- ICH GCP
- US-Register für klinische Studien
- Klinische 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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Gelderland
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Nijmegen, Gelderland, Niederlande, 6500HB
- Rekrutierung
- Radboud University Nijmegen Medical Center
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Kontakt:
- C. IJsbrandy, drs.
- E-Mail: charlotte.ijsbrandy@radboudumc.nl
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: 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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Sonstiges: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.
Zeitfenster: 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'.
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Quality of life
Zeitfenster: 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
Zeitfenster: 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'.
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Process-evaluation
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: C. IJsbrandy, MD, Radboud Univeristy Medical Centre Nijmegen
- Studienstuhl: R.P.M.G. Hermens, PhD, Radboud Univeristy Medical Centre Nijmegen
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Primärer Abschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NKI 2010-4854
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