Colorectal CancerNCT02308384
A Trial of the Implementation of iFOBT in General Practice
A study testing Intervention in people with Colorectal Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
Background Colorectal cancer (CRC) is common, and a leading cause of cancer death. The evaluation of patients suspected to have CRC is difficult due to poorly predictive alarm symptoms and many patients present with uncharacteristic or vague symptoms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 825 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to Sep 2016
- 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
- GPs in the Central Denmark Region
- Patients >30 years eligible for iFOBT according to guideline
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Immunochemical Faecal Occult Blood Test (iFOBT) in General Practice. A Randomised Trial of the Implementation of iFOBT.
Background
Colorectal cancer (CRC) is common, and a leading cause of cancer death. The evaluation of patients suspected to have CRC is difficult due to poorly predictive alarm symptoms and many patients present with uncharacteristic or vague symptoms. The faecal marker of human globin, iFOBT, could play an important role in aiding the general practitioner in detecting CRC.
Read more
Hypothesis
It will be possible to implement iFOBT in general practice as a test performed on patients who do not fulfill the criteria for fast-track referral for colorectal cancer, but whose symptoms could indicate an undiagnosed colorectal cancer.
Aim
To implement iFOBT in general practice and evaluate the uptake and clinical use of the test. Furthermore, we want to investigate the performance of iFOBT when used on patients presenting with uncharacteristic symptoms of CRC, and the clinical implications.
Materials and methods
The study uses a cluster randomised stepped wedge design. Clusters are constituted by the 18 municipalities in the central Denmark Region, and these are randomised when to receive a continuous medical education (CME). The date of inclusion is defined as the first working day in the month the CME is planned to be conducted. The CME is part of an intervention aimed to facilitate the implementation of iFOBT in general practice. Besides a CME, the intervention consist of a start package (iFOBT kits, a guideline and online educational material) that is sent to GPs when they are included in the study, and a status mail that GPs receive approx. one month after inclusion. The inclusion period is during the first 7 month of the study period, the study lasts for one year.
Perspectives
This study will provide important knowledge on how to improve CRC diagnostics in general practice.
Read the detailed description
Background
Colorectal cancer (CRC) is the second most common type of cancer in Denmark and is a leading cause of cancer death. Since 2000, the incidence has been increasing by 1-1.5% each year. The estimated 5-year survival rate is currently 80% for stage I cancer, 50% for stages II and III, and <5 % for stage IV cancer. These figures emphasize the importance of detecting the disease in early stages and underline the current challenge of diagnosing CRC in general practice.
In 2008, a national fast-track system for cancer patients was established to ensure fast diagnosis and initiation of treatment. The fast-track system implies that patients presenting 'alarm' symptoms of e.g. CRC will be referred immediately for diagnostic workup; no more than 14 days must pass from referral to initiation of treatment. Several studies have shown that the positive predictive values (PPV) of the symptoms regarding CRC are fairly low (4-8%). In addition, approximately 50% of new CRC incidents will present with other vague and uncharacteristic symptoms than alarm symptoms.
In addition, a screening programme for CRC has been implemented. It is suggested that this will increase survival rate of CRC, however, it is estimated that approximately 75% of yearly CRC still have to be diagnosed through general practice.
A huge load is, consequently, still placed on general practice in the quest for earlier diagnosis of CRC, and better methods to aid the general practitioner in the diagnostic process are needed.
One tool could be the use of iFOBT in general practice for patients who present with symptoms that could origin from an underlying CRC, but without being alarm symptoms.
Aim
To implement iFOBT in general practice and evaluate the uptake and clinical use of the test. Furthermore, we want to investigate the performance of iFOBT when used on patients presenting with uncharacteristic symptoms of CRC, and the clinical implications.
Materials and methods
We will develop a guideline for the use of iFOBT in general practice. The guideline is aimed at men and women aged 30 years and above who present symptoms that could origin from a CRC, but are not classified as alarm symptoms. The guideline will contain a list of symptoms for which it is recommended to perform iFOBT and suggested actions for positive and negative test result. A value of <49µg/L will be considered 'negative' and >50µg/L as 'positive'.
The study uses a cluster randomised stepped wedge design, and is executed in the Central Denmark Region. Municipalities of the region are randomised when to receive a CME, and are included sequentially in the study during the first seven month of the study period. The CME are arranged on scheduled GP-meetings in each municipality and will consist of a 45 minutes lecture on CRC diagnosis and use of iFOBT. Besides a CME, the intervention consist of a start package (10 iFOBT kits, a guideline and online educational material) that is sent to GPs when they are included in the study, and a status mail that GPs receive approx. one month after inclusion. The study period is one year. Data analysis will focus on the uptake and clinical use of iFOBT in general practice, the performance of iFOBT when used on patients presenting with uncharacteristic symptoms of CRC and the clinical implications.
Perspectives
This study will investigate iFOBT and explore its role in general practice. To our knowledge, this study will be one of the first and most thorough investigations of this test in a primary care setting. The results will bring important knowledge of how to improve the diagnostics of colorectal cancer in the future and hopefully reduce time to diagnosis. Especially for patients who do not meet the traditional Danish criteria for fast-track referral, this study will be a corner stone in the identification of more efficient ways to locate patients at risk of developing CRC. At both national and international level, this project will contribute with important knowledge that may provide better planning of CRC diagnostics in the future.
- Conditions
- Colorectal Cancer
- Being tested
- Intervention
- Keywords
- iFOBT, FIT, general practice, early diagnosis
- Medical subject headings
- Colorectal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
CME, Start-package and status mail
| Study group | Role | What they receive |
|---|---|---|
| Before intervention | No intervention | GPs in this group have not yet received intervention. |
| After intervention | Experimental | GPs in this group have received the intervention. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of positive iFOBTs
Measured: 1 year
The number of CRCs diagnosed after a positive iFOBT
Measured: 1 year
The stage distribution of CRCs for patients with a positive iFOBT
UICC stages I-IV
Measured: 1 year
The positive predictive value for detecting colorectal cancer
The risk of having CRC when the iFOBT is positive
Measured: 1 year
The positive predictive value for detecting colorectal cancer in relation to cut-off value of iFOBT
The risk of having CRC at different iFOBT values.
Measured: 1 year
The positive predictive value for detecting colorectal cancer in relation to indications of using iFOBT
The risk of having CRC when iFOBT is positive and specific symptoms. When requesting FIT, the GP register the patients' symptoms.
Measured: 1 year
Secondary outcomes (6)
The rate of general practices starting to use the iFOBT, stratified for participation in the CME.
The relation between number of general practices started using iFOBT and time.
Measured: 1 year
The monthly rate of requested iFOBTs, stratified for participation in the CME.
The relation between number of requested iFOBTs and time.
Measured: 1 year
The monthly rate of positive iFOBTs, stratified for participation in the CME.
The relation between number of positive iFOBTs and time.
Measured: 1 year
Indications used for requesting iFOBT, stratified for participation in the CME.
Measured: 1 year
The rate of referrals in the cancer patient pathway for colorectal cancer
Measured: 1 year
The rate of performed colonoscopies
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionSep 2016
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 Colorectal CancerStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 825 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Vedsted, Professor, Study director, Research Unit of General Practice, Odense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308384
- Sponsor's protocol ID
- Randomiseret iFOBT studie
- Status last verified
- Nov 2015
- First submitted
- 26 Nov 2014
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Juul JS, Bro F, Hornung N, Andersen BS, Laurberg S, Olesen F, Vedsted P. Implementation of immunochemical faecal occult blood test in general practice: a study protocol using a cluster-randomised stepped-wedge design. BMC Cancer. 2016 Jul 11;16:445. doi: 10.1186/s12885-016-2477-9.
PubMed 27400657
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Immunochemical Faecal Occult Blood Test (iFOBT) in General Practice. A Randomised Trial of the Implementation of iFOBT.
- ClinicalTrials.gov ID
- NCT02308384
- Acronym / sponsor ID
- Randomiseret iFOBT studie
- Conditions
- Colorectal Cancer
- Keywords
- iFOBT, FIT, general practice, early diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 825 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 Dec 2014 (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.
Background
Colorectal cancer (CRC) is common, and a leading cause of cancer death. The evaluation of patients suspected to have CRC is difficult due to poorly predictive alarm symptoms and many patients present with uncharacteristic or vague symptoms. The faecal marker of human globin, iFOBT, could play an important role in aiding the general practitioner in detecting CRC.
Hypothesis
It will be possible to implement iFOBT in general practice as a test performed on patients who do not fulfill the criteria for fast-track referral for colorectal cancer, but whose symptoms could indicate an undiagnosed colorectal cancer.
Aim
To implement iFOBT in general practice and evaluate the uptake and clinical use of the test. Furthermore, we want to investigate the performance of iFOBT when used on patients presenting with uncharacteristic symptoms of CRC, and the clinical implications.
Materials and methods
The study uses a cluster randomised stepped wedge design. Clusters are constituted by the 18 municipalities in the central Denmark Region, and these are randomised when to receive a continuous medical education (CME). The date of inclusion is defined as the first working day in the month the CME is planned to be conducted. The CME is part of an intervention aimed to facilitate the implementation of iFOBT in general practice. Besides a CME, the intervention consist of a start package (iFOBT kits, a guideline and online educational material) that is sent to GPs when they are included in the study, and a status mail that GPs receive approx. one month after inclusion. The inclusion period is during the first 7 month of the study period, the study lasts for one year.
Perspectives
This study will provide important knowledge on how to improve CRC diagnostics in general practice.
Detailed description
Background
Colorectal cancer (CRC) is the second most common type of cancer in Denmark and is a leading cause of cancer death. Since 2000, the incidence has been increasing by 1-1.5% each year. The estimated 5-year survival rate is currently 80% for stage I cancer, 50% for stages II and III, and <5 % for stage IV cancer. These figures emphasize the importance of detecting the disease in early stages and underline the current challenge of diagnosing CRC in general practice.
In 2008, a national fast-track system for cancer patients was established to ensure fast diagnosis and initiation of treatment. The fast-track system implies that patients presenting 'alarm' symptoms of e.g. CRC will be referred immediately for diagnostic workup; no more than 14 days must pass from referral to initiation of treatment. Several studies have shown that the positive predictive values (PPV) of the symptoms regarding CRC are fairly low (4-8%). In addition, approximately 50% of new CRC incidents will present with other vague and uncharacteristic symptoms than alarm symptoms.
In addition, a screening programme for CRC has been implemented. It is suggested that this will increase survival rate of CRC, however, it is estimated that approximately 75% of yearly CRC still have to be diagnosed through general practice.
A huge load is, consequently, still placed on general practice in the quest for earlier diagnosis of CRC, and better methods to aid the general practitioner in the diagnostic process are needed.
One tool could be the use of iFOBT in general practice for patients who present with symptoms that could origin from an underlying CRC, but without being alarm symptoms.
Aim
To implement iFOBT in general practice and evaluate the uptake and clinical use of the test. Furthermore, we want to investigate the performance of iFOBT when used on patients presenting with uncharacteristic symptoms of CRC, and the clinical implications.
Materials and methods
We will develop a guideline for the use of iFOBT in general practice. The guideline is aimed at men and women aged 30 years and above who present symptoms that could origin from a CRC, but are not classified as alarm symptoms. The guideline will contain a list of symptoms for which it is recommended to perform iFOBT and suggested actions for positive and negative test result. A value of <49µg/L will be considered 'negative' and >50µg/L as 'positive'.
The study uses a cluster randomised stepped wedge design, and is executed in the Central Denmark Region. Municipalities of the region are randomised when to receive a CME, and are included sequentially in the study during the first seven month of the study period. The CME are arranged on scheduled GP-meetings in each municipality and will consist of a 45 minutes lecture on CRC diagnosis and use of iFOBT. Besides a CME, the intervention consist of a start package (10 iFOBT kits, a guideline and online educational material) that is sent to GPs when they are included in the study, and a status mail that GPs receive approx. one month after inclusion. The study period is one year. Data analysis will focus on the uptake and clinical use of iFOBT in general practice, the performance of iFOBT when used on patients presenting with uncharacteristic symptoms of CRC and the clinical implications.
Perspectives
This study will investigate iFOBT and explore its role in general practice. To our knowledge, this study will be one of the first and most thorough investigations of this test in a primary care setting. The results will bring important knowledge of how to improve the diagnostics of colorectal cancer in the future and hopefully reduce time to diagnosis. Especially for patients who do not meet the traditional Danish criteria for fast-track referral, this study will be a corner stone in the identification of more efficient ways to locate patients at risk of developing CRC. At both national and international level, this project will contribute with important knowledge that may provide better planning of CRC diagnostics in the future.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before intervention | No intervention | –GPs in this group have not yet received intervention. |
| After intervention | Experimental | Behavioral: InterventionGPs in this group have received the intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- GPs in the Central Denmark Region
- Patients >30 years eligible for iFOBT according to guideline
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| InterventionCME, Start-package and status mail | Behavioural | After intervention |
Primary outcome
The rate of positive iFOBTs
Time frame: 1 year
The number of CRCs diagnosed after a positive iFOBT
Time frame: 1 year
The stage distribution of CRCs for patients with a positive iFOBT
Time frame: 1 year
UICC stages I-IV
The positive predictive value for detecting colorectal cancer
Time frame: 1 year
The risk of having CRC when the iFOBT is positive
The positive predictive value for detecting colorectal cancer in relation to cut-off value of iFOBT
Time frame: 1 year
The risk of having CRC at different iFOBT values.
The positive predictive value for detecting colorectal cancer in relation to indications of using iFOBT
Time frame: 1 year
The risk of having CRC when iFOBT is positive and specific symptoms. When requesting FIT, the GP register the patients' symptoms.
6 secondary outcomes
The rate of general practices starting to use the iFOBT, stratified for participation in the CME.
Time frame: 1 year
The monthly rate of requested iFOBTs, stratified for participation in the CME.
Time frame: 1 year
The monthly rate of positive iFOBTs, stratified for participation in the CME.
Time frame: 1 year
Indications used for requesting iFOBT, stratified for participation in the CME.
Time frame: 1 year
The rate of referrals in the cancer patient pathway for colorectal cancer
Time frame: 1 year
The rate of performed colonoscopies
Time frame: 1 year
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 27 Apr 2017.
- Derived from this study: PubMed 27400657Juul JS, Bro F, Hornung N, Andersen BS, Laurberg S, Olesen F, Vedsted P. Implementation of immunochemical faecal occult blood test in general practice: a study protocol using a cluster-randomised stepped-wedge design. BMC Cancer. 2016 Jul 11;16:445. doi: 10.1186/s12885-016-2477-9.
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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.
Peter Vedsted, Professor study director
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 Intervention in people with Colorectal Cancer, 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 2 inclusion and 0 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 27 Apr 2017. 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. 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?
The rate of positive iFOBTs (time frame: 1 year). The study lists 6 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 NCT02308384, 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 27 Apr 2017.