Time Schedules for Sending Invitations to Colonoscopy Screening

The attendance rate to population based primary screening colonoscopy within NordICC trial (The Nordic-European Initiative on Colorectal Cancer, NCT00883792) in Poland is roughly 33%. The aim of this study is to compare the effect of two different time schedules for sending invitations and reminding letters to a pre-specified colonoscopy appointment. 1,600 screening naive men and women 55 to 64 years of age are randomly assigned in a 1:1 ratio to receive invitation and reminder 6 and 3 weeks (SIX and THREE group) or 4 and 2 weeks (FOUR and TWO group) prior to pre-specified screening colonoscopy appointment date. Outcome measures are participation in screening colonoscopy within 6 months from the date of invitation, response and acceptance rate before sending a reminder. The study is powered to detect 7% difference in participation in screening colonoscopy.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Six and three time schedule; Other: Four and two time schedule

• Study Type: Interventional
• Enrollment (Actual): 1600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • W.K.Roentgena
    • Warsaw, W.K.Roentgena, Poland, 02-781
      • Center of Oncology Institute and the Maria Sklodowska-Curie

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:

Individuals aged 55-64 years living in Warsaw area randomly drawn from Population Registry and randomized to the screening arm of the NordICC trial.

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).

Exclusion criteria for colonoscopy:

• Individuals with previous colorectal surgery (resections, enterostomies)
• Individuals in need of long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
• On-going cytotoxic treatment or radiotherapy for malignant disease
• Severe chronic (longer than trial duration) cardiac (NYHA III-IV)or lung disease
• Lifelong anticoagulant therapy with Warfarin
• A coronary event requiring hospitalization during the last 3 months
• A cerebrovascular event during the last 3 months

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
Experimental: Six and three time schedule	Other: Six and three time schedule; Invitation letter sent 6 weeks and reminder 3 weeks before a pre-specified screening colonoscopy appointment date.
Experimental: Four and two time schedule	Other: Four and two time schedule; Invitation letter and reminder sent 4 and 2 weeks before pre-specified screening colonoscopy appointment date.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation rate	Percentage of attenders to screening colonoscopy.	6 months from the date of sending invitation letter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance rate in SIX &THREE group	Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder	3 weeks from the date of sending invitation letter
Acceptance rate in FOUR&TWO group	Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder	2 weeks from the date of sending invitation letter, respectively
Response rate in SIX&THREE group	Percentage of invitees who responded (by phone or letter) before sending a reminder	3 weeks from the date of sending invitation letter
Response rate in FOUR&TWO group	Percentage of invitees who responded (by phone or letter) before sending a reminder	2 weeks from the date of sending invitation letter

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 UInstitute and the Maria Sklodowska-Curie; Study Chair: Kaminski F Michal, MD, Center of Oncology Institute and the Maria Sklodowska-Curie; Principal Investigator: Pisera Malgorzata, Msc, Center of Oncology Institute and the Maria Sklodowska-Curie

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: December 8, 2011
• First Submitted That Met QC Criteria: January 4, 2012
• First Posted (Estimate): January 9, 2012

Study Record Updates

• Last Update Posted (Estimate): January 10, 2012
• Last Update Submitted That Met QC Criteria: January 6, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: colorectal cancer; response; screening colonoscopy; 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_1