Clinical trial NCT00845247: The Effect of Case Management in Complex Cancer Pathways
Official title: The Effect of Case Management in Complex Cancer Pathways
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Neoplasms
Rectal Neoplasms
Keywords: Case Management
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Research Unit for General Practice, Aarhus University
name: The Research Council for Health and Disease, Denmark
name: Danish Cancer Society
name: Novo Nordisk A/S
name: Kvalitets- og efteruddannelsesudvalget for Region Midtjylland
First posted: 2009-02-18
Enrollment: 280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.)

Primary outcomes:
measure: Patient satisfaction with care pathways(questionnaire)
timeFrame: 8, 30 and 52 weeks after inclusion and randomization
measure: Quality of Life measures(questionnaire)
timeFrame: 8, 30 and 52 weeks after inclusion and randomization
Secondary outcomes:
measure: Use of health care services during "the secondary care treatment period", i.e. GPs, emergency department, planned and emergency admission, total length of hospitalisation
timeFrame: 12 (and 6) months from diagnosis
measure: GPs' evaluations of continuity of care (questionnaire).
timeFrame: 30 weeks after the patient's inclusion in the trial
measure: Care process measures in terms of monitoring of data from the National Patient Registry
timeFrame: 12 (and 6) months after diagnosis
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department P, Aarhus University Hospital
Study officials:
affiliation: Research Unit of General Practice, Odense
name: Christian N Wulff, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.