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

Primary Purpose

Colorectal Cancer, Screening, Patient Participation

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Re-invitation letter
Invitation to educational meeting
Sponsored by
Maria Sklodowska-Curie National Research Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring Colorectal Cancer, Screening, Colonoscopy, Attendance, Participation

Eligibility Criteria

55 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Maria Sklodowska-Curie Memorial Cancer Center, Institute of OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Re-invitation letter

Educational Meeting

Arm Description

Outcomes

Primary Outcome Measures

Attendance to screening colonoscopy
Percentage of invitees attending screening colonoscopy

Secondary Outcome Measures

Response rate to the re-invitation letter or invitation to the educational meeting
Percentage of invitees sending back reply form

Full Information

First Posted
August 16, 2010
Last Updated
February 14, 2011
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
National Center for Research and Development, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT01183156
Brief Title
Re-invitation to Screening Colonoscopy: a Randomized Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
National Center for Research and Development, Poland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Screening, Patient Participation
Keywords
Colorectal Cancer, Screening, Colonoscopy, Attendance, Participation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Re-invitation letter
Arm Type
Active Comparator
Arm Title
Educational Meeting
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Re-invitation letter
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Invitation to educational meeting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Attendance to screening colonoscopy
Description
Percentage of invitees attending screening colonoscopy
Time Frame
6 months from the date of re-invitation or invitation to educational meeting
Secondary Outcome Measure Information:
Title
Response rate to the re-invitation letter or invitation to the educational meeting
Description
Percentage of invitees sending back reply form
Time Frame
3 months from the date of reinvitation letter or date of invitation to the educational meeting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pisera Malgorzata
Phone
+48225463056
Email
mpisera@coi.waw.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Kaminski Michal
Phone
+48225463058
Email
mfkaminski@coi.waw.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Regula Jaroslaw, MD, PhD
Organizational Affiliation
Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Malgorzata Pisera, MSc
Organizational Affiliation
Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michal F Kaminski, MD
Organizational Affiliation
Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaminski Michal, MD
Phone
+48225463058
Email
mfkaminski@coi.waw.pl
First Name & Middle Initial & Last Name & Degree
Pisera Malgorzata, MSc
Phone
+48225463056
Email
mpisera@coi.waw.pl
First Name & Middle Initial & Last Name & Degree
Regula Jaroslaw, prof. MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26967693
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.
Results Reference
derived

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Re-invitation to Screening Colonoscopy: a Randomized Study

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