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Information About a Doctor or a Possibility of Choosing Doctor's Gender and Attendance to Screening Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01182922
First received: August 15, 2010
Last updated: November 17, 2011
Last verified: November 2011
History of Changes

August 15, 2010
November 17, 2011
August 2010
March 2011   (final data collection date for primary outcome measure)
Percentage of invitees attending screening colonoscopy in each invitation letter group [ Time Frame: 3 months from the primary assigned screening appointment date ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01182922 on ClinicalTrials.gov Archive Site
Percentage of forms with consent for examination, sent back after invitation letter but before reminding letter. Differences in attendance between men and women depending on type of the invitation. [ Time Frame: 3 weeks after the date of invitation letter ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Information About a Doctor or a Possibility of Choosing Doctor's Gender and Attendance to Screening Colonoscopy
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.

The purpose of the study is to investigate whether the information about a doctor or possibility to choose doctor's gender included in invitation letter is associated with attendance rate to screening colonoscopy.

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.
Interventional
Phase 0
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
  • Colorectal Cancer
  • Screening
Behavioral: Invitation letter
Invitation letter sent 6 weeks prior to prespecified screening colonoscopy appointment date and followed by reminder letter within 3 weeks if no response is received.
  • Active Comparator: Doctor's Information Invitation
    Standard invitation with additional leaflet containing information concerning particular doctor performing the examination, that is: his personal data (name, surname, academic title, workplace, picture) and data concerning experience and achievements of the center where he is employed.
    Intervention: Behavioral: Invitation letter
  • Active Comparator: Gender Preference Invitation
    Standard invitation with additional information about possibility of choosing doctor's gender, mentioned below proposed date of examination
    Intervention: Behavioral: Invitation letter
  • Active Comparator: Standard Invitation
    Standard invitation without additional information about a doctor or possibility of choosing doctor's gender.
    Intervention: Behavioral: Invitation letter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5100
August 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
55 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01182922
CO-I
No
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Not Provided
Study Director: Jaroslaw Regula, MD, PhD Center of Oncology Institute
Principal Investigator: Krzysztof Skoczylas, MD Center of Oncology Institute
Study Chair: Michal F Kaminski, MD Center of Oncology Institute
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
November 2011

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