The Effect of Case Management in Complex Cancer Pathways
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Patient satisfaction with care pathways(questionnaire)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colon or rectal cancer are highly suspected and a course of treatment at Department P, Aarhus University Hospital is expected to follow.
排除标准
- •Do not speak and understand Danish sufficiently to fill out questionnaires (due to dementia, some foreigners etc.)
研究组 & 干预措施
Control
Control group patients will receive usual medical plus usual supportive treatment.
Case management
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
干预措施: Nurse case management (Other)
结局指标
主要结局
Patient satisfaction with care pathways(questionnaire)
时间窗: 8, 30 and 52 weeks after inclusion and randomization
Quality of Life measures(questionnaire)
时间窗: 8, 30 and 52 weeks after inclusion and randomization
次要结局
- 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)