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

Study Overview
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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.

Official Title
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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.

Conditions
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Colorectal Cancer, Screening

Intervention / Treatment
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* Behavioral: Invitation letter


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Doctor's Information Invitation<br>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<br>* 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.<br>|
| Active Comparator: Gender Preference Invitation<br>Standard invitation with additional information about possibility of choosing doctor's gender, mentioned below proposed date of examination | Behavioral: Invitation letter<br>* 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.<br>|
| Active Comparator: Standard Invitation<br>Standard invitation without additional information about a doctor or possibility of choosing doctor's gender. | Behavioral: Invitation letter<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 3 weeks after the date of invitation letter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attendance, Colorectal cancer, Screening, Invitation letter