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

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ClinicalTrials.gov Identifier: NCT03008993
Recruitment Status : Active, not recruiting
First Posted : January 4, 2017
Last Update Posted : August 23, 2018
Sponsor:
Collaborators:
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
Arcispedale Santa Maria Nuova-IRCCS
Information provided by (Responsible Party):
Rodolfo Passalacqua, Istituti Ospitalieri di Cremona

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.


Condition or disease Intervention/treatment Phase
Cancer Behavioral: HQIS implementation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : October 17, 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
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
No Intervention: Control



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008993


Locations
Italy
Azienda USL- Presidio "Di Summa - Perrino"
Brindisi, Italy
Azienda Ospedaliera Molise - Presidio Ospedaliero Cardarelli
Campobasso, 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
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
Sponsors and Collaborators
Istituti Ospitalieri di Cremona
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
Arcispedale Santa Maria Nuova-IRCCS
Investigators
Principal Investigator: Rodolfo Passalacqua Istituti Ospitalieri Cremona

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rodolfo Passalacqua, Head of division, Istituti Ospitalieri di Cremona
ClinicalTrials.gov Identifier: NCT03008993     History of Changes
Other Study ID Numbers: HuCare2
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018