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

NCT ID: NCT03008993

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 762 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-17
• Study Completion Date: 2018-11-06

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Post-Intervention

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.

Group Type: EXPERIMENTAL

HQIS implementation

Intervention Type: BEHAVIORAL

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HQIS implementation

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria di Parma

OTHER

Sponsor Role: collaborator

Centro di Riferimento Oncologico - Aviano

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role: collaborator

Istituto Di Ricerche Farmacologiche Mario Negri

OTHER

Sponsor Role: collaborator

IRCCS Sacro Cuore Don Calabria di Negrar

OTHER

Sponsor Role: collaborator

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: collaborator

Istituti Ospitalieri di Cremona

OTHER

Sponsor Role: lead

Responsible Party

Rodolfo Passalacqua

Head of division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodolfo Passalacqua

Role: PRINCIPAL_INVESTIGATOR

Istituti Ospitalieri Cremona

Locations

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

Milan, , 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, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 34648011 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28988170 (View on PubMed)

Other Identifiers

HuCare2

Identifier Type: -

Identifier Source: org_study_id