- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Aarhus C, Danmark, 8000
- Department P, Aarhus University Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: Control
Control group patients will receive usual medical plus usual supportive treatment.
|
|
Aktiv komparator: Case management
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
|
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Patient satisfaction with care pathways(questionnaire)
Tidsram: 8, 30 and 52 weeks after inclusion and randomization
|
8, 30 and 52 weeks after inclusion and randomization
|
Quality of Life measures(questionnaire)
Tidsram: 8, 30 and 52 weeks after inclusion and randomization
|
8, 30 and 52 weeks after inclusion and randomization
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Use of health care services during "the secondary care treatment period", i.e. GPs, emergency department, planned and emergency admission, total length of hospitalisation
Tidsram: 12 (and 6) months from diagnosis
|
12 (and 6) months from diagnosis
|
GPs' evaluations of continuity of care (questionnaire).
Tidsram: 30 weeks after the patient's inclusion in the trial
|
30 weeks after the patient's inclusion in the trial
|
Care process measures in terms of monitoring of data from the National Patient Registry
Tidsram: 12 (and 6) months after diagnosis
|
12 (and 6) months after diagnosis
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Christian N Wulff, MD, Research Unit of General Practice, Odense
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 477 980 567
- Datatilsyn J.nr. 2008-41-2932
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