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

December 8, 2011
January 6, 2012
March 2011
September 2011   (final data collection date for primary outcome measure)
Participation rate [ Time Frame: 6 months from the date of sending invitation letter ] [ Designated as safety issue: No ]
Percentage of attenders to screening colonoscopy.
Same as current
Complete list of historical versions of study NCT01505972 on ClinicalTrials.gov Archive Site
  • 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
  • Response rate [ Time Frame: 3 weeks or 2 weeks from the date of sending invitation letter in SIX &THREE or FOUR&TWO group, respectively ] [ Designated as safety issue: No ]
    Percentage of responses before sending a reminder
  • Acceptance rate [ Time Frame: 3 weeks or 2 weeks from the date of sending invitation letter in SIX &THREE or FOUR&TWO group, respectively ] [ Designated as safety issue: No ]
    Percentage of invitees that agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder
Not Provided
Not Provided
 
Time Schedules for Sending Invitations to Colonoscopy Screening
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Colorectal Cancer
  • Other: Six and three time schedule
    Invitation letter sent 6 weeks and reminder 3 weeks before a pre-specified screening colonoscopy appointment date.
  • Other: Four and two time schedule
    Invitation letter and reminder sent 4 and 2 weeks before pre-specified screening colonoscopy appointment date.
  • Experimental: Six and three time schedule
    Intervention: Other: Six and three time schedule
  • Experimental: Four and two time schedule
    Intervention: Other: Four and two time schedule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1600
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
55 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01505972
NR13002404_1
No
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
The National Centre for Research and Development, Poland
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
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP