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
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Screening
Behavioral: Invitation letter
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: 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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5100
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: Gender Preference Invitation
Standard invitation with additional information about possibility of choosing doctor's gender, mentioned below proposed date of examination
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: Standard Invitation
Standard invitation without additional information about a doctor or possibility of choosing doctor's gender.
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.

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182922

Locations
Poland
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology,
Warsaw, Poland, 02-781
Sponsors and Collaborators
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Investigators
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
  More Information

No publications provided

Responsible Party: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier: NCT01182922     History of Changes
Other Study ID Numbers: CO-I
Study First Received: August 15, 2010
Last Updated: November 17, 2011
Health Authority: Poland: Ethics Committee

Keywords provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:
Attendance
Colorectal cancer
Screening
Invitation letter

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 August 28, 2014