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Completed

NCT Number: NCT00845247

The Effect of Case Management in Complex Cancer Pathways

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.

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Key information

Conditions

Colonic Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department P, Aarhus University Hospital

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Nurse case management

Other

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

Primary outcomes

  1. Patient satisfaction with care pathways(questionnaire)

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

  2. Quality of Life measures(questionnaire)

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

Secondary outcomes

  1. 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

  2. GPs' evaluations of continuity of care (questionnaire).

    Time frame: 30 weeks after the patient's inclusion in the trial

  3. Care process measures in terms of monitoring of data from the National Patient Registry

    Time frame: 12 (and 6) months after diagnosis

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

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

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Feb 18, 2009
Registry last updated
Aug 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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