Re-invitation to Screening Colonoscopy: a Randomized Study

NCT ID: NCT01183156

Last Updated: 2011-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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

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Colorectal Cancer Screening Patient Participation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Re-invitation letter

Group Type ACTIVE_COMPARATOR

Re-invitation letter

Intervention Type BEHAVIORAL

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.

Educational Meeting

Group Type ACTIVE_COMPARATOR

Invitation to educational meeting

Intervention Type BEHAVIORAL

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.

Interventions

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Re-invitation letter

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.

Intervention Type BEHAVIORAL

Invitation to educational meeting

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
Minimum Eligible Age

55 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Research and Development, Poland

OTHER

Sponsor Role collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Principal Investigators

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Regula Jaroslaw, MD, PhD

Role: STUDY_DIRECTOR

Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center

Malgorzata Pisera, MSc

Role: PRINCIPAL_INVESTIGATOR

Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center

Michal F Kaminski, MD

Role: STUDY_CHAIR

Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center

Locations

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Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Pisera Malgorzata

Role: CONTACT

+48225463056

Kaminski Michal

Role: CONTACT

+48225463058

Facility Contacts

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Kaminski Michal, MD

Role: primary

+48225463058

Pisera Malgorzata, MSc

Role: backup

+48225463056

References

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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.

Reference Type DERIVED
PMID: 26967693 (View on PubMed)

Other Identifiers

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NR13002404

Identifier Type: -

Identifier Source: org_study_id

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