Clinical trial NCT01183156: Re-invitation to Screening Colonoscopy: a Randomized 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Screening
Patient Participation
Keywords: Colorectal Cancer
Screening
Colonoscopy
Attendance
Participation
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: National Center for Research and Development, Poland
First posted: 2010-08-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 55
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Attendance to screening colonoscopy
timeFrame: 6 months from the date of re-invitation or invitation to educational meeting
Secondary outcomes:
measure: Response rate to the re-invitation letter or invitation to the educational meeting
timeFrame: 3 months from the date of reinvitation letter or date of invitation to the educational meeting
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Study officials:
affiliation: Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center
name: Regula Jaroslaw, MD, PhD
role: STUDY_DIRECTOR
affiliation: Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center
name: Malgorzata Pisera, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center
name: Michal F Kaminski, MD
role: STUDY_CHAIR
References:
citation: 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.