Time Schedules for Sending Invitations to Colonoscopy Screening

January 6, 2012 updated by: Maria Sklodowska-Curie National Research Institute of Oncology
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 months from the date of sending invitation letter
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
Time Frame: 3 weeks from the date of sending invitation letter
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
Time Frame: 2 weeks from the date of sending invitation letter, respectively
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
Time Frame: 3 weeks from the date of sending invitation letter
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
Time Frame: 2 weeks from the date of sending invitation letter
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NR13002404_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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