International validation of the EORTC QLQ-ANL27
Research type
Research Study
Full title
An International Field Study to test the Reliability and Validity of the EORTC Anal Cancer Module (the EORTC QLQ-ANL27) and the EORTC QLQ-C30 for assessing Health Related Quality of Life in patients with Anal Cancer
IRAS ID
229434
Contact name
Anne-Sophie Darlington
Contact email
Sponsor organisation
University of Southampton
Clinicaltrials.gov Identifier
17/WM/0396, REC West Midlands-Coventry & Warwickshire
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The objective of the study is to carry out international field testing of the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Anal Cancer Health-related Quality of Life (HRQoL) Questionnaire Module (the EORTC QLQ-ANL27). The questionnaire was designed to include all relevant and important HRQoL issues specific to patients with anal cancer treated with chemoradiotherapy (CRT). The questionnaire was developed according to EORTC Module development guidelines over three phases: Phase 1 involved the generation of HRQoL issues relevant to patients undergoing CRT for primary or recurrent (locoregional) anal cancer. Issues were identified from a literature review and interviews with patients and health care professionals. In Phase 2 these issues formed questions which were then pilot tested and reviewed in Phase 3 by a separate group of anal cancer patients. The final version of the questionnaire, the EORTC QLQ-ANL27 is designed to supplement the EORTC QLQ (core questionnaire applicable to patients across cancer types). The EORTC QLQ-ANL27 now requires testing with a larger number of patients across different cultures in order to determine its measurement properties and acceptability and this is the focus of the current study. Patients with anal cancer who have not previously been involved in Phases 1-3 will be interviewed and asked to complete the questionnaire alongside the EORTC QLQ-C30. They will then complete a de-briefing questionnaire asking them to share their thoughts on the questionnaire in terms of whether anything is missing from the questionnaires and whether any of the questions were confusing, difficult to answer, or upsetting. In the debriefing interview, patients will also be asked how long it took to complete the QLQ-ANL27 and whether they needed any help completing it. Some participants will be asked to complete the questionnaire on two occasions to check for consistency or changes in responses.
Lay summary of study results: Anal cancer is rare and is currently treated with chemotherapy and radiotherapy (CRT) in combination. While treatment outcomes are promising, their side effects often have long lasting effects on health-related quality of life (HRQoL). There is little research into these side-effects and there is no anal cancer specific questionnaire to assess HRQoL. In order to develop a HRQoL questionnaire specifically for anal cancer patients, we reviewed the literature on anal cancer and interviewed patients and healthcare professionals (HCPs) from 8 countries. We then developed a list of 197 issues, which was refined into a 65-item questionnaire. The final questionnaire, the “EORTC QLQ-ANL27” includes 27 questions covering pain, bowel, sexual and stoma care problems which may help the management of side-effects and provision of psychological support. Asking patients to complete this questionnaire may help to understand where they need support.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
17/WM/0396
Date of REC Opinion
20 Nov 2017
REC opinion
Further Information Favourable Opinion