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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Aarhus C, Danemark, 8000
- Department P, Aarhus University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: Control
Control group patients will receive usual medical plus usual supportive treatment.
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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Patient satisfaction with care pathways(questionnaire)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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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
Délai: 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).
Délai: 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
Délai: 12 (and 6) months after diagnosis
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12 (and 6) months after diagnosis
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Christian N Wulff, MD, Research Unit of General Practice, Odense
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 477 980 567
- Datatilsyn J.nr. 2008-41-2932
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