The Effect of Case Management in Complex Cancer Pathways

Rectal Neoplasms Clinical Trial

Official title:

The Effect of Case Management in Complex Cancer Pathways

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845247
• Other study ID #: 477 980 567
• Secondary ID: Datatilsyn J.nr.
• Status: Completed
• Phase: N/A
• First received: February 13, 2009
• Last updated: August 30, 2012
• Start date: March 2009
• Est. completion date: January 2012

Study information

• Verified date: August 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colonic Neoplasms
• Neoplasms
• Rectal Neoplasms

Intervention

Other:
• Nurse case management
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.

Locations

Country	Name	City	State
Denmark	Department P, Aarhus University Hospital	Aarhus C

Sponsors (6)

Lead Sponsor	Collaborator
University of Aarhus	Forskningsrådet for Sundhed og Sygdom, Kræftens Bekæmpelse, Kvalitets- og efteruddannelsesudvalget for Region Midtjylland, Novo Nordisk A/S, Research Unit for General Practice, Aarhus University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction with care pathways(questionnaire)		8, 30 and 52 weeks after inclusion and randomization	No
Primary	Quality of Life measures(questionnaire)		8, 30 and 52 weeks after inclusion and randomization	No
Secondary	Use of health care services during "the secondary care treatment period", i.e. GPs, emergency department, planned and emergency admission, total length of hospitalisation		12 (and 6) months from diagnosis	No
Secondary	GPs' evaluations of continuity of care (questionnaire).		30 weeks after the patient's inclusion in the trial	No
Secondary	Care process measures in terms of monitoring of data from the National Patient Registry		12 (and 6) months after diagnosis	No