Is the Information About a Doctor or Possibility of Choosing Doctor's Gender Associated With Attendance to Screening Colonoscopy: Randomized Study With Three Types of Invitations.
55 Years
64 Years
Both
Colorectal Cancer, Screening
Trial Information
Is the Information About a Doctor or Possibility of Choosing Doctor's Gender Associated With Attendance to Screening Colonoscopy: Randomized Study With Three Types of Invitations.
Study is performed as a part of NordICC (Clinical trials NCT 00883792) trial, which is
intended to investigate the effect of screening colonoscopy on colorectal cancer incidence
and mortality. NordICC trial is a multicenter, randomized study conducted in Norway, Sweden,
Netherlands and Poland.
This study is designed to assess two factors potentially influencing patients attendance.
These two factors are: identification of particular doctor performing examination and the
possibility of choosing doctor's gender.
Inclusion Criteria:
- Individuals 55-64 years of age randomized to the screening arm of the NordICC trial
in Poland
Exclusion Criteria:
- previous open colorectal surgery
- need for long term attention and nursing services (somatic or psychosocial reasons,
mental retardation)
- ongoing cytotoxic treatment or radiotherapy for malignant disease
- severe chronic cardiac or pulmonary disease (NYHA III and IV)
- lifelong anticoagulant treatment
- coronary or cerebrovascular incident requiring hospitalization during the last three
months
- residence abroad
- return of unopened letter of invitation and/or reminder, or message of death of the
subject (not updated in Population Registry)
- failure to provide written informed consent
- screening colonoscopy within 10 years
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Outcome Measure:
Percentage of invitees attending screening colonoscopy in each invitation letter group
Outcome Time Frame:
3 months from the primary assigned screening appointment date
Safety Issue:
No
Principal Investigator
Jaroslaw Regula, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Center of Oncology Institute
Authority:
Poland: Ethics Committee
Study ID:
CO-I
NCT ID:
NCT01182922
Start Date:
August 2010
Completion Date:
August 2011
Related Keywords:
- Colorectal Cancer
- Screening
- Attendance
- Colorectal cancer
- Screening
- Invitation letter
- Colorectal Neoplasms
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