The Effect of Case Management in Complex Cancer Pathways
NCT ID: NCT00845247
Last Updated: 2012-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
280 participants
INTERVENTIONAL
2009-03-31
2012-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Control
Control group patients will receive usual medical plus usual supportive treatment.
No interventions assigned to this group
Case management
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
Nurse case management
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
Interventions
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Nurse case management
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Research Unit for General Practice, Aarhus University
OTHER
The Research Council for Health and Disease, Denmark
OTHER
Danish Cancer Society
OTHER
Novo Nordisk A/S
INDUSTRY
Kvalitets- og efteruddannelsesudvalget for Region Midtjylland
UNKNOWN
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Christian N Wulff, MD
Role: PRINCIPAL_INVESTIGATOR
Research Unit of General Practice, Odense
Locations
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Department P, Aarhus University Hospital
Aarhus C, , Denmark
Countries
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References
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Wulff CN, Vedsted P, Sondergaard J. A randomised controlled trial of hospital-based case management to improve colorectal cancer patients' health-related quality of life and evaluations of care. BMJ Open. 2012 Nov 21;2(6):e001481. doi: 10.1136/bmjopen-2012-001481. Print 2012.
Other Identifiers
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Datatilsyn J.nr. 2008-41-2932
Identifier Type: -
Identifier Source: secondary_id
477 980 567
Identifier Type: -
Identifier Source: org_study_id