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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: HQIS implementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post-Intervention<br>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. | Behavioral: HQIS implementation<br> <br> |
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) -C30 | 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. | baseline - 3rd month |