Development of a Core Outcome Set for Pancreatic Cancer Rehabilitation – A Study Protocol

Background Pancreatic cancer is an aggressive malignancy, with a five-year survival rate of approximately 10%. It carries a high symptom burden across all stages of disease and treatment trajectories. Rehabilitation, which has demonstrated benefits in other cancer populations, remains a relatively underexplored concept in pancreatic cancer. Emerging studies suggest that structured interventions may improve function, treatment tolerance, and quality of life; however, heterogeneity in study design, outcome measurement, and reporting hampers evidence synthesis and the formulation of clinical recommendations. To address this gap, the development of a Core Outcome Set (COS) for pancreatic cancer rehabilitation is warranted. Methods This protocol follows the Core Outcome Set – STandardised Protocol Statement (COS-STAP) guidance and the Core Outcome Set Standards for development (COS-STAD) recommendations. The COS will apply to adults with histologically confirmed pancreatic ductal adenocarcinoma undergoing any rehabilitative intervention across the cancer continuum. The COS will be developed in three sequential phases. In Phase 1, potential outcomes will be identified through a systematic review of existing rehabilitative studies, and semi-structured interviews with key stakeholders (patients, family members/caregivers, and healthcare professionals/researchers). In Phase 2, outcomes identified in Phase 1 will be prioritised using a multi-round electronic Delphi survey. In Phase 3, a consensus meeting with representatives from all stakeholder groups will finalise the COS. Discussion This study will deliver the first COS specific to pancreatic cancer rehabilitation, addressing the current inconsistency in outcome reporting and ensuring that future research captures domains relevant to all stakeholders. The COS will support the generation of high-quality, comparable evidence to inform clinical practice, improve patient-centred care, and optimise resource allocation. Ultimately, it will provide a unifying framework to guide rehabilitation research and care in this high-need population. Registration: COMET database https://www.comet-initiative.org/Studies/Details/3383, PROSPERO database (CRD420250645743).