- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Gelderland
-
Nijmegen, Gelderland, Nederland, 6500HB
- Rekruttering
- Radboud University Nijmegen Medical Center
-
Ta kontakt med:
- C. IJsbrandy, drs.
- E-post: charlotte.ijsbrandy@radboudumc.nl
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: The patient-directed (PD) strategy
A single-faceted patient-directed (PD) strategy that will embed the change at patient level.
|
The patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients.
|
|
Annen: The multi-faceted (MF) strategy
A multi-faceted (MF) strategy that will embed the change at the patient, professional and organizational levels.
|
The multi-faceted strategy will be designed to embed the success by not only influencing the patients, but also professionals and organizational aspects.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.
Tidsramme: baseline and at follow-up
|
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.
|
baseline and at follow-up
|
|
The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'.
Tidsramme: baseline and at follow-up
|
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.
|
baseline and at follow-up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of life
Tidsramme: baseline and at follow-up
|
A pre- and post measurement of 'QoL' will be done.
The differences between the pre- and post measurement will be measured.
|
baseline and at follow-up
|
|
Patientempowerment
Tidsramme: baseline and at follow-up
|
A pre- and post measurement of 'patientempowerment' will be done.
The differences between the pre- and post measurement will be measured.
|
baseline and at follow-up
|
|
Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'.
Tidsramme: baseline and at follow-up
|
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.
|
baseline and at follow-up
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Process-evaluation
Tidsramme: at follow-up
|
The experiences and exposure of patients and professionals with the PD- and MF strategy will be evaluated by interviews.
|
at follow-up
|
|
Cost
Tidsramme: at follow-up
|
incremental costs and incremental cost-effectiveness ratios (ICERs)
|
at follow-up
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: C. IJsbrandy, MD, Radboud Univeristy Medical Centre Nijmegen
- Studiestol: R.P.M.G. Hermens, PhD, Radboud Univeristy Medical Centre Nijmegen
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Primær fullføring (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NKI 2010-4854
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