The Effect of Case Management in Complex Cancer Pathways
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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Aarhus C, 덴마크, 8000
- Department P, Aarhus University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: Control
Control group patients will receive usual medical plus usual supportive treatment.
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활성 비교기: Case management
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
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Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Patient satisfaction with care pathways(questionnaire)
기간: 8, 30 and 52 weeks after inclusion and randomization
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8, 30 and 52 weeks after inclusion and randomization
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Quality of Life measures(questionnaire)
기간: 8, 30 and 52 weeks after inclusion and randomization
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8, 30 and 52 weeks after inclusion and randomization
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2차 결과 측정
결과 측정 |
기간 |
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Use of health care services during "the secondary care treatment period", i.e. GPs, emergency department, planned and emergency admission, total length of hospitalisation
기간: 12 (and 6) months from diagnosis
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12 (and 6) months from diagnosis
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GPs' evaluations of continuity of care (questionnaire).
기간: 30 weeks after the patient's inclusion in the trial
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30 weeks after the patient's inclusion in the trial
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Care process measures in terms of monitoring of data from the National Patient Registry
기간: 12 (and 6) months after diagnosis
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12 (and 6) months after diagnosis
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Christian N Wulff, MD, Research Unit of General Practice, Odense
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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