- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02205853
Implementation of Physical Cancer Rehabilitation Programmes in a European Healthcare System.
An Evaluation of a Patient-directed Strategy Compared With a Multi-faceted Strategy to Implement Physical Cancer Rehabilitation Programmes; a Controlled Before and After Study.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
The aim of this study is to develop and identify the most effective strategy to implement PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared with a single-faceted patient-directed strategy.
We will conduct a clustered controlled before and after study (CBA) in the Netherlands that compares two strategies to implement PCRPs. The patient-directed (PD) strategy (five hospitals) will focus on change at the patient level. The multi-faceted (MF) strategy (five hospitals) will focus on change at the patient, professional and organizational levels. Eligibility criteria are as follows: (A) patients: adults; preferably (history of) cancer in the gastro-intestinal, reproductive and/or urological system; successful primary treatment; and without recurrence/metastases. (B) Healthcare professionals: involved in cancer care.
A stepwise approach will be followed:
Step 1: Analysis of the current implementation of PCRPs and the examination of barriers and facilitators for implementation, via a qualitative study with patients (four focus groups n = 10-12) and their healthcare workers (four focus groups n = 10-12 and individual interviews n = 30-40) and collecting data on adherence to quality indicators (n = 500 patients, 50 per hospital).
Step 2: Selection and development of interventions to create a PD and MF strategy during expert's roundtable discussions, using the knowledge gained in step 1 and a literature search of the effect of strategies for implementing PCRPs.
Step 3: Test and compare both strategies with a clustered CBA (effectiveness, process evaluation and costs), by data extraction from existing registration systems, questionnaires and interviews. For the effectiveness and cost-effectiveness, n = 500 patients, 50 per hospital. For the process evaluation, n=50 patients, 5 per hospital, and n = 40 healthcare professionals, 4 per hospital.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Gelderland
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Nijmegen, Gelderland, Holandsko, 6500HB
- Nábor
- Radboud University Nijmegen Medical Center
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Kontakt:
- C. IJsbrandy, drs.
- E-mail: charlotte.ijsbrandy@radboudumc.nl
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
patients:
- preferably (history of) cancer in the gastro-intestinal, reproductive and/or urological system; successful primary treatment; and without recurrence/metastases.
- Adults
- Diagnosed in one of the participating hospitals
- Able to read and understand Dutch
Healthcare professionals:
• involved in cancer care in one of the participating hospitals
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: The patient-directed (PD) strategy
A single-faceted patient-directed (PD) strategy that will embed the change at patient level.
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The patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients.
|
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Jiný: The multi-faceted (MF) strategy
A multi-faceted (MF) strategy that will embed the change at the patient, professional and organizational levels.
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The multi-faceted strategy will be designed to embed the success by not only influencing the patients, but also professionals and organizational aspects.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.
Časové okno: baseline and at follow-up
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A pre- and post measurement of 'the percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'' will be done.
The differences between the pre- and post measurement will be measured.
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baseline and at follow-up
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The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'.
Časové okno: baseline and at follow-up
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A pre- and post measurement of 'The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'' will be done.
The differences between the pre- and post measurement will be measured.
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baseline and at follow-up
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Quality of life
Časové okno: baseline and at follow-up
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A pre- and post measurement of 'QoL' will be done.
The differences between the pre- and post measurement will be measured.
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baseline and at follow-up
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Patientempowerment
Časové okno: baseline and at follow-up
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A pre- and post measurement of 'patientempowerment' will be done.
The differences between the pre- and post measurement will be measured.
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baseline and at follow-up
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Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'.
Časové okno: baseline and at follow-up
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A pre- and post measurement of ' the Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'' will be done.
The differences between the pre- and post measurement will be measured.
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baseline and at follow-up
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Process-evaluation
Časové okno: at follow-up
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The experiences and exposure of patients and professionals with the PD- and MF strategy will be evaluated by interviews.
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at follow-up
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Cost
Časové okno: at follow-up
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incremental costs and incremental cost-effectiveness ratios (ICERs)
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at follow-up
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: C. IJsbrandy, MD, Radboud Univeristy Medical Centre Nijmegen
- Studijní židle: R.P.M.G. Hermens, PhD, Radboud Univeristy Medical Centre Nijmegen
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Primární dokončení (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NKI 2010-4854
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Klinické studie na The patient-directed (PD) strategy
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