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

Primary Purpose

Colorectal Cancer, Screening

Status

Completed

Phase

Early Phase 1

Locations

Poland

Study Type

Interventional

Intervention

Invitation letter

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Attendance, Colorectal cancer, Screening, Invitation letter

Eligibility Criteria

55 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Doctor's Information Invitation

Gender Preference Invitation

Standard Invitation

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Percentage of invitees attending screening colonoscopy in each invitation letter group

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.

Full Information

NCT ID

NCT01182922

First Posted

August 15, 2010

Last Updated

November 17, 2011

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

1. Study Identification

Unique Protocol Identification Number

NCT01182922

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Screening

Keywords

Attendance, Colorectal cancer, Screening, Invitation letter

7. Study Design

Primary Purpose

Screening

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

5100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Doctor's Information Invitation

Arm Type

Active Comparator

Arm Description

Arm Title

Gender Preference Invitation

Arm Type

Active Comparator

Arm Description

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

Arm Title

Standard Invitation

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Invitation letter

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of invitees attending screening colonoscopy in each invitation letter group

Time Frame

3 months from the primary assigned screening appointment date

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaroslaw Regula, MD, PhD

Organizational Affiliation

Center of Oncology Institute

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Krzysztof Skoczylas, MD

Organizational Affiliation

Center of Oncology Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michal F Kaminski, MD

Organizational Affiliation

Center of Oncology Institute

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Warsaw

ZIP/Postal Code

02-781

Country

Poland

12. IPD Sharing Statement

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

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