EORTC Module QLQ-CR29 update v.1.1
Research type
Research Study
Full title
The European Organisation for Research and Treatment of Cancer (EORTC): Module QLQ- CR29 update (Phases I and II)
IRAS ID
363554
Contact name
Jean Uniacke
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
1 years, 4 months, 8 days
Research summary
The European Organisation for Research and Treatment of Cancer (EORTC) colorectal module (QLQ‑CR29) is the most widely used patient‑reported outcome (PRO) measure in colorectal cancer (CRC) trials. Although validated in 2009, subsequent advances in CRC treatment—including organ preservation, neoadjuvant chemotherapy, and molecularly targeted agents—have introduced new health‑related quality of life (HRQoL) concerns not adequately captured by existing questionnaires (C30, CR29, LARS). Key issues such as bowel, urinary, and sexual dysfunction remain underrepresented. Recent European Society for Medical Oncology (ESMO) guidelines for metastatic, localized, and rectal cancer provide a framework for updating the CR29, alongside a systematic review of adverse events reported in investigational brochures of systemic agents.
The overall aim of this project is to update the CR29 to ensure comprehensive coverage of HRQoL issues relevant to contemporary CRC management. Specifically, this protocol describes Phase I (issue generation through literature review and stakeholder interviews) and Phase II (item set development). These phases will also inform exploratory work toward a core outcome set (COS) for organ preservation, building on prior expert consensus recommendations.
The study design follows EORTC module development guidelines and leverages the EORTC Quality of Life Group (QLG) item library. Phase I comprises: (1) a scoping review of HRQoL issues in organ preservation, systemic therapies, and standard care, supplemented by adverse event data; (2) interviews with healthcare professionals and patients, including those undergoing surgical approaches, to identify gaps and rank issue relevance; and (3) item/issue mapping, reviewed at an international consensus meeting, to generate a provisional list.
Phase II involves: (4) item set development, addressing wording and cross‑cultural adaptation challenges; and (5) an online Delphi survey and consensus meeting with English-speaking patients and professionals to agree on a COS for organ preservation approaches. Findings will be reported to the EORTC QLG Module Development Committee for peer review.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
26/NW/0058
Date of REC Opinion
23 Apr 2026
REC opinion
Further Information Favourable Opinion