Text Size

Time Schedules for Sending Invitations to Colonoscopy Screening

This study has been completed.
Sponsor:
Collaborator:
The National Centre for Research and Development, Poland
Information provided by (Responsible Party):
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01505972
First received: December 8, 2011
Last updated: January 6, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Colorectal Cancer
 Other: Six and three time schedule
Other: Four and two time schedule

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:

Primary Outcome Measures:
  • Participation rate [ Time Frame: 6 months from the date of sending invitation letter ] [ Designated as safety issue: No ]
    Percentage of attenders to screening colonoscopy.


Secondary Outcome Measures:
  • Acceptance rate in SIX &THREE group [ Time Frame: 3 weeks from the date of sending invitation letter ] [ Designated as safety issue: No ]
    Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder

  • Acceptance rate in FOUR&TWO group [ Time Frame: 2 weeks from the date of sending invitation letter, respectively ] [ Designated as safety issue: No ]
    Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder

  • Response rate in SIX&THREE group [ Time Frame: 3 weeks from the date of sending invitation letter ] [ Designated as safety issue: No ]
    Percentage of invitees who responded (by phone or letter) before sending a reminder

  • Response rate in FOUR&TWO group [ Time Frame: 2 weeks from the date of sending invitation letter ] [ Designated as safety issue: No ]
    Percentage of invitees who responded (by phone or letter) before sending a reminder


Enrollment: 1600
Study Start Date: March 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   55 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505972

Locations
Poland
Center of Oncology Institute and the Maria Sklodowska-Curie
Warsaw, W.K.Roentgena, Poland, 02-781
Sponsors and Collaborators
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
The National Centre 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
  More Information

No publications provided

Responsible Party: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier: NCT01505972     History of Changes
Other Study ID Numbers: NR13002404_1
Study First Received: December 8, 2011
Last Updated: January 6, 2012
Health Authority: Poland: Ethics Committee

Keywords provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:
screening colonoscopy
attendance
response
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 22, 2013