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
  Purpose

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.


Condition Intervention
Colorectal Cancer
Screening
Patient Participation
Behavioral: Re-invitation letter
Behavioral: Invitation to educational meeting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1000
Study Start Date: August 2010
Estimated Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Re-invitation letter 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.
Active Comparator: Educational Meeting 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.

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

Ages Eligible for Study:   55 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183156

Contacts
Contact: Pisera Malgorzata +48225463056 mpisera@coi.waw.pl
Contact: Kaminski Michal +48225463058 mfkaminski@coi.waw.pl

Locations
Poland
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology Recruiting
Warsaw, Poland, 02-781
Contact: Kaminski Michal, MD    +48225463058    mfkaminski@coi.waw.pl   
Contact: Pisera Malgorzata, MSc    +48225463056    mpisera@coi.waw.pl   
Principal Investigator: Regula Jaroslaw, prof. MD         
Sponsors and Collaborators
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
The National Centre for Research and Development, Poland
Investigators
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
  More Information

No publications provided

Responsible Party: Malgorzata Pisera, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier: NCT01183156     History of Changes
Other Study ID Numbers: NR13002404
Study First Received: August 16, 2010
Last Updated: February 14, 2011
Health Authority: Poland: Ethics Committee

Keywords provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:
Colorectal Cancer
Screening
Colonoscopy
Attendance
Participation

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 16, 2014