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

Early Phase 1

Completed

• Conditions: Colorectal Cancer; Screening
• Interventions: Behavioral: Invitation letter

• Registration Number: NCT01182922
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-15
• Study First Submitted QC: 2010-08-15
• Study First Posted: 2010-08-17
• Primary Completion: 2011-03
• Study Completion: 2011-08
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-17
• Last Update Posted: 2011-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doctor's Information Invitation	Invitation letter	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.
Gender Preference Invitation	Invitation letter	Standard invitation with additional information about possibility of choosing doctor's gender, mentioned below proposed date of examination
Standard Invitation	Invitation letter	Standard invitation without additional information about a doctor or possibility of choosing doctor's gender.

Primary Outcome Measures

Name	Time	Method
Percentage of invitees attending screening colonoscopy in each invitation letter group	3 months from the primary assigned screening appointment date

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology,; 🇵🇱 Warsaw, Poland