Our group previously demonstrated the feasibility of the Hucare Quality Improvement Strategy – HQIS, aimed at integrating into practice 6 psychosocial interventions recommended by international guidelines. This trial will assess whether the introduction of the strategy in oncology wards improves patient Health-related quality of life (HRQoL).
Multicenter, incomplete stepped-wedge cluster randomized controlled trial, conducted in three clusters of 5 centers each, in three equally spaced time epochs. The study also includes an initial epoch when none of the centers is exposed to the intervention, and a final epoch when all centers will have implemented the strategy. The intervention is applied at a cluster level, and assessed at an individual level with cross-sectional model. 720 patients who received a cancer diagnosis in the previous 2 months and about to start medical treatment will be enrolled. Primary aim is to evaluate the effectiveness of the HQIS vs standard care in terms of improvement of at least one of two domains (emotional and social functions) of HRQoL using the EORTC QLQ-C30 questionnaire, at baseline and at 3 months. This outcome was chosen because cancer patients generally exhibit low HRQoL, particularly at certain stages of care, and because it allows to assess the strategy’s impact as perceived by patients themselves. The HQIS comprises three phases: 1) clinician training - to improve communication-relational skills and instruct on the project; 2) center support – 4 on site visits by experts of the project team, aimed to boost motivation, help with context analysis and identification of solutions; 3) implementation of EBM recommendations at the center.
Clinical trial identification
Legal entity responsible for the study
Italian Association of Medical Oncology (AIOM)
Association of Medical Oncology (AIOM); MEDeA (non-profit volunteer association)
All authors have declared no conflicts of interest.