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 |
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Recruitment Status :
Active, not recruiting
First Posted : January 4, 2017
Last Update Posted : August 23, 2018
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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 |
|---|---|
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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.
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Behavioral: HQIS implementation |
| No Intervention: Control |
- 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 |
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
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
| 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 | |
| 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 |