NCT00845247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

August 31, 2012

Status Verified

August 1, 2012

Enrollment Period

1.8 years

First QC Date

February 13, 2009

Last Update Submit

August 30, 2012

Conditions

Colonic NeoplasmsRectal Neoplasms

Keywords

Case Management

Outcome Measures

Primary Outcomes (2)

  • Patient satisfaction with care pathways(questionnaire)

    8, 30 and 52 weeks after inclusion and randomization

  • Quality of Life measures(questionnaire)

    8, 30 and 52 weeks after inclusion and randomization

Secondary Outcomes (3)

  • 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

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

    30 weeks after the patient's inclusion in the trial

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

    12 (and 6) months after diagnosis

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Case management

ACTIVE COMPARATOR

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

Other: Nurse case management

Interventions

Nurse case managementOTHER

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

Case management

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Colon or rectal cancer are highly suspected and a course of treatment at Department P, Aarhus University Hospital is expected to follow.

You may not qualify if:

  • Do not speak and understand Danish sufficiently to fill out questionnaires (due to dementia, some foreigners etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department P, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 23175735DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Christian N Wulff, MD

    Research Unit of General Practice, Odense

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2009

First Posted

February 18, 2009

Study Start

March 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2012

Last Updated

August 31, 2012

Record last verified: 2012-08

Locations

DK(1)