NeoplasmsNCT00135980
Integrated Care for Cancer Patients; Developing, Implementing and Testing a Programme to Improve Integrated Care
A study testing professional audit and feedback and integrated care programmes in people with Neoplasms, run by Radboud University Medical Center at 6 sites in Netherlands.
Trial summary
The purpose of this study is to compose, implement and evaluate a programme to improve the quality of integrated care for patients with cancer. Literature will be searched for components of integrated care programmes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- professional audit and feedback and integrated care programmes
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 6 sitesNetherlands
- Study dates
- Aug 2004to Jul 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each new patient that visits the lung specialist in 6 hospitals in the east part of Holland, in the period from September 2004 till March 2005
Who cannot join
- Mortality
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Recruiting
Rijnstate Hospital
Arnhem
Hans Smit, MD, hsmit@alysis.nl
Marielle Ouwens, MSc
- Recruiting
MaasHospital Pantein
Boxmeer
René Bunnik, MD, mbunnik@maasziekenhuispantein.nl
Marielle Ouwens, MsC
- Recruiting
Slingeland Hosptital
Doetinchem
Gerrit Bosman, MD, G.Bosman@slingeland.nl
Marielle Ouwens, MSc
- Recruiting
Gelderse Vallei Hospital
Ede
Marietje Oudijk, MD, oudijkm@zgv.nl
Marielle Ouwens, MSc
- Recruiting
CWZ Hospital
Nijmegen
René Termeer, MD, A.Termeer@cwz.nl
Marielle Ouwens, MSc
- Recruiting
Radboud University Medical Centre
Nijmegen
Miep vanderDrift, MD, M.vanderdrift@ULC.umcn.nl
Marielle Ouwens, MSc
About this study
Official title: Integrated Care for Cancer Patients
The purpose of this study is to compose, implement and evaluate a programme to improve the quality of integrated care for patients with cancer.
Literature will be searched for components of integrated care programmes. On the basis of evidence based multi-disciplinary guidelines and literature on integrated care programmes, a set of indicators will be composed. This set will be measured in 6 hospitals on patients with non-small-cell-lung cancer. In two hospitals, an integrated care programme will be implemented and effects on processes and outcomes of care will be measured.
- Conditions
- Neoplasms
- Being tested
- professional audit and feedback, integrated care programmes
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
professional audit and feedbackBehavioural
integrated care programmesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
guideline adherence
Secondary outcomes (3)
hospitalization
satisfaction
quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startAug 2004
- Study completionJul 2007
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Rosella Hermens, MSc,PhD, Principal investigator, Centre for Quality of Care Research, Radboud University Nijmegen Medical CentreHub Wollersheim, MD,PhD, Study director, Centre for Quality of Care Research, Radboud University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135980
- Sponsor's protocol ID
- PACT-study M2100
- Other IDs
- M2100
- Status last verified
- Feb 2007
- First submitted
- 25 Aug 2005
- Last updated
- 1 Mar 2007
- Results posted
- No
Publications
Ouwens M, Wollersheim H, Hermens R, Hulscher M, Grol R. Integrated care programmes for chronically ill patients: a review of systematic reviews. Int J Qual Health Care. 2005 Apr;17(2):141-6. doi: 10.1093/intqhc/mzi016. Epub 2005 Jan 21.
PubMed 15665066
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Care for Cancer Patients
- ClinicalTrials.gov ID
- NCT00135980
- Acronym / sponsor ID
- PACT-study M2100
- Conditions
- Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Aug 2004
- Study completion
- Jul 2007
- First posted
- 26 Aug 2005 (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.
The purpose of this study is to compose, implement and evaluate a programme to improve the quality of integrated care for patients with cancer.
Literature will be searched for components of integrated care programmes. On the basis of evidence based multi-disciplinary guidelines and literature on integrated care programmes, a set of indicators will be composed. This set will be measured in 6 hospitals on patients with non-small-cell-lung cancer. In two hospitals, an integrated care programme will be implemented and effects on processes and outcomes of care will be measured.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Each new patient that visits the lung specialist in 6 hospitals in the east part of Holland, in the period from September 2004 till March 2005
Key exclusion criteria (1 listed)
- Mortality
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 |
|---|---|---|
| professional audit and feedback | Behavioural | – |
| integrated care programmes | Behavioural | – |
Primary outcome
guideline adherence
3 secondary outcomes
hospitalization
satisfaction
quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2007.
- Background: PubMed 15665066Ouwens M, Wollersheim H, Hermens R, Hulscher M, Grol R. Integrated care programmes for chronically ill patients: a review of systematic reviews. Int J Qual Health Care. 2005 Apr;17(2):141-6. doi: 10.1093/intqhc/mzi016. Epub 2005 Jan 21.
- Site of the Centre for Quality of Care ResearchLink provided by the sponsor.
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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.
Rosella Hermens, MSc,PhD principal investigator
Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre
Hub Wollersheim, MD,PhD study director
Centre for Quality of Care Research, Radboud University Medical Centre
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing professional audit and feedback and integrated care programmes in people with Neoplasms, run by Radboud University Medical Center at 6 sites in Netherlands.
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: status not confirmed, as of the sponsor's last update on 1 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marielle Ouwens, MSc (+31243613114, M.Ouwens@kwazo.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
guideline adherence. 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 NCT00135980, 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 1 Mar 2007.