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

Early Phase 1CompletedNCT01182922

Maria Sklodowska-Curie National Research Institute of Oncology5,100 enrolled

Overview

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 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

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

5,100

Conditions

Colorectal Cancer Screening

Interventions

Invitation letterBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Warsaw, Poland

Outcomes

Primary Outcomes

Percentage of invitees attending screening colonoscopy in each invitation letter group

Time frame: 3 months from the primary assigned screening appointment date

Secondary Outcomes

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

Data from ClinicalTrials.gov

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