The Effect of Case Management in Complex Cancer Pathways

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Case Management in Complex Cancer Pathways

Conditions
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Colonic Neoplasms, Rectal Neoplasms

Intervention / Treatment
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* Other: Nurse case management


Participation Criteria
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Eligibility Criteria
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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.)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Control group patients will receive usual medical plus usual supportive treatment. | |
| Active Comparator: Case management<br>Intervention group patients are offered the support of a nurse case manager throughout their course of treatment. | Other: Nurse case management<br>* Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Case Management