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| ID | Type | Description | Link |
|---|---|---|---|
| Datatilsyn J.nr. 2008-41-2932 |
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| Name | Class |
|---|---|
| Research Unit for General Practice, Aarhus University | OTHER |
| The Research Council for Health and Disease, Denmark | OTHER |
| Danish Cancer Society | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Control group patients will receive usual medical plus usual supportive treatment. | |
| Case management | Active Comparator | Intervention group patients are offered the support of a nurse case manager throughout their course of treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse case management | Other | Intervention group patients are offered the support of a nurse case manager throughout their course of treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with care pathways(questionnaire) | 8, 30 and 52 weeks after inclusion and randomization | |
| Quality of Life measures(questionnaire) | 8, 30 and 52 weeks after inclusion and randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian N Wulff, MD | Research Unit of General Practice, Odense | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department P, Aarhus University Hospital | Aarhus C | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23175735 | Derived | 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. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Novo Nordisk A/S |
| INDUSTRY |
| Kvalitets- og efteruddannelsesudvalget for Region Midtjylland | UNKNOWN |
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| 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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |