Colorectal CancerEarly Phase 1NCT01182922
Information About a Doctor or a Possibility of Choosing Doctor's Gender and Attendance to Screening Colonoscopy
A Early Phase 1 study testing Invitation letter 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 purpose of the study is to investigate whether the information about a doctor or possibility to choose doctor's gender included in invitation letter is associated with attendance rate 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
- What is being tested?
- Invitation letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,100 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2010to Aug 2011
- Phase
- Early Phase 1
- 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 55-64 years of age randomized to the screening arm of the NordICC trial in Poland
Who cannot join
- previous open colorectal surgery
- need for long term attention and nursing services (somatic or psychosocial reasons, mental retardation)
- ongoing cytotoxic treatment or radiotherapy for malignant disease
- severe chronic cardiac or pulmonary disease (NYHA III and IV)
- lifelong anticoagulant treatment
- coronary or cerebrovascular incident requiring hospitalization during the last three months
Show all 10Show fewer
- residence abroad
- return of unopened letter of invitation and/or reminder, or message of death of the subject (not updated in Population Registry)
- failure to provide written informed consent
- screening colonoscopy within 10 years
Trial locations and contacts
1 site in 1 country.
Poland1 site
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology,
Warsaw, 02-781
About this study
Official title: Is the Information About a Doctor or Possibility of Choosing Doctor's Gender Associated With Attendance to Screening Colonoscopy: Randomized Study With Three Types of Invitations.
The purpose of the study is to investigate whether the information about a doctor or possibility to choose doctor's gender included in invitation letter is associated with attendance rate to screening colonoscopy.
Read the detailed description
Study is performed as a part of NordICC (Clinical trials NCT 00883792) trial, which is intended to investigate the effect of screening colonoscopy on colorectal cancer incidence and mortality. NordICC trial is a multicenter, randomized study conducted in Norway, Sweden, Netherlands and Poland.
This study is designed to assess two factors potentially influencing patients attendance. These two factors are: identification of particular doctor performing examination and the possibility of choosing doctor's gender.
- Conditions
- Colorectal Cancer, Screening
- Being tested
- Invitation letter
- Keywords
- Attendance, Colorectal cancer, Screening, Invitation letter
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation letterBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Doctor's Information Invitation | Active comparator | Standard invitation with additional leaflet containing information concerning particular doctor performing the examination, that is: his personal data (name, surname, academic title, workplace, picture) and data concerning experience and achievements of the center where he is employed. Receives: Behavioral: Invitation letter |
| Gender Preference Invitation | Active comparator | Standard invitation with additional information about possibility of choosing doctor's gender, mentioned below proposed date of examination Receives: Behavioral: Invitation letter |
| Standard Invitation | Active comparator | Standard invitation without additional information about a doctor or possibility of choosing doctor's gender. Receives: Behavioral: Invitation letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of invitees attending screening colonoscopy in each invitation letter group
Measured: 3 months from the primary assigned screening appointment date
Secondary outcomes (1)
Percentage of forms with consent for examination, sent back after invitation letter but before reminding letter. Differences in attendance between men and women depending on type of the invitation.
Measured: 3 weeks after the date of invitation letter
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 completionMar 2011
- Study completionAug 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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaroslaw Regula, MD, PhD, Study director, Center of Oncology InstituteKrzysztof Skoczylas, MD, Principal investigator, Center of Oncology InstituteMichal F Kaminski, MD, Study chair, Center of Oncology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182922
- Sponsor's protocol ID
- CO-I
- Status last verified
- Nov 2011
- First submitted
- 15 Aug 2010
- Last updated
- 18 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Information About a Doctor or Possibility of Choosing Doctor's Gender Associated With Attendance to Screening Colonoscopy: Randomized Study With Three Types of Invitations.
- ClinicalTrials.gov ID
- NCT01182922
- Acronym / sponsor ID
- CO-I
- Conditions
- Colorectal Cancer, Screening
- Keywords
- Attendance, Colorectal cancer, Screening, Invitation letter
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,100 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Aug 2011 (actual)
- 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 purpose of the study is to investigate whether the information about a doctor or possibility to choose doctor's gender included in invitation letter is associated with attendance rate to screening colonoscopy.
Detailed description
Study is performed as a part of NordICC (Clinical trials NCT 00883792) trial, which is intended to investigate the effect of screening colonoscopy on colorectal cancer incidence and mortality. NordICC trial is a multicenter, randomized study conducted in Norway, Sweden, Netherlands and Poland.
This study is designed to assess two factors potentially influencing patients attendance. These two factors are: identification of particular doctor performing examination and the possibility of choosing doctor's gender.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Doctor's Information Invitation | Active comparator | Behavioral: Invitation letterStandard invitation with additional leaflet containing information concerning particular doctor performing the examination, that is: his personal data (name, surname, academic title, workplace, picture) and data concerning experience and achievements of the center where he is employed. |
| Gender Preference Invitation | Active comparator | Behavioral: Invitation letterStandard invitation with additional information about possibility of choosing doctor's gender, mentioned below proposed date of examination |
| Standard Invitation | Active comparator | Behavioral: Invitation letterStandard invitation without additional information about a doctor or possibility of choosing doctor's gender. |
Who may qualify
- Ages
- 55 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals 55-64 years of age randomized to the screening arm of the NordICC trial in Poland
Key exclusion criteria (10 listed)
- previous open colorectal surgery
- need for long term attention and nursing services (somatic or psychosocial reasons, mental retardation)
- ongoing cytotoxic treatment or radiotherapy for malignant disease
- severe chronic cardiac or pulmonary disease (NYHA III and IV)
- lifelong anticoagulant treatment
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 |
|---|---|---|
| Invitation letterInvitation 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 | Doctor's Information Invitation, Gender Preference Invitation, Standard Invitation |
Primary outcome
Percentage of invitees attending screening colonoscopy in each invitation letter group
Time frame: 3 months from the primary assigned screening appointment date
1 secondary outcome
Percentage of forms with consent for examination, sent back after invitation letter but before reminding letter. Differences in attendance between men and women depending on type of the invitation.
Time frame: 3 weeks after the date of 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 18 Nov 2011.
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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.
Jaroslaw Regula, MD, PhD study director
Center of Oncology Institute
Krzysztof Skoczylas, MD principal investigator
Center of Oncology Institute
Michal F Kaminski, MD study chair
Center of Oncology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Invitation letter 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 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 18 Nov 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of invitees attending screening colonoscopy in each invitation letter group (time frame: 3 months from the primary assigned screening appointment date). 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 18 Nov 2011.