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

NCT03008993 | Completed

• 1 other identifier: HuCare2
• Study Type: interventional
• Target: 762
• Locations: 1 country
• Sites: 15

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Post-Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Interventions

HQIS implementation BEHAVIORAL

Post-Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituti Ospitalieri di Cremona: lead
• Azienda Ospedaliero-Universitaria di Parma: collaborator
• Centro di Riferimento Oncologico - Aviano: collaborator
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: collaborator
• Istituto Di Ricerche Farmacologiche Mario Negri: collaborator
• IRCCS Sacro Cuore Don Calabria di Negrar: collaborator
• Azienda USL Reggio Emilia - IRCCS: collaborator

Study Sites (15)

Azienda USL- Presidio "Di Summa - Perrino"

Brindisi, Italy

Location

Azienda Ospedaliera di Cosenza

Cosenza, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Fano, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Universitario "G.Martino"

Messina, Italy

Location

IRCCS Istituto Tumori

Milan, Italy

Location

Azienda Ospedaliera dei Colli

Napoli, Italy

Location

Azienda Sanitaria Locale

Nuoro, Italy

Location

Azienda Ospedaliera "P Giaccone"

Palermo, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, Italy

Location

ASL Ospedale SS Annunziata

Sassari, Italy

Location

Azienda Ospedaliero Universitaria "San Luigi Gonzaga"

Torino, Italy

Location

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza

Torino, Italy

Location

Azienda Ospedaliera Sanitaria Provinciale

Trapani, Italy

Location

Azienda Ospedaliero-Universitaria di Udine

Udine, Italy

Location

Ospedale Sacro Cuore "Don Calabria" Presidio ospedaliero accreditato

Verona, Italy

Location

Related Publications (2)

• 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.

  PMID: 34648011 DERIVED

• 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.

  PMID: 28988170 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Rodolfo Passalacqua

  Istituti Ospitalieri Cremona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of division

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: January 4, 2017
• Study Start: October 17, 2016
• Primary Completion: November 6, 2018
• Study Completion: November 6, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

IT (15)