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Clinical Trials/NCT00845247
NCT00845247
Completed
Not Applicable

The Effect of Case Management in Complex Cancer Pathways

University of Aarhus1 site in 1 country280 target enrollmentMarch 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colonic Neoplasms
Sponsor
University of Aarhus
Enrollment
280
Locations
1
Primary Endpoint
Patient satisfaction with care pathways(questionnaire)
Status
Completed
Last Updated
13 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
March 2009
End Date
January 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.)

Outcomes

Primary Outcomes

Patient satisfaction with care pathways(questionnaire)

Time Frame: 8, 30 and 52 weeks after inclusion and randomization

Quality of Life measures(questionnaire)

Time Frame: 8, 30 and 52 weeks after inclusion and randomization

Secondary Outcomes

  • 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)

Study Sites (1)

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