The Effect of Case Management in Complex Cancer Pathways
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colonic Neoplasms Rectal Neoplasms |
Other: Nurse case management |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Health Services Research |
| Official Title: | The Effect of Case Management in Complex Cancer Pathways |
- Patient satisfaction with care pathways(questionnaire) [ Time Frame: 8, 30 and 52 weeks after inclusion and randomization ] [ Designated as safety issue: No ]
- Quality of Life measures(questionnaire) [ Time Frame: 8, 30 and 52 weeks after inclusion and randomization ] [ Designated as safety issue: No ]
- Use of health care services during "the secondary care treatment period", i.e. GPs, emergency department, planned and emergency admission, total length of hospitalisation [ Time Frame: 12 (and 6) months from diagnosis ] [ Designated as safety issue: No ]
- GPs' evaluations of continuity of care (questionnaire). [ Time Frame: 30 weeks after the patient's inclusion in the trial ] [ Designated as safety issue: No ]
- Care process measures in terms of monitoring of data from the National Patient Registry [ Time Frame: 12 (and 6) months after diagnosis ] [ Designated as safety issue: No ]
| Enrollment: | 280 |
| Study Start Date: | March 2009 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Control
Control group patients will receive usual medical plus usual supportive treatment.
|
|
|
Active Comparator: Case management
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
|
Other: Nurse case management
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.)
Contacts and Locations| Denmark | |
| Department P, Aarhus University Hospital | |
| Aarhus C, Denmark, 8000 | |
| Principal Investigator: | Christian N Wulff, MD | Research Unit of General Practice, Odense |
More Information
No publications provided
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00845247 History of Changes |
| Other Study ID Numbers: | 477 980 567, Datatilsyn J.nr. 2008-41-2932 |
| Study First Received: | February 13, 2009 |
| Last Updated: | August 30, 2012 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: National Board of Health |
Keywords provided by University of Aarhus:
|
Case Management |
Additional relevant MeSH terms:
|
Neoplasms Colonic Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013