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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Patient Participation; Screening
• Intervention / Treatment: Behavioral: Re-invitation letter; Behavioral: Invitation to educational meeting

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-781
    • Recruiting
    • Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
    • Contact: Kaminski Michal, MD; Phone Number: +48225463058; Email: mfkaminski@coi.waw.pl
    • Contact: Pisera Malgorzata, MSc; Phone Number: +48225463056; Email: mpisera@coi.waw.pl
    • Principal Investigator: Regula Jaroslaw, prof. MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance to screening colonoscopy	Percentage of invitees attending screening colonoscopy	6 months from the date of re-invitation or invitation to educational meeting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Collaborators: National Center 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Anticipated): March 1, 2011

Study Registration Dates

• First Submitted: August 16, 2010
• First Submitted That Met QC Criteria: August 16, 2010
• First Posted (Estimate): August 17, 2010

Study Record Updates

• Last Update Posted (Estimate): February 16, 2011
• Last Update Submitted That Met QC Criteria: February 14, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Screening; Colorectal Cancer; Colonoscopy; Participation; Attendance
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NR13002404