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.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 5,100
- Locations
- 1
- Primary Endpoint
- Percentage of invitees attending screening colonoscopy in each invitation letter group
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Doctor's Information Invitation
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.
Intervention: Invitation letter (Behavioral)
Gender Preference Invitation
Standard invitation with additional information about possibility of choosing doctor's gender, mentioned below proposed date of examination
Intervention: Invitation letter (Behavioral)
Standard Invitation
Standard invitation without additional information about a doctor or possibility of choosing doctor's gender.
Intervention: Invitation letter (Behavioral)
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.(3 weeks after the date of invitation letter)