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The Effect of Case Management in Complex Cancer Pathways

Primary Purpose

Colonic Neoplasms, Rectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Nurse case management
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colonic Neoplasms focused on measuring Case Management

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Department P, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Case management

Arm Description

Control group patients will receive usual medical plus usual supportive treatment.

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

Outcomes

Primary Outcome Measures

Patient satisfaction with care pathways(questionnaire)
Quality of Life measures(questionnaire)

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
GPs' evaluations of continuity of care (questionnaire).
Care process measures in terms of monitoring of data from the National Patient Registry

Full Information

First Posted
February 13, 2009
Last Updated
August 30, 2012
Sponsor
University of Aarhus
Collaborators
Research Unit for General Practice, Aarhus University, The Research Council for Health and Disease, Denmark, Danish Cancer Society, Novo Nordisk A/S, Kvalitets- og efteruddannelsesudvalget for Region Midtjylland
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1. Study Identification

Unique Protocol Identification Number
NCT00845247
Brief Title
The Effect of Case Management in Complex Cancer Pathways
Official Title
The Effect of Case Management in Complex Cancer Pathways
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Research Unit for General Practice, Aarhus University, The Research Council for Health and Disease, Denmark, Danish Cancer Society, Novo Nordisk A/S, Kvalitets- og efteruddannelsesudvalget for Region Midtjylland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms, Rectal Neoplasms
Keywords
Case Management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control group patients will receive usual medical plus usual supportive treatment.
Arm Title
Case management
Arm Type
Active Comparator
Arm Description
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
Intervention Type
Other
Intervention Name(s)
Nurse case management
Intervention Description
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
Primary Outcome Measure Information:
Title
Patient satisfaction with care pathways(questionnaire)
Time Frame
8, 30 and 52 weeks after inclusion and randomization
Title
Quality of Life measures(questionnaire)
Time Frame
8, 30 and 52 weeks after inclusion and randomization
Secondary Outcome Measure Information:
Title
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
Title
GPs' evaluations of continuity of care (questionnaire).
Time Frame
30 weeks after the patient's inclusion in the trial
Title
Care process measures in terms of monitoring of data from the National Patient Registry
Time Frame
12 (and 6) months after diagnosis

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian N Wulff, MD
Organizational Affiliation
Research Unit of General Practice, Odense
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department P, Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23175735
Citation
Wulff CN, Vedsted P, Sondergaard J. A randomised controlled trial of hospital-based case management to improve colorectal cancer patients' health-related quality of life and evaluations of care. BMJ Open. 2012 Nov 21;2(6):e001481. doi: 10.1136/bmjopen-2012-001481. Print 2012.
Results Reference
derived

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The Effect of Case Management in Complex Cancer Pathways

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