Re-invitation to Screening Colonoscopy: a Randomized Study
REINVITE
1 other identifier
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Aug 2010
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 16, 2010
CompletedFirst Posted
Study publicly available on registry
August 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFebruary 16, 2011
February 1, 2011
4 months
August 16, 2010
February 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Attendance to screening colonoscopy
Percentage of invitees attending screening colonoscopy
6 months from the date of re-invitation or invitation to educational meeting
Secondary Outcomes (1)
Response rate to the re-invitation letter or invitation to the educational meeting
3 months from the date of reinvitation letter or date of invitation to the educational meeting
Study Arms (2)
Re-invitation letter
ACTIVE COMPARATOREducational Meeting
ACTIVE COMPARATORInterventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Warsaw, 02-781, Poland
Related Publications (1)
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.
PMID: 26967693DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 16, 2010
First Posted
August 17, 2010
Study Start
August 1, 2010
Primary Completion
December 1, 2010
Study Completion
March 1, 2011
Last Updated
February 16, 2011
Record last verified: 2011-02