The Effect of Case Management in Complex Cancer Pathways

This study has been completed.
Sponsor:
Collaborators:
Research Unit for General Practice, Aarhus University
Forskningsrådet for Sundhed og Sygdom
Kræftens Bekæmpelse
Novo Nordisk A/S
Kvalitets- og efteruddannelsesudvalget for Region Midtjylland
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00845247
First received: February 13, 2009
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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.

Condition Intervention
Colonic Neoplasms
Rectal Neoplasms
Other: Nurse case management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: The Effect of Case Management in Complex Cancer Pathways

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Patient satisfaction with care pathways(questionnaire) [ Time Frame: 8, 30 and 52 weeks after inclusion and randomization ] [ Designated as safety issue: No ]
  • Quality of Life measures(questionnaire) [ Time Frame: 8, 30 and 52 weeks after inclusion and randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • GPs' evaluations of continuity of care (questionnaire). [ Time Frame: 30 weeks after the patient's inclusion in the trial ] [ Designated as safety issue: No ]
  • Care process measures in terms of monitoring of data from the National Patient Registry [ Time Frame: 12 (and 6) months after diagnosis ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: March 2009
Study Completion Date: January 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845247

Locations
Denmark
Department P, Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Research Unit for General Practice, Aarhus University
Forskningsrådet for Sundhed og Sygdom
Kræftens Bekæmpelse
Novo Nordisk A/S
Kvalitets- og efteruddannelsesudvalget for Region Midtjylland
Investigators
Principal Investigator: Christian N Wulff, MD Research Unit of General Practice, Odense
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00845247     History of Changes
Other Study ID Numbers: 477 980 567, Datatilsyn J.nr. 2008-41-2932
Study First Received: February 13, 2009
Last Updated: August 30, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: National Board of Health

Keywords provided by University of Aarhus:
Case Management

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases

ClinicalTrials.gov processed this record on October 19, 2014