Clinical trial · Interventional
The Effect of Case Management in Complex Cancer Pathways
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nurse case management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Control group patients will receive usual medical plus usual supportive treatment.
- type
- ACTIVE_COMPARATOR
- label
- Case management
- description
- Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
- interventionNames
- Other: Nurse case management
Primary outcomes (2)
- measure
- Patient satisfaction with care pathways(questionnaire)
- timeFrame
- 8, 30 and 52 weeks after inclusion and randomization
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.)
References
Publications (1)
- DERIVEDWulff 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 23175735