Time Schedules for Sending Invitations to Colonoscopy Screening

NCT ID: NCT01505972

Last Updated: 2012-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-09-30

Brief Summary

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Six and three time schedule

Group Type: EXPERIMENTAL

Six and three time schedule

Intervention Type: OTHER

Invitation letter sent 6 weeks and reminder 3 weeks before a pre-specified screening colonoscopy appointment date.

Four and two time schedule

Group Type: EXPERIMENTAL

Four and two time schedule

Intervention Type: OTHER

Invitation letter and reminder sent 4 and 2 weeks before pre-specified screening colonoscopy appointment date.

Interventions

Six and three time schedule

Invitation letter sent 6 weeks and reminder 3 weeks before a pre-specified screening colonoscopy appointment date.

Intervention Type: OTHER

Four and two time schedule

Invitation letter and reminder sent 4 and 2 weeks before pre-specified screening colonoscopy appointment date.

Intervention Type: OTHER

Eligibility Criteria

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).

• 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Research and Development, Poland

OTHER

Sponsor Role: collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Regula Jaroslaw, MD, PhD

Role: STUDY_DIRECTOR

Center of Oncology UInstitute and the Maria Sklodowska-Curie

Kaminski F Michal, MD

Role: STUDY_CHAIR

Center of Oncology Institute and the Maria Sklodowska-Curie

Pisera Malgorzata, Msc

Role: PRINCIPAL_INVESTIGATOR

Center of Oncology Institute and the Maria Sklodowska-Curie

Locations

Center of Oncology Institute and the Maria Sklodowska-Curie

Warsaw, W.K.Roentgena, Poland

Countries

Poland

Other Identifiers

NR13002404_1

Identifier Type: -

Identifier Source: org_study_id