A Stepped Wedge Cluster Randomized Controlled Trial to Assess a Strategy Aiming to Optimize Psychosocial Outcomes in Patients With Cancer (HuCare2)

February 25, 2019 updated by: Rodolfo Passalacqua, Istituti Ospitalieri di Cremona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

762

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brindisi, Italy
        • Azienda USL- Presidio "Di Summa - Perrino"
      • Cosenza, Italy
        • Azienda Ospedaliera di Cosenza
      • Fano, Italy
        • Azienda Ospedaliera Ospedali Riuniti Marche Nord
      • Messina, Italy
        • Azienda Ospedaliera Universitaria Policlinico Universitario "G.Martino"
      • Milano, Italy
        • IRCCS Istituto Tumori
      • Napoli, Italy
        • Azienda Ospedaliera Dei Colli
      • Nuoro, Italy
        • Azienda Sanitaria Locale
      • Palermo, Italy
        • Azienda Ospedaliera "P Giaccone"
      • Pesaro, Italy
        • Azienda Ospedaliera Ospedali Riuniti Marche Nord
      • Sassari, Italy
        • ASL Ospedale SS Annunziata
      • Torino, Italy
        • Azienda Ospedaliero Universitaria "San Luigi Gonzaga"
      • Torino, Italy
        • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza
      • Trapani, Italy
        • Azienda Ospedaliera Sanitaria Provinciale
      • Udine, Italy
        • Azienda Ospedaliero-Universitaria Di Udine
      • Verona, Italy
        • Ospedale Sacro Cuore "Don Calabria" Presidio ospedaliero accreditato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: 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.
Behavioral: HQIS implementation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Ospitalieri di Cremona

Collaborators

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Centro di Riferimento Oncologico - Aviano
Istituto Di Ricerche Farmacologiche Mario Negri
Azienda Ospedaliero-Universitaria di Parma
Arcispedale Santa Maria Nuova-IRCCS
IRCCS Sacro Cuore Don Calabria di Negrar

Investigators

  • Principal Investigator: Rodolfo Passalacqua, Istituti Ospitalieri Cremona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2016

Primary Completion (Actual)

November 6, 2018

Study Completion (Actual)

November 6, 2018

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • HuCare2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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