Time Schedules for Sending Invitations to Colonoscopy Screening

NCT01505972 | Completed

• 1 other identifier: NR13002404_1
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

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

Keywords

screening colonoscopy; attendance; response; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Participation rate

  Percentage of attenders to screening colonoscopy.

  6 months from the date of sending invitation letter

Secondary Outcomes (4)

• Acceptance rate in SIX &THREE group

  3 weeks from the date of sending invitation letter

• Acceptance rate in FOUR&TWO group

  2 weeks from the date of sending invitation letter, respectively

• Response rate in SIX&THREE group

  3 weeks from the date of sending invitation letter

• Response rate in FOUR&TWO group

  2 weeks from the date of sending invitation letter

Study Arms (2)

Six and three time schedule

EXPERIMENTAL

Other: Six and three time schedule

Four and two time schedule

EXPERIMENTAL

Other: Four and two time schedule

Interventions

Six and three time schedule OTHER

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

Six and three time schedule

Four and two time schedule OTHER

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

Four and two time schedule

Eligibility Criteria

• Age: 55 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• National Center for Research and Development, Poland: collaborator

Study Sites (1)

Center of Oncology Institute and the Maria Sklodowska-Curie

Warsaw, W.K.Roentgena, 02-781, Poland

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Regula Jaroslaw, MD, PhD

  Center of Oncology UInstitute and the Maria Sklodowska-Curie

  STUDY DIRECTOR

• Kaminski F Michal, MD

  Center of Oncology Institute and the Maria Sklodowska-Curie

  STUDY CHAIR

• Pisera Malgorzata, Msc

  Center of Oncology Institute and the Maria Sklodowska-Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: January 9, 2012
• Study Start: March 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 10, 2012

Record last verified: 2012-01

Locations

PL (1)