Colorectal CancerREINVITENCT01183156
Re-invitation to Screening Colonoscopy: a Randomized Study
A study testing Re-invitation letter and Invitation to educational meeting in people with Colorectal Cancer and Screening, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
The aim of this study is to compare the effect of reminding letter and educational intervention on attendance to screening colonoscopy in nonresponders to initial invitation to screening colonoscopy. Read more about this study
- Who is it for?
- Ages 55 to 64 years
- Conditions the study is for
- Colorectal Cancer, Screening, Patient Participation
- What is being tested?
- Re-invitation letter and Invitation to educational meeting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2010to Mar 2011
- 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
- Men and women 55-64 years of age invited for screening colonoscopy within the NordICC trial (NCT00883792) in Poland, who have not responded to the first invitation.
Who cannot join
- Resident abroad
- Return of unopened letter of invitation and/or reminder (address unknown)
- Message from neighbour/family/post office on death of screenee (not updated in Population Registry).
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Warsaw, 02-781
Kaminski Michal, MD, +48225463058, mfkaminski@coi.waw.pl
Pisera Malgorzata, MSc, +48225463056, mpisera@coi.waw.pl
About this study
Official title: Re-invitation to Screening Colonoscopy: a Randomized Controlled Trial of Reminding Letter and Educational Intervention on Attendance in Nonresponders to Initial Invitation to Screening Colonoscopy
The aim of this study is to compare the effect of reminding letter and educational intervention on attendance to screening colonoscopy in nonresponders to initial invitation to screening colonoscopy.
Read the detailed description
NordICC (The NordICC Initiative on Colorectal Cancer, NCT00883792) is a multicenter randomised trial to investigate the effect of screening colonoscopy on CRC incidence and mortality. In Poland, in Warsaw area, at least 10,000 subjects 55-64 years of age are to be invited to screening colonoscopy. A personal letter of invitation containing date and hour of appointment is mailed to every individual randomised to the screening group. Up to 60% of invitees do not respond to the initial invitation and reminding letter. The aim of this study is to compare the effect of reminding letter and educational intervention on attendance to screening colonoscopy in nonresponders to initial invitation to screening colonoscopy.
- Conditions
- Colorectal Cancer, Screening, Patient Participation
- Being tested
- Re-invitation letter, Invitation to educational meeting
- Keywords
- Colorectal Cancer, Screening, Colonoscopy, Attendance, Participation
- Medical subject headings
- Colorectal Neoplasms, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-invitation letterBehavioural
Re-invitation letter sent 6 weeks prior to prespecified screening colonoscopy appointment date and followed by reminder letter within 3 weeks if no response is received.
Invitation to educational meetingBehavioural
Invitation will be sent 6 weeks prior to educational meeting date and followed by a reminding letter 3 weeks later. Educational meetings will be held in a local culture developement centers and conducted by a medical team responsible for the Polish Colorectal Cancer Screening Program. The aim of the meeting is to overcome barriers to screening colonoscopy. The program of the meeting is tailored to individual needs, doubts, and concerns of the participating group as assessed using brief survey at the beginning of the meeting. The major points to be discussed are: risk and benefit of screening, colorectal cancer risk, pain and sedation, preparation to colonoscopy, consecutive stages of the procedure, comfort and embarrassment.
| Study group | Role | What they receive |
|---|---|---|
| Re-invitation letter | Active comparator | Not described Receives: Behavioral: Re-invitation letter |
| Educational Meeting | Active comparator | Not described Receives: Behavioral: Invitation to educational meeting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance to screening colonoscopy
Percentage of invitees attending screening colonoscopy
Measured: 6 months from the date of re-invitation or invitation to educational meeting
Secondary outcomes (1)
Response rate to the re-invitation letter or invitation to the educational meeting
Percentage of invitees sending back reply form
Measured: 3 months from the date of reinvitation letter or date of invitation to the educational meeting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionMar 2011 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research and Development, Poland
- Investigators
- Regula Jaroslaw, MD, PhD, Study director, Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer CenterMalgorzata Pisera, MSc, Principal investigator, Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer CenterMichal F Kaminski, MD, Study chair, Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183156
- Sponsor's protocol ID
- NR13002404
- Acronym
- REINVITE
- Status last verified
- Feb 2011
- First submitted
- 16 Aug 2010
- Last updated
- 16 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Pisera M, Kaminski MF, Kraszewska E, Rupinski M, Regula J. Reinvitation to screening colonoscopy: a randomized-controlled trial of reminding letter and invitation to educational meeting on attendance in nonresponders to initial invitation to screening colonoscopy (REINVITE). Eur J Gastroenterol Hepatol. 2016 May;28(5):538-42. doi: 10.1097/MEG.0000000000000578.
PubMed 26967693
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-invitation to Screening Colonoscopy: a Randomized Controlled Trial of Reminding Letter and Educational Intervention on Attendance in Nonresponders to Initial Invitation to Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT01183156
- Acronym / sponsor ID
- REINVITE / NR13002404
- Conditions
- Colorectal Cancer, Screening, Patient Participation
- Keywords
- Colorectal Cancer, Screening, Colonoscopy, Attendance, Participation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- National Center for Research and Development, Poland
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (estimated)
- First posted
- 17 Aug 2010 (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 aim of this study is to compare the effect of reminding letter and educational intervention on attendance to screening colonoscopy in nonresponders to initial invitation to screening colonoscopy.
Detailed description
NordICC (The NordICC Initiative on Colorectal Cancer, NCT00883792) is a multicenter randomised trial to investigate the effect of screening colonoscopy on CRC incidence and mortality. In Poland, in Warsaw area, at least 10,000 subjects 55-64 years of age are to be invited to screening colonoscopy. A personal letter of invitation containing date and hour of appointment is mailed to every individual randomised to the screening group. Up to 60% of invitees do not respond to the initial invitation and reminding letter. The aim of this study is to compare the effect of reminding letter and educational intervention on attendance to screening colonoscopy in nonresponders to initial invitation to screening colonoscopy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Re-invitation letter | Active comparator | Behavioral: Re-invitation letter |
| Educational Meeting | Active comparator | Behavioral: Invitation to educational meeting |
Who may qualify
- Ages
- 55 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men and women 55-64 years of age invited for screening colonoscopy within the NordICC trial (NCT00883792) in Poland, who have not responded to the first invitation.
Key exclusion criteria (3 listed)
- Resident abroad
- Return of unopened letter of invitation and/or reminder (address unknown)
- Message from neighbour/family/post office on death of screenee (not updated in Population 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 |
|---|---|---|
| Re-invitation letterRe-invitation letter sent 6 weeks prior to prespecified screening colonoscopy appointment date and followed by reminder letter within 3 weeks if no response is received. | Behavioural | Re-invitation letter |
| Invitation to educational meetingInvitation will be sent 6 weeks prior to educational meeting date and followed by a reminding letter 3 weeks later. Educational meetings will be held in a local culture developement centers and conducted by a medical team responsible for the Polish Colorectal Cancer Screening Program. The aim of the meeting is to overcome barriers to screening colonoscopy. The program of the meeting is tailored to individual needs, doubts, and concerns of the participating group as assessed using brief survey at the beginning of the meeting. The major points to be discussed are: risk and benefit of screening, colorectal cancer risk, pain and sedation, preparation to colonoscopy, consecutive stages of the procedure, comfort and embarrassment. | Behavioural | Educational Meeting |
Primary outcome
Attendance to screening colonoscopy
Time frame: 6 months from the date of re-invitation or invitation to educational meeting
Percentage of invitees attending screening colonoscopy
1 secondary outcome
Response rate to the re-invitation letter or invitation to the educational meeting
Time frame: 3 months from the date of reinvitation letter or date of invitation to the educational meeting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2011.
- Derived from this study: PubMed 26967693Pisera M, Kaminski MF, Kraszewska E, Rupinski M, Regula J. Reinvitation to screening colonoscopy: a randomized-controlled trial of reminding letter and invitation to educational meeting on attendance in nonresponders to initial invitation to screening colonoscopy (REINVITE). Eur J Gastroenterol Hepatol. 2016 May;28(5):538-42. doi: 10.1097/MEG.0000000000000578.
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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.
Regula Jaroslaw, MD, PhD study director
Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center
Malgorzata Pisera, MSc principal investigator
Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center
Michal F Kaminski, MD study chair
Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-invitation letter and Invitation to educational meeting in people with Colorectal Cancer and Screening, 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 3 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 16 Feb 2011. 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?
Contact Pisera Malgorzata (+48225463056, mpisera@coi.waw.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance to screening colonoscopy (time frame: 6 months from the date of re-invitation or invitation to educational meeting). 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 NCT01183156, 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 16 Feb 2011.