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

NCT ID: NCT01182922

Last Updated: 2011-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

5100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer Screening

Keywords

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Attendance Colorectal cancer Screening Invitation letter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Invitation letter

Intervention Type BEHAVIORAL

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.

Gender Preference Invitation

Standard invitation with additional information about possibility of choosing doctor's gender, mentioned below proposed date of examination

Group Type ACTIVE_COMPARATOR

Invitation letter

Intervention Type BEHAVIORAL

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.

Standard Invitation

Standard invitation without additional information about a doctor or possibility of choosing doctor's gender.

Group Type ACTIVE_COMPARATOR

Invitation letter

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jaroslaw Regula, MD, PhD

Role: STUDY_DIRECTOR

Center of Oncology Institute

Krzysztof Skoczylas, MD

Role: PRINCIPAL_INVESTIGATOR

Center of Oncology Institute

Michal F Kaminski, MD

Role: STUDY_CHAIR

Center of Oncology Institute

Locations

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The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology,

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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CO-I

Identifier Type: -

Identifier Source: org_study_id