Cancer Clinical Trial
Official title:
Trial Clinico Controllato e Randomizzato, Con Disegno a Cluster Stepped-wedge, Per Valutare Una Strategia Volta ad Ottimizzare Gli Outcomes Psicosociali in Pazienti Affetti da Cancro
INTRODUCTION 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 randomized trial is designed to assess whether
the introduction of the strategy in oncology wards improves patient quality of life.
METHODS AND ANALYSIS This is a multicenter, incomplete stepped-wedge cluster randomized
controlled trial, where the intervention strategy is sequentially carried out in three groups
of centers (clusters with 5 centers each) and in three equally spaced time periods (epochs)
(every 4 months). The study also includes an initial epoch during which 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 (unit of randomization) and
assessed at an individual level with cross-sectional model. 720 patients will be included,
i.e. 60 patients in each cluster for every detection epoch.
Primary aim is to evaluate the effectiveness of the HQIS vs standard care in terms of
improvement of at least one of two domains of HRQoL using the EORTC QLQ-C30 questionnaire,
detected at baseline and 3 months after enrolment.
The HQIS comprises three phases: 1) clinician training - to improve communication-relational
skills and to instruct on the project; 2) center support - 4 on site visits by experts of the
project team, aimed to introduce the project and boost motivation, instruct staff on how to
implement recommendations, help with context analysis and identification of solutions; assess
actual implementation in the center; 3) implementation of EBM recommendations.
ETHICS AND DISSEMINATION Ethics committee review approval has been obtained from the Ethics
Committee of Parma. Results will be disseminated at conferences, in peer-reviewed and
professional journals intended for policymakers and managers.
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