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Time Schedules for Sending Invitations to Colonoscopy Screening

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ClinicalTrials.gov Identifier: NCT01505972
Recruitment Status : Completed
First Posted : January 9, 2012
Last Update Posted : January 10, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Colorectal Cancer Other: Six and three time schedule Other: Four and two time schedule

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Study Start Date : March 2011
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Participation rate [ Time Frame: 6 months from the date of sending invitation letter ]
    Percentage of attenders to screening colonoscopy.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier: NCT01505972     History of Changes
Other Study ID Numbers: NR13002404_1
First Posted: January 9, 2012    Key Record Dates
Last Update Posted: January 10, 2012
Last Verified: January 2012

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