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Re-invitation to Screening Colonoscopy: a Randomized Study (REINVITE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The National Centre for Research and Development, Poland
Information provided by:
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01183156
First received: August 16, 2010
Last updated: February 14, 2011
Last verified: February 2011
History of Changes

August 16, 2010
February 14, 2011
August 2010
December 2010   (final data collection date for primary outcome measure)
Attendance to screening colonoscopy [ Time Frame: 6 months from the date of re-invitation or invitation to educational meeting ] [ Designated as safety issue: No ]
Percentage of invitees attending screening colonoscopy
Same as current
Complete list of historical versions of study NCT01183156 on ClinicalTrials.gov Archive Site
Response rate to the re-invitation letter or invitation to the educational meeting [ Time Frame: 3 months from the date of reinvitation letter or date of invitation to the educational meeting ] [ Designated as safety issue: No ]
Percentage of invitees sending back reply form
Same as current
Not Provided
Not Provided
 
Re-invitation to Screening Colonoscopy: a Randomized Study
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

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Colorectal Cancer
  • Screening
  • Patient Participation
  • 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.
  • 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.
  • Active Comparator: Re-invitation letter
    Intervention: Behavioral: Re-invitation letter
  • Active Comparator: Educational Meeting
    Intervention: Behavioral: Invitation to educational meeting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
March 2011
December 2010   (final data collection date for primary outcome measure)

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).
Both
55 Years to 64 Years
No
Contact: Pisera Malgorzata +48225463056 mpisera@coi.waw.pl
Contact: Kaminski Michal +48225463058 mfkaminski@coi.waw.pl
Poland
 
NCT01183156
NR13002404
No
Malgorzata Pisera, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
The National Centre for Research and Development, Poland
Study Director: Regula Jaroslaw, MD, PhD Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center
Principal Investigator: Malgorzata Pisera, MSc Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center
Study Chair: Michal F Kaminski, MD Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP