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

Cancer Clinical Trial

— HuCare2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03008993
• Other study ID #: HuCare2
• Status: Completed
• Phase: N/A
• Start date: October 17, 2016
• Est. completion date: November 6, 2018

Study information

• Verified date: February 2019
• Source: Istituti Ospitalieri di Cremona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 762
• Est. completion date: November 6, 2018
• Est. primary completion date: November 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• HQIS implementation

Locations

Country	Name	City	State
Italy	Azienda USL- Presidio "Di Summa - Perrino"	Brindisi
Italy	Azienda Ospedaliera di Cosenza	Cosenza
Italy	Azienda Ospedaliera Ospedali Riuniti Marche Nord	Fano
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	Azienda Ospedaliera "P Giaccone"	Palermo
Italy	Azienda Ospedaliera Ospedali Riuniti Marche Nord	Pesaro
Italy	ASL Ospedale SS Annunziata	Sassari
Italy	Azienda Ospedaliero Universitaria "San Luigi Gonzaga"	Torino
Italy	Azienda Ospedaliero-Universitaria Città della Salute e della Scienza	Torino
Italy	Azienda Ospedaliera Sanitaria Provinciale	Trapani
Italy	Azienda Ospedaliero-Universitaria di Udine	Udine
Italy	Ospedale Sacro Cuore "Don Calabria" Presidio ospedaliero accreditato	Verona

Sponsors (7)

Lead Sponsor	Collaborator
Istituti Ospitalieri di Cremona	Arcispedale Santa Maria Nuova-IRCCS, Azienda Ospedaliero-Universitaria di Parma, Centro di Riferimento Oncologico - Aviano, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Istituto Di Ricerche Farmacologiche Mario Negri, Ospedale Sacro Cuore - Don Calabria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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