A Stepped Wedge Cluster Randomized Controlled Trial to Assess a Strategy Aiming to Optimize Psychosocial Outcomes in Patients With Cancer

Summary

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.

Conditions

• Cancer

Interventions

BEHAVIORAL

HQIS implementation

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma

  collaborator OTHER

• Centro di Riferimento Oncologico - Aviano

  collaborator OTHER

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  collaborator OTHER

• Istituto Di Ricerche Farmacologiche Mario Negri

  collaborator OTHER

• IRCCS Sacro Cuore Don Calabria di Negrar

  collaborator OTHER

• Azienda USL Reggio Emilia - IRCCS

  collaborator OTHER_GOV

• Istituti Ospitalieri di Cremona

  lead OTHER

Principal Investigators

• Rodolfo Passalacqua · Istituti Ospitalieri Cremona

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-17

Primary Completion

2018-11-06

Completion

2018-11-06

Countries

• Italy

Study Locations