Colorectal CancerNCT01505972
Time Schedules for Sending Invitations to Colonoscopy Screening
A study testing Six and three time schedule and Four and two time schedule in people with Colorectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
The attendance rate to population based primary screening colonoscopy within NordICC trial (The Nordic-European Initiative on Colorectal Cancer, NCT00883792) in Poland is roughly 33%. Read more about this study
- Who is it for?
- Ages 55 to 64 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Six and three time schedule and Four and two time schedule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2011to Sep 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
- Individuals aged 55-64 years living in Warsaw area randomly drawn from Population Registry and randomized to the screening arm of the NordICC trial.
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).
- Individuals with previous colorectal surgery (resections, enterostomies)
- Individuals in need of long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
- On-going cytotoxic treatment or radiotherapy for malignant disease
Show all 10Show fewer
- Severe chronic (longer than trial duration) cardiac (NYHA III-IV)or lung disease
- Lifelong anticoagulant therapy with Warfarin
- A coronary event requiring hospitalization during the last 3 months
- A cerebrovascular event during the last 3 months
Trial locations and contacts
1 site in 1 country.
Poland1 site
Center of Oncology Institute and the Maria Sklodowska-Curie
Warsaw, W.K.Roentgena, 02-781
About this study
The attendance rate to population based primary screening colonoscopy within NordICC trial (The Nordic-European Initiative on Colorectal Cancer, NCT00883792) in Poland is roughly 33%. The aim of this study is to compare the effect of two different time schedules for sending invitations and reminding letters to a pre-specified colonoscopy appointment. 1,600 screening naive men and women 55 to 64 years of age are randomly assigned in a 1:1 ratio to receive invitation and reminder 6 and 3 weeks (SIX and THREE group) or 4 and 2 weeks (FOUR and TWO group) prior to pre-specified screening colonoscopy appointment date. Outcome measures are participation in screening colonoscopy within 6 months from the date of invitation, response and acceptance rate before sending a reminder. The study is powered to detect 7% difference in participation in screening colonoscopy.
- Conditions
- Colorectal Cancer
- Being tested
- Six and three time schedule, Four and two time schedule
- Keywords
- screening colonoscopy, attendance, response, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six and three time scheduleOther
Invitation letter sent 6 weeks and reminder 3 weeks before a pre-specified screening colonoscopy appointment date.
Four and two time scheduleOther
Invitation letter and reminder sent 4 and 2 weeks before pre-specified screening colonoscopy appointment date.
| Study group | Role | What they receive |
|---|---|---|
| Six and three time schedule | Experimental | Not described Receives: Other: Six and three time schedule |
| Four and two time schedule | Experimental | Not described Receives: Other: Four and two time schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate
Percentage of attenders to screening colonoscopy.
Measured: 6 months from the date of sending invitation letter
Secondary outcomes (4)
Acceptance rate in SIX &THREE group
Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder
Measured: 3 weeks from the date of sending invitation letter
Acceptance rate in FOUR&TWO group
Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder
Measured: 2 weeks from the date of sending invitation letter, respectively
Response rate in SIX&THREE group
Percentage of invitees who responded (by phone or letter) before sending a reminder
Measured: 3 weeks from the date of sending invitation letter
Response rate in FOUR&TWO group
Percentage of invitees who responded (by phone or letter) before sending a reminder
Measured: 2 weeks from the date of sending invitation letter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startMar 2011
- Primary completionSep 2011
- Study completionSep 2011
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,600 participants (actual)
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
- Responsible party
- Sponsor
- Investigators
- Regula Jaroslaw, MD, PhD, Study director, Center of Oncology UInstitute and the Maria Sklodowska-CurieKaminski F Michal, MD, Study chair, Center of Oncology Institute and the Maria Sklodowska-CuriePisera Malgorzata, Msc, Principal investigator, Center of Oncology Institute and the Maria Sklodowska-Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505972
- Sponsor's protocol ID
- NR13002404_1
- Status last verified
- Jan 2012
- First submitted
- 8 Dec 2011
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Schedules for Sending Invitations to Colonoscopy Screening
- ClinicalTrials.gov ID
- NCT01505972
- Acronym / sponsor ID
- NR13002404_1
- Conditions
- Colorectal Cancer
- Keywords
- screening colonoscopy, attendance, response, colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- National Center for Research and Development, Poland
- Study start
- Mar 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 9 Jan 2012 (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 attendance rate to population based primary screening colonoscopy within NordICC trial (The Nordic-European Initiative on Colorectal Cancer, NCT00883792) in Poland is roughly 33%. The aim of this study is to compare the effect of two different time schedules for sending invitations and reminding letters to a pre-specified colonoscopy appointment. 1,600 screening naive men and women 55 to 64 years of age are randomly assigned in a 1:1 ratio to receive invitation and reminder 6 and 3 weeks (SIX and THREE group) or 4 and 2 weeks (FOUR and TWO group) prior to pre-specified screening colonoscopy appointment date. Outcome measures are participation in screening colonoscopy within 6 months from the date of invitation, response and acceptance rate before sending a reminder. The study is powered to detect 7% difference in participation in 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 |
|---|---|---|
| Six and three time schedule | Experimental | Other: Six and three time schedule |
| Four and two time schedule | Experimental | Other: Four and two time schedule |
Who may qualify
- Ages
- 55 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals aged 55-64 years living in Warsaw area randomly drawn from Population Registry and randomized to the screening arm of the NordICC trial.
Key exclusion criteria (10 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).
- Individuals with previous colorectal surgery (resections, enterostomies)
- Individuals in need of long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
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 |
|---|---|---|
| Six and three time scheduleInvitation letter sent 6 weeks and reminder 3 weeks before a pre-specified screening colonoscopy appointment date. | Other | Six and three time schedule |
| Four and two time scheduleInvitation letter and reminder sent 4 and 2 weeks before pre-specified screening colonoscopy appointment date. | Other | Four and two time schedule |
Primary outcome
Participation rate
Time frame: 6 months from the date of sending invitation letter
Percentage of attenders to screening colonoscopy.
4 secondary outcomes
Acceptance rate in SIX &THREE group
Time frame: 3 weeks from the date of sending invitation letter
Acceptance rate in FOUR&TWO group
Time frame: 2 weeks from the date of sending invitation letter, respectively
Response rate in SIX&THREE group
Time frame: 3 weeks from the date of sending invitation letter
Response rate in FOUR&TWO group
Time frame: 2 weeks from the date of sending invitation letter
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 10 Jan 2012.
Related trials for Colorectal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Recruiting
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Cancer, Breast Cancer
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 UInstitute and the Maria Sklodowska-Curie
Kaminski F Michal, MD study chair
Center of Oncology Institute and the Maria Sklodowska-Curie
Pisera Malgorzata, Msc principal investigator
Center of Oncology Institute and the Maria Sklodowska-Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Six and three time schedule and Four and two time schedule in people with Colorectal Cancer, 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 10 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 10 Jan 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 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?
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?
Participation rate (time frame: 6 months from the date of sending invitation letter). 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 10 Jan 2012.