A Stepped Wedge Cluster Randomized Controlled Trial to Assess a Strategy Aiming to Optimize Psychosocial Outcomes in Patients With Cancer
- Conditions
- Cancer
- Interventions
- Behavioral: HQIS implementation
- Registration Number
- NCT03008993
- Lead Sponsor
- Istituti Ospitalieri di Cremona
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 762
- Age > 18
- Diagnosis (histological or cytological) of solid tumor communicated to the patient within the previous two months
- About to start a new medical cancer treatment: chemotherapy (IV or oral), molecular target drugs, hormonal therapy, immunotherapy
- Expected survival > 3 months
- Good comprehension of the Italian language
- Who have read, understood, and signed the informed consent.
- Previous chemotherapy or other medical cancer treatment
- Recruited in a previous epoch of the study (that is, patients can only participate during one epoch)
- Currently participating in other trials which imply the completion of Patient Reported Outcomes (PROs) in the same period
- Hospitalized
- Currently receiving psychiatric treatment
- Affected by mental or psychiatric disorders, due to cancer or coexisting illness, which interfere with the state of consciousness or impede judgment
- Inability to complete the questionnaire or ensure participation in the three-month follow-up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Post-Intervention HQIS implementation 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.
- Primary Outcome Measures
Name Time Method European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) -C30 baseline - 3rd month Quality of life, the primary endpoint of the study, will be assessed with the validated Italian version of the EORTC QLQ-C30 questionnaire, specific for patients with cancer . The tool is self-administered, and comprises 30 questions, 24 of which form nine multi-item scales representing the different aspects, or domains, of QoL: a global health status / QoL scale, five functional scales (physical, role, emotional, cognitive and social), and three symptom scales (fatigue, pain, nausea and vomiting), as well as 6 single items assessing additional symptoms (dyspnoea, loss of appetite, insomnia, constipation, diarrhea) and perceived financial impact of the disease.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Azienda USL- Presidio "Di Summa - Perrino"
🇮🇹Brindisi, Italy
Azienda Ospedaliera di Cosenza
🇮🇹Cosenza, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
🇮🇹Pesaro, Italy
Azienda Ospedaliera Universitaria Policlinico Universitario "G.Martino"
🇮🇹Messina, Italy
IRCCS Istituto Tumori
🇮🇹Milano, Italy
Azienda Ospedaliera dei Colli
🇮🇹Napoli, Italy
Azienda Sanitaria Locale
🇮🇹Nuoro, Italy
ASL Ospedale SS Annunziata
🇮🇹Sassari, Italy
Azienda Ospedaliera "P Giaccone"
🇮🇹Palermo, Italy
Azienda Ospedaliero Universitaria "San Luigi Gonzaga"
🇮🇹Torino, Italy
Azienda Ospedaliera Sanitaria Provinciale
🇮🇹Trapani, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza
🇮🇹Torino, Italy
Azienda Ospedaliero-Universitaria di Udine
🇮🇹Udine, Italy
Ospedale Sacro Cuore "Don Calabria" Presidio ospedaliero accreditato
🇮🇹Verona, Italy