Colonic Neoplasms, Rectal Neoplasms
Conditions
Keywords
Case Management
Brief 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.
Interventions
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
Sponsors
Research Unit for General Practice, Aarhus University
The Research Council for Health and Disease, Denmark
Danish Cancer Society
Novo Nordisk A/S
Kvalitets- og efteruddannelsesudvalget for Region Midtjylland
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient satisfaction with care pathways(questionnaire) | 8, 30 and 52 weeks after inclusion and randomization |
| Quality of Life measures(questionnaire) | 8, 30 and 52 weeks after inclusion and randomization |
Secondary
| Measure | Time frame |
|---|---|
| Use of health care services during the secondary care treatment period, i.e. GPs, emergency department, planned and emergency admission, total length of hospitalisation | 12 (and 6) months from diagnosis |
| GPs' evaluations of continuity of care (questionnaire). | 30 weeks after the patient's inclusion in the trial |
| Care process measures in terms of monitoring of data from the National Patient Registry | 12 (and 6) months after diagnosis |
Countries
Denmark
Outcome results
None listed