- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00845247
The Effect of Case Management in Complex Cancer Pathways
Introduction: Case management (CM) has been proposed as a method for optimizing the course of treatment for complicated cancer patients. However evidence of the effect of CM is limited and methodologically rigorous research is needed.
Aim: To analyze effects of Nurse CM in complicated cancer care.
Methods: The study is designed as a two-arm randomized controlled trial (RCT) including approximately 280 colorectal cancer patients.
Intervention group patients will be offered usual medical treatment plus supportive intervention from a case manager. Control group patients will receive usual medical and supportive treatment.
The intervention: Case managers are registered nurses and possess thorough knowledge of cancer treatment and pathways. Core intervention elements: Planned and ad hoc personal and telephone contacts, surveillance of care pathways, coordination and dissemination of care plan (including transfer of patient-specific information to other departments and general practice).
Primary outcomes: Patient evaluations of care pathways and "Quality of Life" (questionnaires).
Secondary outcomes: Use of health care services and care process measures (The National Health Insurance Service Registry and The National Patient Registry; and GPs' evaluations of continuity of care (questionnaire).
Schedule:
- "Case management used to optimize cancer care pathways: A systematic Review" has been published in BMC Health Services Research.
- The CM manual has been written. Questionnaires are under development and pilot testing.
- Two case managers have been appointed 1. January 2009.
- After training and pilot testing of the intervention the RCT will begin in March 2009. Inclusion period is 12 months.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Aarhus C, Danmark, 8000
- Department P, Aarhus University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Colon or rectal cancer are highly suspected and a course of treatment at Department P, Aarhus University Hospital is expected to follow.
Exclusion Criteria:
- Do not speak and understand Danish sufficiently to fill out questionnaires (due to dementia, some foreigners etc.)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: Control
Control group patients will receive usual medical plus usual supportive treatment.
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Aktiv komparator: Case management
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
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Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Patient satisfaction with care pathways(questionnaire)
Tidsramme: 8, 30 and 52 weeks after inclusion and randomization
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8, 30 and 52 weeks after inclusion and randomization
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Quality of Life measures(questionnaire)
Tidsramme: 8, 30 and 52 weeks after inclusion and randomization
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8, 30 and 52 weeks after inclusion and randomization
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Use of health care services during "the secondary care treatment period", i.e. GPs, emergency department, planned and emergency admission, total length of hospitalisation
Tidsramme: 12 (and 6) months from diagnosis
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12 (and 6) months from diagnosis
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GPs' evaluations of continuity of care (questionnaire).
Tidsramme: 30 weeks after the patient's inclusion in the trial
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30 weeks after the patient's inclusion in the trial
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Care process measures in terms of monitoring of data from the National Patient Registry
Tidsramme: 12 (and 6) months after diagnosis
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12 (and 6) months after diagnosis
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Christian N Wulff, MD, Research Unit of General Practice, Odense
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 477 980 567
- Datatilsyn J.nr. 2008-41-2932
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