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

November 17, 2011 updated by: Maria Sklodowska-Curie National Research Institute of Oncology

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02-781
        • The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of invitees attending screening colonoscopy in each invitation letter group
Time Frame: 3 months from the primary assigned screening appointment date
3 months from the primary assigned screening appointment date

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 weeks after the date of invitation letter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sklodowska-Curie National Research 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

August 15, 2010

First Submitted That Met QC Criteria

August 15, 2010

First Posted (ESTIMATE)

August 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 18, 2011

Last Update Submitted That Met QC Criteria

November 17, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO-I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe