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

Maria Sklodowska-Curie National Research Institute of Oncology

Status and phase

Completed

Early Phase 1

Conditions

Screening

Colorectal Cancer

Treatments

Behavioral: Invitation letter

Study type

Interventional

Funder types

Other

Identifiers

NCT01182922

CO-I

Details and patient eligibility

About

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.

Full 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.

Enrollment

5,100 patients

Sex

All

Ages

55 to 64 years old

Volunteers

No 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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

5,100 participants in 3 patient groups

Doctor's Information Invitation

Active Comparator group

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.

Treatment:

Behavioral: Invitation letter

Gender Preference Invitation

Active Comparator group

Description:

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

Treatment:

Behavioral: Invitation letter

Standard Invitation

Active Comparator group

Description:

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