: 53310
Short Title: QLG Survivorship 4
Trust Name: DCHFT,SFT,UHD,UHS
Recruitment Site: Dorset County Hospital,Poole Hospital,Royal Bournemouth Hospital,Salisbury District Hospital,Southampton General Hospital
Disease Area: SPCPS
Phase: N/A
Expected End Date: 15/06/2024
Postcode: DT1 2JY
SP2 8BJ
SO16 6YD
BH15 2JB
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

• Aged 18 years and older at diagnosis. • A confirmed cancer diagnosis of: breast, colorectal, prostate, bladder, gynecological (ovarian, cervix and endometrial), head and neck, lung, and testicular cancer, lymphoma (Hodgkin and Non-Hodgkin), melanoma, or glioma. • Between one and ten years post-primary treatment or treatment for recurrence with curative intent (exception glioma –not treated with curative intent- and maintenance therapies e.g. tamoxifen). • No evidence of active disease (exception glioma). • Before patients complete the questionnaire, written informed consent must be given according to ICH/GCP, and national/local regulations including commitment to complete questionnaires during the course of the study.

• Unable to speak English. • Participated in Phase 3b of the module development. • Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol. • Lack of mental capacity to complete the questionnaires. • More than one primary cancer diagnosis.

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 measure quality of life in cancer survivors (i.e. those that are > 1 year post-diagnosis and have a good prognosis). The study aims to undertake Phase 4 of the above module development process.

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