Colonic NeoplasmsNCT00845247
The Effect of Case Management in Complex Cancer Pathways
A study testing Nurse case management in people with Colonic Neoplasms and Rectal Neoplasms, run by University of Aarhus at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colonic Neoplasms, Rectal Neoplasms
- What is being tested?
- Nurse case management
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Colon or rectal cancer are highly suspected and a course of treatment at Department P, Aarhus University Hospital is expected to follow.
Who cannot join
- Do not speak and understand Danish sufficiently to fill out questionnaires (due to dementia, some foreigners etc.)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Colonic Neoplasms, Rectal Neoplasms
- Being tested
- Nurse case management
- Keywords
- Case Management
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse case managementOther
Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nurse case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with care pathways(questionnaire)
Measured: 8, 30 and 52 weeks after inclusion and randomization
Quality of Life measures(questionnaire)
Measured: 8, 30 and 52 weeks after inclusion and randomization
Secondary outcomes (3)
Use of health care services during "the secondary care treatment period", i.e. GPs, emergency department, planned and emergency admission, total length of hospitalisation
Measured: 12 (and 6) months from diagnosis
GPs' evaluations of continuity of care (questionnaire).
Measured: 30 weeks after the patient's inclusion in the trial
Care process measures in terms of monitoring of data from the National Patient Registry
Measured: 12 (and 6) months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Research Unit for General Practice, Aarhus University, The Research Council for Health and Disease, Denmark, Danish Cancer Society, Novo Nordisk A/S, Kvalitets- og efteruddannelsesudvalget for Region Midtjylland
- Responsible party
- Sponsor
- Investigators
- Christian N Wulff, MD, Principal investigator, Research Unit of General Practice, Odense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845247
- Sponsor's protocol ID
- 477 980 567
- Other IDs
- Datatilsyn J.nr. 2008-41-2932
- Status last verified
- Aug 2012
- First submitted
- 13 Feb 2009
- Last updated
- 31 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23175735
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Case Management in Complex Cancer Pathways
- ClinicalTrials.gov ID
- NCT00845247
- Acronym / sponsor ID
- 477 980 567
- Conditions
- Colonic Neoplasms, Rectal Neoplasms
- Keywords
- Case Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Research Unit for General Practice, Aarhus University, The Research Council for Health and Disease, Denmark, Danish Cancer Society, Novo Nordisk A/S, Kvalitets- og efteruddannelsesudvalget for Region Midtjylland
- Study start
- Mar 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | –Control group patients will receive usual medical plus usual supportive treatment. |
| Case management | Active comparator | Other: Nurse case managementIntervention group patients are offered the support of a nurse case manager throughout their course of treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Colon or rectal cancer are highly suspected and a course of treatment at Department P, Aarhus University Hospital is expected to follow.
Key exclusion criteria (1 listed)
- Do not speak and understand Danish sufficiently to fill out questionnaires (due to dementia, some foreigners etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse case managementIntervention group patients are offered the support of a nurse case manager throughout their course of treatment. | Other | Case management |
Primary outcome
Patient satisfaction with care pathways(questionnaire)
Time frame: 8, 30 and 52 weeks after inclusion and randomization
Quality of Life measures(questionnaire)
Time frame: 8, 30 and 52 weeks after inclusion and randomization
3 secondary outcomes
Use of health care services during "the secondary care treatment period", i.e. GPs, emergency department, planned and emergency admission, total length of hospitalisation
Time frame: 12 (and 6) months from diagnosis
GPs' evaluations of continuity of care (questionnaire).
Time frame: 30 weeks after the patient's inclusion in the trial
Care process measures in terms of monitoring of data from the National Patient Registry
Time frame: 12 (and 6) months after diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
- Derived from this study: PubMed 23175735Wulff 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian N Wulff, MD principal investigator
Research Unit of General Practice, Odense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse case management in people with Colonic Neoplasms and Rectal Neoplasms, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction with care pathways(questionnaire) (time frame: 8, 30 and 52 weeks after inclusion and randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00845247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2012.