Colorectal CancerNCT02188927
Effect of an Advanced Notification Letter on Screening Colonoscopy Participation
A study testing Implementation of ANL and No included ANL in people with Colorectal Cancer and Adenoma, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
Participation in a primary screening colonoscopy programs remains low. Advanced notification letter has been shown to increase participation in colorectal cancer screening with fecal occult blood testing and to be cost effective compared to standard invitation. Read more about this study
- Who is it for?
- Ages 55 to 64 years
- Conditions the study is for
- Colorectal Cancer, Adenoma, Rectal Cancer
- What is being tested?
- Implementation of ANL and No included ANL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,800 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2014to Feb 2015
- 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 55 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all individuals aged 55-64 years living in the counties covered with the organized CRC screening program and assigned to invitation to screening colonoscopy in the year 2014 are eligible for the study.
Who cannot join
- message from neighbor/family/post office on death of screenee (not updated in Population Registry)
- resident abroad (not updated in Population Registry)
- return of unopened letter of invitation and/or reminder (address unknown)
- diagnosis of CRC before the date of draw (not updated in the National Cancer Registry)
Trial locations and contacts
1 site in 1 country.
Poland1 site
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Warsaw, Mazovian
Karolina Janikowska, MD, MSc, 22 546 30 58 ext. +48, kjanikowska@gmail.com
About this study
Official title: Participation in Screening Colonoscopy in Response to an Advanced Notification Letter Plus Standard Invitation Versus Standard Invitation Only - a Population-based Randomized Controlled Trial
Participation in a primary screening colonoscopy programs remains low. Advanced notification letter has been shown to increase participation in colorectal cancer screening with fecal occult blood testing and to be cost effective compared to standard invitation. It is unknown whether advanced notification letter increases participation rate in primary colonoscopy screening program.
We hypothesize that an Advance Notification Letter will have significant influence on participation in screening colonoscopy, comparing to standard invitation procedure and will thus result in higher efficiency of the program.
Read more
This randomized controlled study aims to compare the participation rate in screening colonoscopy in response to advanced notification plus standard invitation letter and standard invitation letter alone.
Material and methods: 6800 individuals aged 55-64 years will be drawn from the Population Registry and randomly assigned in a 1:1 ratio to the group invited for screening colonoscopy with advanced notification letter (send two weeks before standard invitation) plus standard invitation (send six weeks before planned screening colonoscopy) or to standard invitation only (send six weeks before planned screening colonoscopy). The sample size was calculated to detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.
- Conditions
- Colorectal Cancer, Adenoma, Rectal Cancer
- Being tested
- Implementation of ANL, No included ANL
- Keywords
- Advanced notification letter, Standard invitation, Participation rate, Colonoscopy, Screening, Colorectal Neoplasms, Digestive System Diseases
- Medical subject headings
- Colorectal Neoplasms, Adenoma, Rectal Neoplasms, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of ANLOther
Advance Notification Letter will be send two weeks before Standard Invitation for screening colonoscopy
No included ANLBehavioural
Sending Standard Invitation only six weeks before planned screening colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Implementation of ANL | Experimental | Intervention: Procedure : Implementation of routine Advanced Notification Letter included in Standard Invitation procedure
Advanced Notification Letter will be implemented in invitation procedure and send two weeks before Standard Invitation (Standard Invitation will be send six weeks before planned screening colonoscopy) Receives: Other: Implementation of ANL |
| No included ANL | Active comparator | Intervention: Behavioral : No included Advanced Notification Letter Sending Standard Invitation six weeks before planned screening colonoscopy Receives: Behavioral: No included ANL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate
A percentage of invitees who undergo the screening colonoscopy. The sample size was calculated to detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.
Measured: three months after receiving invitation
Secondary outcomes (1)
Response rate
Estimation of the invitees' response rate to Standard Invitation and Advanced Notification Letter followed by Standard Invitation, before receiving Reminding Letter.
Measured: three months after receiving invitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education, European Union
- Responsible party
- Sponsor
- Investigators
- Karolina Janikowska, MD,MSc, Principal investigator, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, PolandJaroslaw Regula, MD, PhD, Study chair, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, PolandBartlomiej Kocot, Study director, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188927
- Sponsor's protocol ID
- TEAM/2012-9/5
- Status last verified
- Jul 2014
- First submitted
- 11 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participation in Screening Colonoscopy in Response to an Advanced Notification Letter Plus Standard Invitation Versus Standard Invitation Only - a Population-based Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02188927
- Acronym / sponsor ID
- TEAM/2012-9/5
- Conditions
- Colorectal Cancer, Adenoma, Rectal Cancer
- Keywords
- Advanced notification letter, Standard invitation, Participation rate, Colonoscopy, Screening, Colorectal Neoplasms, Digestive System Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,800 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education, European Union
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 14 Jul 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.
Participation in a primary screening colonoscopy programs remains low. Advanced notification letter has been shown to increase participation in colorectal cancer screening with fecal occult blood testing and to be cost effective compared to standard invitation. It is unknown whether advanced notification letter increases participation rate in primary colonoscopy screening program.
We hypothesize that an Advance Notification Letter will have significant influence on participation in screening colonoscopy, comparing to standard invitation procedure and will thus result in higher efficiency of the program.
This randomized controlled study aims to compare the participation rate in screening colonoscopy in response to advanced notification plus standard invitation letter and standard invitation letter alone.
Material and methods: 6800 individuals aged 55-64 years will be drawn from the Population Registry and randomly assigned in a 1:1 ratio to the group invited for screening colonoscopy with advanced notification letter (send two weeks before standard invitation) plus standard invitation (send six weeks before planned screening colonoscopy) or to standard invitation only (send six weeks before planned screening colonoscopy). The sample size was calculated to detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implementation of ANL | Experimental | Other: Implementation of ANLIntervention: Procedure : Implementation of routine Advanced Notification Letter included in Standard Invitation procedure Advanced Notification Letter will be implemented in invitation procedure and send two weeks before Standard Invitation (Standard Invitation will be send six weeks before planned screening colonoscopy) |
| No included ANL | Active comparator | Behavioral: No included ANLIntervention: Behavioral : No included Advanced Notification Letter Sending Standard Invitation six weeks before planned screening colonoscopy |
Who may qualify
- Ages
- 55 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all individuals aged 55-64 years living in the counties covered with the organized CRC screening program and assigned to invitation to screening colonoscopy in the year 2014 are eligible for the study.
Key exclusion criteria (4 listed)
- message from neighbor/family/post office on death of screenee (not updated in Population Registry)
- resident abroad (not updated in Population Registry)
- return of unopened letter of invitation and/or reminder (address unknown)
- diagnosis of CRC before the date of draw (not updated in the National Cancer Registry)
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 |
|---|---|---|
| Implementation of ANLAdvance Notification Letter will be send two weeks before Standard Invitation for screening colonoscopy | Other | Implementation of ANL |
| No included ANLSending Standard Invitation only six weeks before planned screening colonoscopy | Behavioural | No included ANL |
Primary outcome
Participation rate
Time frame: three months after receiving invitation
A percentage of invitees who undergo the screening colonoscopy. The sample size was calculated to detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.
1 secondary outcome
Response rate
Time frame: three months after receiving invitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
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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.
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Warsaw, Poland
Karolina Janikowska, MD,MSc principal investigator
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Jaroslaw Regula, MD, PhD study chair
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Bartlomiej Kocot study director
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of ANL and No included ANL in people with Colorectal Cancer and Adenoma, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
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 4 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 14 Jul 2014. 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 Poland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate (time frame: three months after receiving invitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2014.