The Effect of Case Management in Complex Cancer Pathways

University of Aarhus

Status: Completed

Conditions: Colonic Neoplasms; Rectal Neoplasms

Treatments: Other: Nurse case management

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00845247

Datatilsyn J.nr. 2008-41-2932

477 980 567

Details and patient eligibility

About

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.

Enrollment: 280 patients

Sex: All

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Control group patients will receive usual medical plus usual supportive treatment.

Case management

Active Comparator group

Description:

Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.

Treatment:

Other: Nurse case management