The Effect of Case Management in Complex Cancer Pathways

August 30, 2012 updated by: University of Aarhus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Department P, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction with care pathways(questionnaire)
Time Frame: 8, 30 and 52 weeks after inclusion and randomization
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
8, 30 and 52 weeks after inclusion and randomization

Secondary Outcome Measures

Outcome 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
Time Frame: 12 (and 6) months from diagnosis
12 (and 6) months from diagnosis
GPs' evaluations of continuity of care (questionnaire).
Time Frame: 30 weeks after the patient's inclusion in the trial
30 weeks after the patient's inclusion in the trial
Care process measures in terms of monitoring of data from the National Patient Registry
Time Frame: 12 (and 6) months after diagnosis
12 (and 6) months after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Novo Nordisk A/S
Danish Cancer Society
Research Unit for General Practice, Aarhus University
The Research Council for Health and Disease, Denmark
Kvalitets- og efteruddannelsesudvalget for Region Midtjylland

Investigators

  • Principal Investigator: Christian N Wulff, MD, Research Unit of General Practice, Odense

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

August 31, 2012

Last Update Submitted That Met QC Criteria

August 30, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 477 980 567
  • Datatilsyn J.nr. 2008-41-2932

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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