The Effect of Case Management in Complex Cancer Pathways

NCT00845247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2012-08-31

No results posted yet for this study

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.

Conditions

  • Colonic Neoplasms
  • Rectal Neoplasms

Interventions

OTHER

Nurse case management

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

Sponsors & Collaborators

  • Research Unit for General Practice, Aarhus University

    collaborator OTHER
  • The Research Council for Health and Disease, Denmark

    collaborator OTHER
  • Danish Cancer Society

    collaborator OTHER
  • Novo Nordisk A/S

    collaborator INDUSTRY
  • Kvalitets- og efteruddannelsesudvalget for Region Midtjylland

    collaborator UNKNOWN
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Christian N Wulff, MD · Research Unit of General Practice, Odense

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-01-31
Completion
2012-01-31

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00845247 on ClinicalTrials.gov