Re-invitation to Screening Colonoscopy: a Randomized Study

Colorectal Cancer Clinical Trial

— REINVITE  

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01183156
• Other study ID #: NR13002404
• Status: Unknown status
• Phase: N/A
• First received: August 16, 2010
• Last updated: February 14, 2011
• Start date: August 2010
• Est. completion date: March 2011

Study information

• Verified date: February 2011
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: Pisera Malgorzata
• Phone: +48225463056
• Email: mpisera[@]coi.waw.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 1000
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 64 Years

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Patient Participation
• Screening

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Poland	Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology	The National Centre for Research and Development, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance to screening colonoscopy	Percentage of invitees attending screening colonoscopy	6 months from the date of re-invitation or invitation to educational meeting
Secondary	Response rate to the re-invitation letter or invitation to the educational meeting	Percentage of invitees sending back reply form	3 months from the date of reinvitation letter or date of invitation to the educational meeting