Clinical trial NCT03008993: A Stepped Wedge Cluster Randomized Controlled Trial to Assess a Strategy Aiming to Optimize Psychosocial Outcomes in Patients With Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Istituti Ospitalieri di Cremona
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero-Universitaria di Parma
name: Centro di Riferimento Oncologico - Aviano
name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Istituto Di Ricerche Farmacologiche Mario Negri
name: IRCCS Sacro Cuore Don Calabria di Negrar
name: Azienda USL Reggio Emilia - IRCCS
First posted: 2017-01-04
Enrollment: 762
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) -C30
timeFrame: baseline - 3rd month
Secondary outcomes:
Other outcomes:
Locations:
city: Brindisi
country: Italy
facility: Azienda USL- Presidio "Di Summa - Perrino"
city: Cosenza
country: Italy
facility: Azienda Ospedaliera di Cosenza
city: Fano
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Universitario "G.Martino"
city: Milano
country: Italy
facility: IRCCS Istituto Tumori
city: Napoli
country: Italy
facility: Azienda Ospedaliera dei Colli
city: Nuoro
country: Italy
facility: Azienda Sanitaria Locale
city: Palermo
country: Italy
facility: Azienda Ospedaliera "P Giaccone"
city: Pesaro
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord
city: Sassari
country: Italy
facility: ASL Ospedale SS Annunziata
city: Torino
country: Italy
facility: Azienda Ospedaliero Universitaria "San Luigi Gonzaga"
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza
city: Trapani
country: Italy
facility: Azienda Ospedaliera Sanitaria Provinciale
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria di Udine
city: Verona
country: Italy
facility: Ospedale Sacro Cuore "Don Calabria" Presidio ospedaliero accreditato
Study officials:
affiliation: Istituti Ospitalieri Cremona
name: Rodolfo Passalacqua
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caminiti C, Annunziata MA, Verusio C, Pinto C, Airoldi M, Aragona M, Caputo F, Cinieri S, Giordani P, Gori S, Mattioli R, Novello S, Pazzola A, Procopio G, Russo A, Sarobba G, Zerilli F, Diodati F, Iezzi E, Maglietta G, Passalacqua R. Effectiveness of a Psychosocial Care Quality Improvement Strategy to Address Quality of Life in Patients With Cancer: The HuCare2 Stepped-Wedge Cluster Randomized Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2128667. doi: 10.1001/jamanetworkopen.2021.28667.
citation: Caminiti C, Iezzi E, Passalacqua R. Effectiveness of the HuCare Quality Improvement Strategy on health-related quality of life in patients with cancer: study protocol of a stepped-wedge cluster randomised controlled trial (HuCare2 study). BMJ Open. 2017 Oct 6;7(10):e016347. doi: 10.1136/bmjopen-2017-016347.