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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Aarhus C、デンマーク、8000
- Department P, Aarhus University Hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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.)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Control
Control group patients will receive usual medical plus usual supportive treatment.
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|
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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Patient satisfaction with care pathways(questionnaire)
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Use of health care services during "the secondary care treatment period", i.e. GPs, emergency department, planned and emergency admission, total length of hospitalisation
時間枠：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).
時間枠：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
時間枠：12 (and 6) months after diagnosis
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12 (and 6) months after diagnosis
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Christian N Wulff, MD、Research Unit of General Practice, Odense
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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