Clinical trial NCT01182922: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Colorectal Cancer
Screening
Keywords: Attendance
Colorectal cancer
Screening
Invitation letter
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 5100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Percentage of invitees attending screening colonoscopy in each invitation letter group
timeFrame: 3 months from the primary assigned screening appointment date
Secondary outcomes:
measure: 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.
timeFrame: 3 weeks after the date of invitation letter
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology,
Study officials:
affiliation: Center of Oncology Institute
name: Jaroslaw Regula, MD, PhD
role: STUDY_DIRECTOR
affiliation: Center of Oncology Institute
name: Krzysztof Skoczylas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center of Oncology Institute
name: Michal F Kaminski, MD
role: STUDY_CHAIR
References: