The Effect of Case Management in Complex Cancer Pathways
NCT00845247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280
Last updated 2012-08-31
Summary
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.
Conditions
- Colonic Neoplasms
- Rectal Neoplasms
Interventions
- OTHER
-
Nurse case management
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
Sponsors & Collaborators
-
Research Unit for General Practice, Aarhus University
collaborator OTHER -
The Research Council for Health and Disease, Denmark
collaborator OTHER -
Danish Cancer Society
collaborator OTHER - collaborator INDUSTRY
-
Kvalitets- og efteruddannelsesudvalget for Region Midtjylland
collaborator UNKNOWN -
University of Aarhus
lead OTHER
Principal Investigators
-
Christian N Wulff, MD · Research Unit of General Practice, Odense
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-03-31
- Primary Completion
- 2011-01-31
- Completion
- 2012-01-31
Countries
- Denmark
Study Locations
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